<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03809910</url>
  </required_header>
  <id_info>
    <org_study_id>208112</org_study_id>
    <nct_id>NCT03809910</nct_id>
  </id_info>
  <brief_title>Dental Plaque Removal Ability of Prototype Power Toothbrush Versus a Manual Toothbrush in Healthy Participants</brief_title>
  <official_title>An Exploratory, Randomized, Single Center, Partial Crossover, Clinical Study to Evaluate the Dental Plaque Removal Ability of a Prototype Power Toothbrush Versus a Manual Toothbrush After a Single Tooth Brushing Event</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the ability of a prototype power toothbrush (PTB) versus&#xD;
      a manual toothbrush in healthy, right-handed manual toothbrush (MTB) participants with no&#xD;
      signs of periodontal disease or excessive recession to remove dental plaque after a single&#xD;
      tooth brushing event. Prior to each treatment visit, participants will abstain from oral&#xD;
      hygiene for a period of 12 hours preceding a pre-brushing dental plaque evaluation.&#xD;
      Participants will then brush once under supervision for 2 minutes in 'Gum line' mode and&#xD;
      1-minute in 'Interdental' mode after which re-disclosing and a post-brushing plaque&#xD;
      assessment will be carried out.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an exploratory, randomized, single center, 4-treatment, 3-period, partial&#xD;
      crossover study in healthy participants with no signs of periodontal disease or excessive&#xD;
      recession, to assess a prototype PTB in removing dental plaque after a single brushing event.&#xD;
&#xD;
      At the screening visit, following provision of written informed consent, participants will be&#xD;
      provided PTB training to familiarize themselves with how the different modes and different&#xD;
      PTBs operate. Eligible participants will be provided with a washout fluoride toothpaste and&#xD;
      toothbrush for use at home during the study.&#xD;
&#xD;
      Participants will then be scheduled to attend appointment after a minimum of 3 days. For each&#xD;
      treatment visit, participants must abstain from oral hygiene for a period of 12hours,&#xD;
      immediately preceding the pre-brushing dental plaque evaluation.&#xD;
&#xD;
      All the participants will undergo an oral soft tissue (OST) examination followed by plaque&#xD;
      disclosing and a pre-brushing dental plaque assessment using the Rustogi Modified Navy Plaque&#xD;
      Index (RMNPI) index. In in periods 1 and 2, participants will be randomized to the study&#xD;
      treatment sequence with the prototype PTB and MTB used in a crossover manner and participants&#xD;
      will then brush under supervision followed by disclosing and post-brushing plaque&#xD;
      assessments. Participants assigned to the prototype PTB, it will be used for 2 minutes in&#xD;
      'Gum line' mode brushing and 1-minute brushing in 'Interdental' mode.&#xD;
&#xD;
      Participants will then brush once (1.3 grams [g] ± 0.1 g of assigned toothpaste), under&#xD;
      supervision of study staff after which disclosing, and a post-brushing plaque assessment will&#xD;
      be carried out.&#xD;
&#xD;
      Participants will be allowed to brush with the washout paste following the post assessment&#xD;
      plaque assessments. A minimum of three days washout period will follow each treatment period&#xD;
      during which period Participants will brush with a standard washout toothpaste&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2019</start_date>
  <completion_date type="Actual">August 9, 2019</completion_date>
  <primary_completion_date type="Actual">August 9, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Whole Mouth Rustogi Modified Navy Plaque Index (RMNPI) Score From Pre-Brushing to Post-Brushing (When Prototype Power Toothbrush [PTB] Was Used in 'Gumline' Mode vs a Reference Manual Toothbrush [MTB])</measure>
    <time_frame>After 2 minutes of brushing</time_frame>
    <description>Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (sites A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)</measure>
    <time_frame>After 2 minutes of brushing</time_frame>
    <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)</measure>
    <time_frame>After 2 minutes of brushing</time_frame>
    <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Whole Mouth RMNPI Score From Pre-brushing to Post-brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)</measure>
    <time_frame>After 3 minutes of brushing</time_frame>
    <description>Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode followed by 'Interdental' mode) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)</measure>
    <time_frame>After 3 minutes of brushing</time_frame>
    <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)</measure>
    <time_frame>After 3 minutes of brushing</time_frame>
    <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)</measure>
    <time_frame>After 3 minutes of brushing</time_frame>
    <description>Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)</measure>
    <time_frame>After 3 minutes of brushing</time_frame>
    <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)</measure>
    <time_frame>After 3 minutes of brushing</time_frame>
    <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)</measure>
    <time_frame>After 3 minutes of brushing</time_frame>
    <description>Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)</measure>
    <time_frame>After 3 minutes of brushing</time_frame>
    <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)</measure>
    <time_frame>After 3 minutes of brushing</time_frame>
    <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Dental Plaque</condition>
  <arm_group>
    <arm_group_label>Prototype PTB (Gum line mode)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will brush their teeth with prototype power toothbrush in Gum line mode with a fluoride toothpaste</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prototype PTB (Combined mode)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will brush their teeth with prototype power toothbrush in &quot;Gum line&quot; mode with a fluoride toothpaste. Following this, participants will brush their teeth with prototype power toothbrush in 'Interdental' mode with a fluoride toothpaste.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference MTB</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will brush their teeth with manual toothbrush and fluoride toothpaste.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference PTB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will brush their teeth with reference power toothbrush and fluoride toothpaste.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Reference MTB</intervention_name>
    <description>Participants will brush their teeth with manual toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 1-timed minute under supervision of study staff.</description>
    <arm_group_label>Reference MTB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Reference PTB</intervention_name>
    <description>Participants will brush their teeth with power toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute under supervision of study staff.</description>
    <arm_group_label>Reference PTB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prototype PTB (Gum line mode)</intervention_name>
    <description>Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in &quot;Gum Line&quot; mode under supervision of study staff.</description>
    <arm_group_label>Prototype PTB (Gum line mode)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prototype PTB (Combined mode)</intervention_name>
    <description>Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in &quot;Gum Line&quot; mode and 1-timed minute in &quot;Interdental&quot; mode under supervision of study staff.</description>
    <arm_group_label>Prototype PTB (Combined mode)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        An individual must meet all the following inclusion criteria to be eligible for enrollment&#xD;
        into the study:&#xD;
&#xD;
          -  Participant provision of a signed and dated informed consent document indicating that&#xD;
             the participant has been informed of all pertinent aspects of the study before any&#xD;
             assessment is performed.&#xD;
&#xD;
          -  Participant is male or female who, at the time of screening, is between the ages of 18&#xD;
             and 65 years, inclusive.&#xD;
&#xD;
          -  A participant who is willing and able to comply with scheduled visits, treatment plan,&#xD;
             and other study procedures.&#xD;
&#xD;
          -  A participant that successfully completes the investigational device training visit,&#xD;
             understands and is willing to follow product usage instructions, in the opinion of the&#xD;
             investigator or designee.&#xD;
&#xD;
          -  A participant in good general and mental health, in the opinion of the investigator or&#xD;
             medically qualified designee; no clinically significant and relevant abnormalities in&#xD;
             medical history or upon oral examination.&#xD;
&#xD;
          -  A participant with good dental health based on medical history and oral soft tissue&#xD;
             examination at screening.&#xD;
&#xD;
          -  A participant with a minimum of 20 permanent gradable teeth (gradable teeth are those&#xD;
             where restorative materials cover less than 25% of the tooth surface graded).&#xD;
&#xD;
          -  For continued eligibility after the Screening visit, a participant must have a mean&#xD;
             RMNPI whole mouth plaque score of ≥ 0.6 at Visit 2, 3, 4 and 5.&#xD;
&#xD;
          -  A participant that regularly uses a manual toothbrush in their daily oral hygiene&#xD;
             routine.&#xD;
&#xD;
          -  A participant that regularly brushes their teeth with their right hand.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        An individual who meets any of the following exclusion criteria will not be eligible for&#xD;
        enrollment into the study:&#xD;
&#xD;
          -  A participant who is an employee of the investigational site, either directly involved&#xD;
             in the conduct of the study or a member of their immediate family; or an employee of&#xD;
             the investigational site otherwise supervised by the investigator; or, a GSK CH&#xD;
             employee directly involved in the conduct of the study or a member of their immediate&#xD;
             family.&#xD;
&#xD;
          -  A participant who has participated in other studies (including non-medicinal studies)&#xD;
             involving investigational product(s) within 30 days prior to study entry and/or during&#xD;
             study participation.&#xD;
&#xD;
          -  A participant with, in the opinion of the investigator or medically qualified&#xD;
             designee, an acute or chronic medical or psychiatric condition or laboratory&#xD;
             abnormality that may increase the risk associated with study participation or&#xD;
             investigational product administration or may interfere with the interpretation of&#xD;
             study results and, in the judgment of the investigator or medically qualified&#xD;
             designee, would make the participant inappropriate for entry into this study.&#xD;
&#xD;
          -  A participant who is a pregnant female (evidenced by positive urine pregnancy test).&#xD;
&#xD;
          -  A participant who is a breastfeeding female.&#xD;
&#xD;
          -  A male participant able to father children or female participant of childbearing&#xD;
             potential and at risk for pregnancy must agree to use a highly effective method of&#xD;
             contraception throughout the study and for 5 days after the last assigned treatment.&#xD;
&#xD;
          -  A female participant who is of childbearing potential and are sexually active and at&#xD;
             risk for pregnancy must agree to use a highly effective method of contraception&#xD;
             consistently and correctly for the duration of the active study period and for 5 days&#xD;
             after the last assigned treatment.&#xD;
&#xD;
          -  A participant with known or suspected intolerance or hypersensitivity to the study&#xD;
             materials (or closely related compounds) or any of their stated ingredients.&#xD;
&#xD;
          -  A participant who, in the opinion of the investigator or medically qualified designee,&#xD;
             should not participate in the study.&#xD;
&#xD;
          -  A participant unwilling or unable to comply with the following Lifestyle&#xD;
             Considerations: a) Participants will be requested not to have any elective dental&#xD;
             procedures including teeth professionally cleaned, excluding emergency dental&#xD;
             treatment ; b)Participants will be requested not to have whitening treatment&#xD;
             (including professional or at home use) during the duration of the study; c)&#xD;
             Participants will not be permitted to use any other oral care products (i.e. oral&#xD;
             rinses, tongue cleaners, whitening, bleaching products) besides the products supplied&#xD;
             for this study; d) Eligible participants will be asked to stop using their regular&#xD;
             dentifrice and toothbrush from the Screening visit for the duration of the study; e)&#xD;
             Participants should abstain from interproximal cleaning (i.e. dental floss, oral&#xD;
             irrigators, interdental brushes) for the duration of the study. Participants will be&#xD;
             permitted to use toothpicks or floss to remove impacted food only ; f) Prior to Visit&#xD;
             2, 3 and 4:Participants should abstain from all oral hygiene procedures for at least12&#xD;
             hours prior to the scheduled time of their Visit 2, 3 and 4 appointments; g ) On study&#xD;
             visit days (Visits 2, 3 and 4) participants must abstain from all food and drink&#xD;
             (except water) at least 4 hours prior to their scheduled visits until all measurements&#xD;
             have been taken. Water is permitted until 1 hour prior to investigational product&#xD;
             administration; h) Participants must abstain from chewing gum and consuming&#xD;
             confectionary containing xylitol (e.g. mints) at least 4 hours prior to their&#xD;
             scheduled visit; i) On study visit days (Visits 2, 3 and 4) participants must abstain&#xD;
             from all alcohol until all measurements have been taken; j) Participants will abstain&#xD;
             from caffeine-containing products for at least 4 hours prior to their scheduled Visit&#xD;
             2, 3 and 4 until all measurements have been take; k) Participant will abstain from&#xD;
             smoking, chewing tobacco, or smoking E-cigarettes throughout the study.&#xD;
&#xD;
          -  A participant who has received a dental prophylaxis within 4 weeks of Screening visit.&#xD;
&#xD;
          -  A participant who has received teeth bleaching/whitening (including professional or at&#xD;
             home use) within 8 weeks prior to Screening visit.&#xD;
&#xD;
          -  A participant who is receiving or has received treatment for periodontal disease&#xD;
             (including surgery) within 12 months of Screening.&#xD;
&#xD;
          -  A participant who has received orthodontic therapy or scaling or root planning within&#xD;
             3 months of Screening.&#xD;
&#xD;
          -  A participant with high levels of extrinsic stain or calculus deposits which might&#xD;
             interfere with dental plaque assessments.&#xD;
&#xD;
          -  A participant that has current active caries, excessive gingival recession, severe&#xD;
             gingivitis or periodontitis that may, in the opinion of the investigator, compromise&#xD;
             the study or the oral health of the participant if they participate in the study.&#xD;
&#xD;
          -  A participant with the presence of oral or peri-oral ulceration including herpetic&#xD;
             lesions at the time of screening.&#xD;
&#xD;
          -  A participant who is at risk of spasms.&#xD;
&#xD;
          -  A participant with restorations in a poor state of repair that may, in the opinion of&#xD;
             the investigator, compromise the study or the oral health of the participant if they&#xD;
             participate in the study.&#xD;
&#xD;
          -  A participant with the presence of orthodontic bands or appliances, extensive crowns,&#xD;
             partial or full dentures, or fixed retainers on the maxillary or mandibular teeth.&#xD;
&#xD;
          -  A participant with a tongue or lip piercing, or any other oral feature that could&#xD;
             interfere with the usage of the toothbrush.&#xD;
&#xD;
          -  A participant who has used antibiotic treatment within 14 days prior to Screening&#xD;
             visit.&#xD;
&#xD;
          -  A participant with diagnosed xerostomia or taking any medication that in view of the&#xD;
             investigator causes xerostomia.&#xD;
&#xD;
          -  A participant with any electronic medical devices (such as pacemakers).&#xD;
&#xD;
          -  A participant that has used a chlorhexidine mouthwash within 14 days of Screening&#xD;
             visit or used any oral care product that under the criteria of the principal&#xD;
             investigator could interfere with dental plaque formation.&#xD;
&#xD;
          -  A participant unwilling to abstain from using other oral care products besides those&#xD;
             assigned to them in the study.&#xD;
&#xD;
          -  A participant with a recent history (within past year) of alcohol or other substance&#xD;
             abuse.&#xD;
&#xD;
          -  A participant that smokes or uses chew tobacco, or regularly smokes E-cigarettes.&#xD;
&#xD;
          -  A participant who has previously been enrolled in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mississauga</city>
        <zip>L5N 6J2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>August 7, 2020</results_first_submitted>
  <results_first_submitted_qc>September 14, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 16, 2020</results_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral Health, Dental care, Lifestyle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Plaque</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03809910/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03809910/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at single center in Canada. A total of 40 participants were screened, of whom 39 were randomized for treatment and 1 withdrew consent prior to randomization.</recruitment_details>
      <pre_assignment_details>Participants received 4 treatments in 3 periods: 1. Prototype power toothbrush (PTB) in 'Gumline' mode, 2. Prototype PTB in 'Combined' mode ('Gumline' mode followed by 'Interdental' mode), 3. Reference manual toothbrush (MTB), 4. Reference PTB</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sequence A-B-C</title>
          <description>Participants randomized to this group brushed their teeth as follows in supervision of study staff during site visit: Prototype PTB (A) in Period 1 (for 2 timed minutes [min] in 'Gumline' mode and 1 timed min in 'Interdental' mode) followed by Reference MTB (B) in Period 2 (for 1 timed min) and Reference PTB (C) in Period 3 (for 2 timed min). Clinical assessments were performed after 'Gumline' mode and 'Interdental' mode in same treatment period. Each treatment period was followed by a minimum of 3-days washout period and prior to each site visit, participants abstained from all oral hygiene for at least 12 hours. Participants received a fluoride toothpaste and manual toothbrush to use at home during washout period, recorded each brushing occasion (at home) and time of their last brushing prior to their next scheduled appointment on their diary. Overall study duration from first subject first visit (FSFV) to last subject last visit (LSLV) was 32 days.</description>
        </group>
        <group group_id="P2">
          <title>Sequence B-A-C</title>
          <description>Participants randomized to this group brushed their teeth as follows in supervision of study staff during site visit: Reference MTB (B) in Period 1 (for 1 timed minute) followed by Prototype PTB (A) in Period 2 (for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode) and Reference PTB in Period 3 (C) (for 2 timed minutes). Clinical assessments were performed after 'Gumline' mode and after 'Interdental' mode in same treatment period. Each treatment period was followed by a minimum of 3-days washout period and prior to each site visit, participants abstained from all oral hygiene for at least 12 hours. Participants received a fluoride toothpaste and manual toothbrush to use at home during the washout period and recorded each brushing occasion (at home) and time of their last brushing prior to their next scheduled appointment on their diary. Overall study duration from FSFV to LSLV was 32 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1 (Visit 2)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period 1 (3 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2 (Visit 3)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period 2 (3 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 3 (Visit 4)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Modified intent-to-treat (m-ITT) population included all participants who are randomized, received at least one of the study treatments and provide at least one post-brushing assessment of efficacy.</population>
      <group_list>
        <group group_id="B1">
          <title>All Treatment Combined</title>
          <description>All randomized participants received treatment in either sequence A-B-C or sequence B-A-C. Participants in the product sequence A-B-C applied Prototype PTB (A) in Period 1 followed by Reference MTB (B) in Period 2 and Reference PTB (C) in Period 3, whereas, in product sequence B-A-C participants applied Reference MTB (B) in Period 1 followed by Prototype PTB (A) in Period 2 and Reference PTB (C) in Period 3.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.2" spread="14.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Whole Mouth Rustogi Modified Navy Plaque Index (RMNPI) Score From Pre-Brushing to Post-Brushing (When Prototype Power Toothbrush [PTB] Was Used in 'Gumline' Mode vs a Reference Manual Toothbrush [MTB])</title>
        <description>Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (sites A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
        <time_frame>After 2 minutes of brushing</time_frame>
        <population>Modified Intent-to-Treat (mITT) Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Prototype PTB &quot;Gumline&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode. Clinical assessments were performed after the 'Gumline' mode.</description>
          </group>
          <group group_id="O2">
            <title>Reference MTB</title>
            <description>Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Whole Mouth Rustogi Modified Navy Plaque Index (RMNPI) Score From Pre-Brushing to Post-Brushing (When Prototype Power Toothbrush [PTB] Was Used in 'Gumline' Mode vs a Reference Manual Toothbrush [MTB])</title>
          <description>Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (sites A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
          <population>Modified Intent-to-Treat (mITT) Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.38" spread="0.086"/>
                    <measurement group_id="O2" value="-0.32" spread="0.083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.014</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>-0.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)</title>
        <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
        <time_frame>After 2 minutes of brushing</time_frame>
        <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Prototype PTB &quot;Gumline&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode. Clinical assessments were performed after the 'Gumline' mode.</description>
          </group>
          <group group_id="O2">
            <title>Reference MTB</title>
            <description>Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)</title>
          <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
          <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" spread="0.156"/>
                    <measurement group_id="O2" value="-0.38" spread="0.166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.025</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>-0.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)</title>
        <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
        <time_frame>After 2 minutes of brushing</time_frame>
        <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Prototype PTB &quot;Gumline&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode. Clinical assessments were performed after the 'Gumline' mode.</description>
          </group>
          <group group_id="O2">
            <title>Reference MTB</title>
            <description>Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)</title>
          <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
          <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" spread="0.175"/>
                    <measurement group_id="O2" value="-0.55" spread="0.140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.025</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.16</ci_lower_limit>
            <ci_upper_limit>-0.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Whole Mouth RMNPI Score From Pre-brushing to Post-brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)</title>
        <description>Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode followed by 'Interdental' mode) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
        <time_frame>After 3 minutes of brushing</time_frame>
        <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Prototype PTB &quot;Combined&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode.</description>
          </group>
          <group group_id="O2">
            <title>Reference MTB</title>
            <description>Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Whole Mouth RMNPI Score From Pre-brushing to Post-brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)</title>
          <description>Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode followed by 'Interdental' mode) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
          <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.54" spread="0.054"/>
                    <measurement group_id="O2" value="-0.32" spread="0.083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.014</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.25</ci_lower_limit>
            <ci_upper_limit>-0.19</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)</title>
        <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
        <time_frame>After 3 minutes of brushing</time_frame>
        <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Prototype PTB &quot;Combined&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode.</description>
          </group>
          <group group_id="O2">
            <title>Reference MTB</title>
            <description>Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)</title>
          <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
          <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.76" spread="0.141"/>
                    <measurement group_id="O2" value="-0.38" spread="0.166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.38</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.025</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.43</ci_lower_limit>
            <ci_upper_limit>-0.33</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)</title>
        <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
        <time_frame>After 3 minutes of brushing</time_frame>
        <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Prototype PTB &quot;Combined&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode.</description>
          </group>
          <group group_id="O2">
            <title>Reference MTB</title>
            <description>Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)</title>
          <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
          <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.90" spread="0.106"/>
                    <measurement group_id="O2" value="-0.55" spread="0.140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.025</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.39</ci_lower_limit>
            <ci_upper_limit>-0.29</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)</title>
        <description>Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
        <time_frame>After 3 minutes of brushing</time_frame>
        <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Prototype PTB &quot;Gumline&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode. Clinical assessments were performed after the 'Gumline' mode.</description>
          </group>
          <group group_id="O2">
            <title>Prototype PTB &quot;Combined&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)</title>
          <description>Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
          <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.38" spread="0.086"/>
                    <measurement group_id="O2" value="-0.54" spread="0.054"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.014</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>0.18</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)</title>
        <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
        <time_frame>After 3 minutes of brushing</time_frame>
        <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Prototype PTB &quot;Gumline&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode. Clinical assessments were performed after the 'Gumline' mode.</description>
          </group>
          <group group_id="O2">
            <title>Prototype PTB &quot;Combined&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)</title>
          <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
          <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" spread="0.156"/>
                    <measurement group_id="O2" value="-0.76" spread="0.141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.26</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.025</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.21</ci_lower_limit>
            <ci_upper_limit>0.31</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)</title>
        <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
        <time_frame>After 3 minutes of brushing</time_frame>
        <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Prototype PTB &quot;Gumline&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode. Clinical assessments were performed after the 'Gumline' mode.</description>
          </group>
          <group group_id="O2">
            <title>Prototype PTB &quot;Combined&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)</title>
          <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
          <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" spread="0.175"/>
                    <measurement group_id="O2" value="-0.90" spread="0.106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.025</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.18</ci_lower_limit>
            <ci_upper_limit>0.28</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)</title>
        <description>Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
        <time_frame>After 3 minutes of brushing</time_frame>
        <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Prototype PTB &quot;Gumline&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode. Clinical assessments were performed after the 'Gumline' mode.</description>
          </group>
          <group group_id="O2">
            <title>Prototype PTB &quot;Combined&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode.</description>
          </group>
          <group group_id="O3">
            <title>Reference PTB</title>
            <description>Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)</title>
          <description>Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
          <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.38" spread="0.086"/>
                    <measurement group_id="O2" value="-0.54" spread="0.054"/>
                    <measurement group_id="O3" value="-0.50" spread="0.061"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.014</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.09</ci_lower_limit>
            <ci_upper_limit>0.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0214</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.014</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.06</ci_lower_limit>
            <ci_upper_limit>-0.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)</title>
        <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
        <time_frame>After 3 minutes of brushing</time_frame>
        <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Prototype PTB &quot;Gumline&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode. Clinical assessments were performed after the 'Gumline' mode.</description>
          </group>
          <group group_id="O2">
            <title>Prototype PTB &quot;Combined&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode.</description>
          </group>
          <group group_id="O3">
            <title>Reference PTB</title>
            <description>Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)</title>
          <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
          <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" spread="0.156"/>
                    <measurement group_id="O2" value="-0.76" spread="0.141"/>
                    <measurement group_id="O3" value="-0.67" spread="0.102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.025</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>0.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0010</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.025</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.14</ci_lower_limit>
            <ci_upper_limit>-0.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)</title>
        <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
        <time_frame>After 3 minutes of brushing</time_frame>
        <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Prototype PTB &quot;Gumline&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode. Clinical assessments were performed after the 'Gumline' mode.</description>
          </group>
          <group group_id="O2">
            <title>Prototype PTB &quot;Combined&quot;</title>
            <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode.</description>
          </group>
          <group group_id="O3">
            <title>Reference PTB</title>
            <description>Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)</title>
          <description>Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).</description>
          <population>mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" spread="0.175"/>
                    <measurement group_id="O2" value="-0.90" spread="0.106"/>
                    <measurement group_id="O3" value="-0.86" spread="0.095"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.025</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.15</ci_lower_limit>
            <ci_upper_limit>0.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1652</p_value>
            <p_value_desc>Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.026</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>37 Days</time_frame>
      <desc>Safety population: all participants who were eligible to participate in the study and had participated in the Supervised PTB Training. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.</desc>
      <group_list>
        <group group_id="E1">
          <title>Prototype PTB (A)</title>
          <description>Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode in same treatment period.</description>
        </group>
        <group group_id="E2">
          <title>Reference MTB (B)</title>
          <description>Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.</description>
        </group>
        <group group_id="E3">
          <title>Reference PTB (C)</title>
          <description>Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03809910
org study id: 208112
nct id: NCT03809910
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the ability of a prototype power toothbrush (PTB) versus
      a manual toothbrush in healthy, right-handed manual toothbrush (MTB) participants with no
      signs of periodontal disease or excessive recession to remove dental plaque after a single
      tooth brushing event. Prior to each treatment visit, participants will abstain from oral
      hygiene for a period of 12 hours preceding a pre-brushing dental plaque evaluation.
      Participants will then brush once under supervision for 2 minutes in 'Gum line' mode and
      1-minute in 'Interdental' mode after which re-disclosing and a post-brushing plaque
      assessment will be carried out.
This study is an exploratory, randomized, single center, 4-treatment, 3-period, partial
      crossover study in healthy participants with no signs of periodontal disease or excessive
      recession, to assess a prototype PTB in removing dental plaque after a single brushing event.

      At the screening visit, following provision of written informed consent, participants will be
      provided PTB training to familiarize themselves with how the different modes and different
      PTBs operate. Eligible participants will be provided with a washout fluoride toothpaste and
      toothbrush for use at home during the study.

      Participants will then be scheduled to attend appointment after a minimum of 3 days. For each
      treatment visit, participants must abstain from oral hygiene for a period of 12hours,
      immediately preceding the pre-brushing dental plaque evaluation.

      All the participants will undergo an oral soft tissue (OST) examination followed by plaque
      disclosing and a pre-brushing dental plaque assessment using the Rustogi Modified Navy Plaque
      Index (RMNPI) index. In in periods 1 and 2, participants will be randomized to the study
      treatment sequence with the prototype PTB and MTB used in a crossover manner and participants
      will then brush under supervision followed by disclosing and post-brushing plaque
      assessments. Participants assigned to the prototype PTB, it will be used for 2 minutes in
      'Gum line' mode brushing and 1-minute brushing in 'Interdental' mode.

      Participants will then brush once (1.3 grams [g] ± 0.1 g of assigned toothpaste), under
      supervision of study staff after which disclosing, and a post-brushing plaque assessment will
      be carried out.

      Participants will be allowed to brush with the washout paste following the post assessment
      plaque assessments. A minimum of three days washout period will follow each treatment period
      during which period Participants will brush with a standard washout toothpaste
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Whole Mouth Rustogi Modified Navy Plaque Index (RMNPI) Score From Pre-Brushing to Post-Brushing (When Prototype Power Toothbrush [PTB] Was Used in 'Gumline' Mode vs a Reference Manual Toothbrush [MTB])
time frame: After 2 minutes of brushing
description: Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (sites A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).
measure: Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)
time frame: After 2 minutes of brushing
description: Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).
measure: Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)
time frame: After 2 minutes of brushing
description: Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).
measure: Change in Whole Mouth RMNPI Score From Pre-brushing to Post-brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)
time frame: After 3 minutes of brushing
description: Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode followed by 'Interdental' mode) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).
measure: Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)
time frame: After 3 minutes of brushing
description: Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).
measure: Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)
time frame: After 3 minutes of brushing
description: Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).
measure: Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)
time frame: After 3 minutes of brushing
description: Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).
measure: Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)
time frame: After 3 minutes of brushing
description: Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).
measure: Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)
time frame: After 3 minutes of brushing
description: Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).
measure: Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)
time frame: After 3 minutes of brushing
description: Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).
measure: Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)
time frame: After 3 minutes of brushing
description: Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).
measure: Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)
time frame: After 3 minutes of brushing
description: Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).
arm group label: Prototype PTB (Gum line mode)
arm group type: Experimental
description: Participants will brush their teeth with prototype power toothbrush in Gum line mode with a fluoride toothpaste
arm group label: Prototype PTB (Combined mode)
arm group type: Experimental
description: Participants will brush their teeth with prototype power toothbrush in "Gum line" mode with a fluoride toothpaste. Following this, participants will brush their teeth with prototype power toothbrush in 'Interdental' mode with a fluoride toothpaste.
arm group label: Reference MTB
arm group type: Sham Comparator
description: Participants will brush their teeth with manual toothbrush and fluoride toothpaste.
arm group label: Reference PTB
arm group type: Active Comparator
description: Participants will brush their teeth with reference power toothbrush and fluoride toothpaste.
intervention type: Device
intervention name: Reference MTB
description: Participants will brush their teeth with manual toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 1-timed minute under supervision of study staff.
arm group label: Reference MTB
intervention type: Device
intervention name: Reference PTB
description: Participants will brush their teeth with power toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute under supervision of study staff.
arm group label: Reference PTB
intervention type: Device
intervention name: Prototype PTB (Gum line mode)
description: Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in "Gum Line" mode under supervision of study staff.
arm group label: Prototype PTB (Gum line mode)
intervention type: Device
intervention name: Prototype PTB (Combined mode)
description: Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in "Gum Line" mode and 1-timed minute in "Interdental" mode under supervision of study staff.
arm group label: Prototype PTB (Combined mode)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Dental Plaque
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 