<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/NCT03285984</url>
  </required_header>
  <id_info>
    <org_study_id>202655</org_study_id>
    <nct_id>NCT03285984</nct_id>
  </id_info>
  <brief_title>Ability of Four Toothpastes to Remove Plaque</brief_title>
  <official_title>Plaque Removal Efficacy of Four Dentifrices in a Single Brushing Model</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 and compare the plaque removal efficacy of four&#xD;
      experimental toothpastes following a single timed brushing. Prior to each treatment visit,&#xD;
      participants will abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs),&#xD;
      immediately preceding a pre-brushing dental plaque evaluation. Participants will then brush&#xD;
      once under supervision for one timed minute with each dentifrice after which re-disclosing&#xD;
      and a post-brushing plaque assessment will be carried out.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a single centre, randomized, controlled, examiner blind, four treatment,&#xD;
      four period crossover design. At the screening visit, following provision of written informed&#xD;
      consent, eligible participants will be provided with a washout toothpaste and toothbrush for&#xD;
      use at home during the study and for at least 14 days prior to the first treatment visit.&#xD;
&#xD;
      Participants will then be scheduled to attend the first of four treatment visits a minimum of&#xD;
      14 days later. For each treatment visit, participants must abstain from oral hygiene for a&#xD;
      period of 24 hours (+6hrs, -2hrs), immediately preceding the pre-brushing dental plaque&#xD;
      evaluation. All the participants will undergo an oral soft tissue (OST) examination followed&#xD;
      by disclosing and a dental plaque assessment.&#xD;
&#xD;
      At the treatment visit 1 pre-brushing plaque assessment, those who develop a sufficient&#xD;
      amount of plaque (Turesky mean score ≥ 2.00) will be randomized to study treatment.&#xD;
      Participants will then brush once (1.5 grams [g] ± 0.05g of assigned toothpaste), under&#xD;
      supervision of study staff for one timed minute, with one of the four test toothpastes after&#xD;
      which re-disclosing and a post-brushing plaque assessment will be carried out. Participants&#xD;
      will be allowed to brush with the washout paste following the post assessment plaque&#xD;
      assessments.&#xD;
&#xD;
      A minimum of three days washout period will follow each treatment period during which period&#xD;
      Participants will brush with a commercial washout toothpaste. Participants will complete four&#xD;
      treatment visits and will brush once with each of the four test toothpastes throughout the&#xD;
      course of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2012</start_date>
  <completion_date type="Actual">May 8, 2012</completion_date>
  <primary_completion_date type="Actual">May 8, 2012</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>The randomization schedule will indicate the treatment order sequence. Each subject will complete all four treatment regimens, one treatment regimen in each of the four treatment periods. This randomization will use a Williams Square layout and be provided by the Biostatistics Department, GSKCH.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks</measure>
    <time_frame>Baseline to 4 Weeks</time_frame>
    <description>The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks</measure>
    <time_frame>Baseline to 4 Weeks</time_frame>
    <description>The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Dental Plaque</condition>
  <arm_group>
    <arm_group_label>Test product 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will brush once (1.5g ± 0.05g of Test product 1), under supervision of study staff for one timed minute</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test product 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will brush once (1.5g ± 0.05g of Test product 2), under supervision of study staff for one timed minute</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test product 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will brush once (1.5g ± 0.05g of Test product 3), under supervision of study staff for one timed minute</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test product 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will brush once (1.5g ± 0.05g of Test product 4), under supervision of study staff for one timed minute</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride</intervention_name>
    <description>Toothpaste containing 67 percent (%) Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride</description>
    <arm_group_label>Test product 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride</intervention_name>
    <description>Toothpaste containing 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride</description>
    <arm_group_label>Test product 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium</intervention_name>
    <description>Whitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium</description>
    <arm_group_label>Test product 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride</intervention_name>
    <description>Toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride</description>
    <arm_group_label>Test product 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Demonstrates understanding of the study and willingness to participate as evidenced by&#xD;
             voluntary written informed consent and has received a signed and dated copy of the&#xD;
             informed consent form.&#xD;
&#xD;
          -  Aged at least 18 years&#xD;
&#xD;
          -  Understands and is willing, able and likely to comply with all study procedures and&#xD;
             restrictions&#xD;
&#xD;
          -  Good general health with (in the opinion of the Investigator) no clinically&#xD;
             significant and relevant abnormalities of medical history or dental history.&#xD;
&#xD;
          -  Good dental health based on medical history and oral soft tissue examination at&#xD;
             screening&#xD;
&#xD;
          -  At least 20 gradable, natural, uncrowned teeth with both facial and lingual scoreable&#xD;
             surfaces (gradable teeth are those where restorative materials cover less than 25% of&#xD;
             the tooth surface graded)&#xD;
&#xD;
          -  Plaque Score: Mean Turesky plaque score of ≥ 2.00 at treatment visit 1 pre-brushing&#xD;
             plaque assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are known to be pregnant or who are intending to become pregnant over the&#xD;
             duration of the study&#xD;
&#xD;
          -  Women who are breast-feeding&#xD;
&#xD;
          -  Antibiotic treatment within 14 days prior to Treatment Visit 1 or throughout the study&#xD;
&#xD;
          -  Any other treatment that would interfere with the study results/conduct, at the&#xD;
             discretion of the examiner or investigator&#xD;
&#xD;
          -  Diabetes mellitus type I or II&#xD;
&#xD;
          -  Any disease systemic or localized, dental or non dental, which could put the&#xD;
             participant's health at risk or interfere with the study results/conduct, at the&#xD;
             discretion of the examiner or investigator&#xD;
&#xD;
          -  High levels of extrinsic stain or calculus deposits which might interfere with plaque&#xD;
             assessments&#xD;
&#xD;
          -  Dental condition/ disease requiring immediate treatment&#xD;
&#xD;
          -  Pre-existing sensitivity to oral care products&#xD;
&#xD;
          -  Severe gingivitis&#xD;
&#xD;
          -  Periodontitis with pocket depth &gt; 5mm affecting more than two teeth&#xD;
&#xD;
          -  Moderate or severe recession&#xD;
&#xD;
          -  Presence of orthodontic bands or appliances, extensive crowns, partial dentures, or&#xD;
             fixed retainers on the maxillary or mandibular teeth&#xD;
&#xD;
          -  Obvious active carious lesions needing immediate care&#xD;
&#xD;
          -  Intra-oral decorative tattoos, or tongue and or lip piercing&#xD;
&#xD;
          -  Oral lesions/manifestations that would impact on the outcome of the study&#xD;
&#xD;
          -  Presence of oral or peri-oral ulceration including herpetic lesions at the time of&#xD;
             screening or at baseline&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to the studymaterials (or closely&#xD;
             related compounds) or any of their stated ingredients&#xD;
&#xD;
          -  Participation in another clinical study or receipt of an investigational drug within&#xD;
             30 days of the screening visit&#xD;
&#xD;
          -  Previous participation in this study&#xD;
&#xD;
          -  Recent history (within the last year) of alcohol or other substance abuse&#xD;
&#xD;
          -  Current use of Listerine or any antimicrobial mouth rinse containing Chlorhexidine or&#xD;
             Cetrylpyridinium Chloride (CPC)&#xD;
&#xD;
          -  Participant unwilling to abstain from using chewing tobacco (with or without tobacco)&#xD;
&#xD;
          -  Participant unwilling to abstain from smoking on the morning prior to treatment visits&#xD;
&#xD;
          -  An employee of the sponsor or the study site or members of their immediate family&#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</affiliation>
  </overall_official>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>October 6, 2017</results_first_submitted>
  <results_first_submitted_qc>October 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 16, 2018</results_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Plaque</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited at a single center in the United States.</recruitment_details>
      <pre_assignment_details>A Total of 56 participants were screened and randomized in the study. All 56 participants completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Overall Study</title>
          <description>This was a single centre, randomized, controlled, examiner blind, four treatment, four period crossover design study. Each Participant received Test product 1 (Toothpaste containing 67 percent [%] sodium bicarbonate with 6 herbs plus 923 parts per million [ppm] sodium fluoride, Test product 2 (Toothpaste containing 67% sodium bicarbonate without herbs plus 923ppm sodium fluoride), Test product 3 (Whitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% weight by weight [w/w] silica plus 923ppm Sodium), and Test product 4 (Toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Test Product 1</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Test Product 2</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Test Product 3</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Test Product 4</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Randomized Participants</title>
          <description>All randomized participants were included for baseline evaluation.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="56"/>
          </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="44.1" spread="11.87"/>
                  </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="36"/>
                  </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>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="0"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks</title>
        <description>The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.</description>
        <time_frame>Baseline to 4 Weeks</time_frame>
        <population>ITT (Intent-to-treat) population was the primary analysis population, which included all the participants who were randomized and had at least one post-baseline efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product 1</title>
            <description>Participants brushed once (1.5g ± 0.05g of toothpaste containing 67 % sodium bicarbonate with 6 herbs plus 923 ppm sodium fluoride), under supervision of study staff for one timed minute.</description>
          </group>
          <group group_id="O2">
            <title>Test Product 4</title>
            <description>Participants brushed once (1.5g ± 0.05g of toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks</title>
          <description>The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.</description>
          <population>ITT (Intent-to-treat) population was the primary analysis population, which included all the participants who were randomized and had at least one post-baseline efficacy evaluation.</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="56"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.90" spread="0.308"/>
                    <measurement group_id="O2" value="2.86" spread="0.309"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.76" spread="0.514"/>
                    <measurement group_id="O2" value="1.96" spread="0.470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.13" spread="0.430"/>
                    <measurement group_id="O2" value="-0.90" spread="0.409"/>
                  </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>From ANCOVA model with factors for treatment group, period and subject (random effect), and subject-level baseline and period-level baseline</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.27</ci_lower_limit>
            <ci_upper_limit>-0.15</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second-named treatment such that a negative difference favors the first named treatment</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks</title>
        <description>The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.</description>
        <time_frame>Baseline to 4 Weeks</time_frame>
        <population>ITT (Intent-to-treat) population was the primary analysis population, which included all the participants who were randomized and had at least one post-baseline efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product 1</title>
            <description>Participants brushed once (1.5g ± 0.05g of toothpaste containing 67 % sodium bicarbonate with 6 herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.</description>
          </group>
          <group group_id="O2">
            <title>Test Product 2</title>
            <description>Participants brushed once (1.5g ± 0.05g of toothpaste containing 67% sodium bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.</description>
          </group>
          <group group_id="O3">
            <title>Test Product 3</title>
            <description>Participants brushed once (1.5g ± 0.05g of whitening toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923ppm Sodium), under supervision of study staff for one timed minute.</description>
          </group>
          <group group_id="O4">
            <title>Test Product 4</title>
            <description>Participants brushed once (1.5g ± 0.05g of toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks</title>
          <description>The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.</description>
          <population>ITT (Intent-to-treat) population was the primary analysis population, which included all the participants who were randomized and had at least one post-baseline efficacy evaluation.</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="56"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.90" spread="0.308"/>
                    <measurement group_id="O2" value="2.92" spread="0.312"/>
                    <measurement group_id="O3" value="2.89" spread="0.304"/>
                    <measurement group_id="O4" value="2.86" spread="0.309"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.76" spread="0.514"/>
                    <measurement group_id="O2" value="1.78" spread="0.492"/>
                    <measurement group_id="O3" value="1.77" spread="0.469"/>
                    <measurement group_id="O4" value="1.96" spread="0.470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline after 4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.13" spread="0.430"/>
                    <measurement group_id="O2" value="-1.14" spread="0.426"/>
                    <measurement group_id="O3" value="-1.11" spread="0.419"/>
                    <measurement group_id="O4" value="-0.90" spread="0.409"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 15 days (from Screening Visit to 5 days following last visit [Visit 4])</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Product 1</title>
          <description>Participants brushed once (1.5g ± 0.05g of Toothpaste containing 67 % sodium bicarbonate with 6 herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.</description>
        </group>
        <group group_id="E2">
          <title>Test Product 2</title>
          <description>Participants brushed once (1.5g ± 0.05g of toothpaste containing 67% sodium bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.</description>
        </group>
        <group group_id="E3">
          <title>Test Product 3</title>
          <description>Participants brushed once (1.5g ± 0.05g of whitening toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923ppm Sodium), under supervision of study staff for one timed minute.</description>
        </group>
        <group group_id="E4">
          <title>Test Product 4</title>
          <description>Participants brushed once (1.5g ± 0.05g of toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one 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="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </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="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </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/NCT03285984
org study id: 202655
nct id: NCT03285984
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate and compare the plaque removal efficacy of four
      experimental toothpastes following a single timed brushing. Prior to each treatment visit,
      participants will abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs),
      immediately preceding a pre-brushing dental plaque evaluation. Participants will then brush
      once under supervision for one timed minute with each dentifrice after which re-disclosing
      and a post-brushing plaque assessment will be carried out.
This study will be a single centre, randomized, controlled, examiner blind, four treatment,
      four period crossover design. At the screening visit, following provision of written informed
      consent, eligible participants will be provided with a washout toothpaste and toothbrush for
      use at home during the study and for at least 14 days prior to the first treatment visit.

      Participants will then be scheduled to attend the first of four treatment visits a minimum of
      14 days later. For each treatment visit, participants must abstain from oral hygiene for a
      period of 24 hours (+6hrs, -2hrs), immediately preceding the pre-brushing dental plaque
      evaluation. All the participants will undergo an oral soft tissue (OST) examination followed
      by disclosing and a dental plaque assessment.

      At the treatment visit 1 pre-brushing plaque assessment, those who develop a sufficient
      amount of plaque (Turesky mean score ≥ 2.00) will be randomized to study treatment.
      Participants will then brush once (1.5 grams [g] ± 0.05g of assigned toothpaste), under
      supervision of study staff for one timed minute, with one of the four test toothpastes after
      which re-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 commercial washout toothpaste. Participants will complete four
      treatment visits and will brush once with each of the four test toothpastes throughout the
      course of the study.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The randomization schedule will indicate the treatment order sequence. Each subject will complete all four treatment regimens, one treatment regimen in each of the four treatment periods. This randomization will use a Williams Square layout and be provided by the Biostatistics Department, GSKCH.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks
time frame: Baseline to 4 Weeks
description: The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.
measure: Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks
time frame: Baseline to 4 Weeks
description: The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.
arm group label: Test product 1
arm group type: Experimental
description: Participants will brush once (1.5g ± 0.05g of Test product 1), under supervision of study staff for one timed minute
arm group label: Test product 2
arm group type: Experimental
description: Participants will brush once (1.5g ± 0.05g of Test product 2), under supervision of study staff for one timed minute
arm group label: Test product 3
arm group type: Experimental
description: Participants will brush once (1.5g ± 0.05g of Test product 3), under supervision of study staff for one timed minute
arm group label: Test product 4
arm group type: Experimental
description: Participants will brush once (1.5g ± 0.05g of Test product 4), under supervision of study staff for one timed minute
intervention type: Other
intervention name: 67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride
description: Toothpaste containing 67 percent (%) Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride
arm group label: Test product 1
intervention type: Other
intervention name: 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride
description: Toothpaste containing 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride
arm group label: Test product 2
intervention type: Other
intervention name: 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium
description: Whitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium
arm group label: Test product 3
intervention type: Other
intervention name: 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride
description: Toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride
arm group label: Test product 4
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
responsible party type: Sponsor
mesh term: Dental Plaque
mesh term: Listerine
mesh term: Fluorides
mesh term: Sodium Fluoride
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 