<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/NCT02992691</url>
  </required_header>
  <id_info>
    <org_study_id>206886</org_study_id>
    <nct_id>NCT02992691</nct_id>
  </id_info>
  <brief_title>Efficacy of Three Experimental Toothpastes to Remove Plaque</brief_title>
  <official_title>Dose Response of Three Experimental Dentifrices in Plaque Removal in a Single Brushing Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      The Dose response of three experimental toothpastes (test product 1, test product 2 and test&#xD;
      product 3) to remove plaque after a single brushing, compared to a positive control and&#xD;
      negative control dentifrice will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single centre, controlled, examiner blind, five treatment, five period,&#xD;
      crossover design study in healthy participants. This study will evaluate the dose response of&#xD;
      three experimental toothpastes (test product 1, test product 2 and test product 3) to remove&#xD;
      plaque after a single brushing, compared to a positive control and negative control&#xD;
      dentifrice. Plaque removal efficacy will be measured by Turesky modification of Quigley Hein&#xD;
      Plaque Index (TPI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2016</start_date>
  <completion_date type="Actual">February 2, 2017</completion_date>
  <primary_completion_date type="Actual">February 2, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (TPI), Positive Control Versus [vs.] Negative Control</measure>
    <time_frame>Up to 5 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>Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test Product 1, 2 and 3 vs Negative Control)</measure>
    <time_frame>Up to 5 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>
  <secondary_outcome>
    <measure>Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test Product 1, 2 and 3 vs Positive Control)</measure>
    <time_frame>Up to 5 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>5</number_of_arms>
  <enrollment type="Actual">75</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 be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once 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 be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once 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 be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Positive Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>20% w/w sodium bicarbonate</intervention_name>
    <description>Dentifrice containing 20% w/w sodium bicarbonate.</description>
    <arm_group_label>Test Product 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>35% w/w sodium bicarbonate</intervention_name>
    <description>Dentifrice containing 35% w/w sodium bicarbonate.</description>
    <arm_group_label>Test Product 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>50% w/w sodium bicarbonate</intervention_name>
    <description>Dentifrice containing 20% w/w sodium bicarbonate.</description>
    <arm_group_label>Test Product 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>67% w/w sodium bicarbonate</intervention_name>
    <description>Dentifrice containing 67% w/w sodium bicarbonate.</description>
    <arm_group_label>Positive Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0% w/w sodium bicarbonate</intervention_name>
    <description>Dentifrice containing 0% sodium bicarbonate and 1450 parts per million (ppm) fluoride.</description>
    <arm_group_label>Negative Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Demonstrates understanding of the study procedures, restrictions and willingness to&#xD;
             participate as evidenced by voluntary written informed consent and has received a&#xD;
             signed and dated copy of the informed consent form.&#xD;
&#xD;
          -  Aged between 18- 65 years&#xD;
&#xD;
          -  Good general health with (in the opinion of the investigator) no clinically&#xD;
             significant and relevant abnormalities of medical history or oral/dental examination.&#xD;
             Absence of any condition that would impact on the participant's safety or wellbeing or&#xD;
             affect the individual's ability to understand and follow study procedures and&#xD;
             requirements.&#xD;
&#xD;
          -  Good dental health based on medical history and oral soft tissue examination at&#xD;
             screening, a minimum of 20 permanent gradable teeth (Gradable teeth are those where&#xD;
             restorative materials cover less than 25% of the tooth surface to be graded), and mean&#xD;
             Turesky plaque score of ≥ 2.00 at Visit 1 and Visit 2 (pre-brushing plaque&#xD;
             assessment).&#xD;
&#xD;
          -  Understands and is willing, able and likely to comply with all study procedures and&#xD;
             restrictions.&#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;
          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely&#xD;
             related compounds) or any of their stated ingredients.&#xD;
&#xD;
          -  Participation in another clinical study: cosmetic studies within 14 days of the&#xD;
             screening visit or receipt of an investigational drug within 30 days of the screening&#xD;
             visit and previous participation in this study.&#xD;
&#xD;
          -  Recent history (within the last year) of alcohol or other substance abuse.&#xD;
&#xD;
          -  An employee of the sponsor or the study site or members of their immediate family and&#xD;
             an employee of any toothpaste manufacturer or their immediate family.&#xD;
&#xD;
          -  Antibiotic treatment within 14 days prior to Visit 2 or throughout the study, any&#xD;
             other treatment that would interfere with the study outcomes, at the discretion of the&#xD;
             examiner or investigator.&#xD;
&#xD;
          -  High levels of extrinsic stain or calculus deposits which might interfere with plaque&#xD;
             assessments at the discretion of the investigator, dental conditions / disease&#xD;
             requiring immediate treatment, pre-existing sensitivity to oral care products, severe&#xD;
             gingivitis that may, in the opinion of the investigator, compromise the study or the&#xD;
             oral health of the participants if they participate in the study, presence of&#xD;
             orthodontic bands or appliances, extensive crowns, partial dentures, or fixed&#xD;
             retainers on the maxillary or mandibular teeth, active carious lesions needing&#xD;
             immediate care, oral lesions/manifestations that would impact on the outcome of the&#xD;
             study, presence of oral or peri-oral ulceration including herpetic lesions at the time&#xD;
             of screening, have current active caries or periodontitis that may, in the opinion of&#xD;
             the investigator, compromise the study or the oral health of the participants if they&#xD;
             participate in the study, restorations in a poor state of repair that may, in the&#xD;
             opinion of the investigator, compromise the study or the oral health of the&#xD;
             participants if they participate in the study, use of a chlorhexidine mouthwash within&#xD;
             14 days of Visit 2 or through the study and current use of Listerine, Corsodyl or any&#xD;
             antimicrobial mouth rinse or throughout the study.&#xD;
&#xD;
          -  Participant unwilling to abstain from using chewing tobacco (with or without tobacco)&#xD;
             and Participant unwilling to abstain from smoking tobacco or E-cigarettes for 4 hours&#xD;
             prior to all visits and until all dental assessments are completed at each visit.&#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>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Schenefeld</city>
        <state>Schleswig-Holstein</state>
        <zip>22869</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217381&amp;amp;parentIdentifier=206886&amp;amp;attachmentIdentifier=b79c83c9-8d09-4165-888d-5b5838a48e61&amp;amp;fileName=gsk-206886-clinical-study-report-redact.pdf&amp;amp;versionIdentifier=</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Dose+Response+of+Three+Experimental+Dentifrices+in+Plaque+Removal+in+a+Single+Brushing+Model</url>
    <description>Randomized Clinical Dose-Response Study to Evaluate Plaque Removal by Three Experimental Sodium Bicarbonate Toothpastes Using a Single Brushing Model.</description>
  </link>
  <results_reference>
    <citation>Jose A, Parkinson CR, Manger C, Bielfeldt S, Krause C. Randomized Clinical Dose-Response Study to Evaluate Plaque Removal by Three Experimental Sodium Bicarbonate Toothpastes Using a Single Brushing Model. J Clin Dent. 2018 Dec;29(4):75-80.</citation>
    <PMID>30942962</PMID>
  </results_reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 11, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <results_first_submitted>March 9, 2018</results_first_submitted>
  <results_first_submitted_qc>October 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 29, 2018</results_first_posted>
  <last_update_submitted>May 15, 2019</last_update_submitted>
  <last_update_submitted_qc>May 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2019</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>
  <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>January 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT02992691/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>January 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT02992691/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited at one center in Germany</recruitment_details>
      <pre_assignment_details>A total of 100 participants were screened, out of which 25 participants were screening failure. Remaining 75 participants were enrolled in the study. Out of 75 enrolled participants, 6 did not meet eligibility criteria, 3 withdrew their consent, 10 participants, due to other reason (not specified). Remaining 56 were randomized in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Overall Study</title>
          <description>This was a single-center, controlled, examiner-blind, five-treatment, five-period, crossover design study in healthy volunteers. Each participant received Test Product 1 (Dentifrice containing 20 percent [%] weight by weight [w/w] sodium bicarbonate), Test product 2 (Dentifrice containing 35% w/w sodium bicarbonate) Test product 3 (Dentifrice containing 50% w/w sodium bicarbonate), positive control (Dentifrice containing 67% w/w sodium bicarbonate) and negative control (Dentifrice containing 0% sodium bicarbonate and 1450 parts per million (ppm) 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="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Test Product 2</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Test Product 3</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Positive Control</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Negative Control</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Overall Study</title>
          <description>This was five-treatment, five-period, crossover design study. Each participant received Test Product 1 (Dentifrice containing 20 percent [%] weight by weight [w/w] sodium bicarbonate), Test product 2 (Dentifrice containing 35% w/w sodium bicarbonate) Test product 3 (Dentifrice containing 50% w/w sodium bicarbonate), positive control (Dentifrice containing 67% w/w sodium bicarbonate) and negative control (Dentifrice containing 0% sodium bicarbonate and 1450 parts per million [ppm] fluoride).</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="42.3" spread="10.59"/>
                  </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="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                  </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>Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (TPI), Positive Control Versus [vs.] Negative Control</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>Up to 5 weeks</time_frame>
        <population>Intent to treat (ITT) population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Control</title>
            <description>Participant applied a full ribbon of dentifrice containing 67% w/w sodium bicarbonate and brushed their teeth for one timed minute.</description>
          </group>
          <group group_id="O2">
            <title>Negative Control</title>
            <description>Participant applied a full ribbon of dentifrice containing 0% sodium bicarbonate and 1450 ppm fluoride and brushed their teeth for one timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (TPI), Positive Control Versus [vs.] Negative Control</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>Intent to treat (ITT) population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.</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="55"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.57" spread="0.247"/>
                    <measurement group_id="O2" value="-0.54" spread="0.253"/>
                  </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>
            <groups_desc>This comparison was tested under a null hypothesis of no difference against alternative hypothesis of a difference between treatments</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6674</p_value>
            <p_value_desc>From ANCOVA analysis for change from pre-brushing with treatment and period as fixed effect, participant as random effect, participant-level baseline and period level minus participant-level baseline as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.01</param_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>0.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test Product 1, 2 and 3 vs Negative Control)</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>Up to 5 weeks</time_frame>
        <population>ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product 1</title>
            <description>Participant applied a full ribbon of dentifrice containing 20% w/w sodium bicarbonate and brushed their teeth for one timed minute.</description>
          </group>
          <group group_id="O2">
            <title>Test Product 2</title>
            <description>Participant applied a full ribbon of dentifrice containing 35% w/w sodium bicarbonate and brushed their teeth for one timed minute.</description>
          </group>
          <group group_id="O3">
            <title>Test Product 3</title>
            <description>Participant applied a full ribbon of dentifrice containing 50% w/w sodium bicarbonate and brushed their teeth for one timed minute.</description>
          </group>
          <group group_id="O4">
            <title>Negative Control</title>
            <description>Participant applied a full ribbon of dentifrice containing 0% w/w sodium bicarbonate and 1450 ppm fluoride brushed their teeth for one timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test Product 1, 2 and 3 vs Negative Control)</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 population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.</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="55"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="0.250"/>
                    <measurement group_id="O2" value="-0.55" spread="0.231"/>
                    <measurement group_id="O3" value="-0.55" spread="0.243"/>
                    <measurement group_id="O4" value="-0.54" spread="0.253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test Product 1, 2 and 3 vs Positive Control)</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>Up to 5 weeks</time_frame>
        <population>ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product 1</title>
            <description>Participant applied a full ribbon of dentifrice containing 20% w/w sodium bicarbonate and brushed their teeth for one timed minute.</description>
          </group>
          <group group_id="O2">
            <title>Test Product 2</title>
            <description>Participant applied a full ribbon of dentifrice containing 35% w/w sodium bicarbonate and brushed their teeth for one timed minute..</description>
          </group>
          <group group_id="O3">
            <title>Test Product 3</title>
            <description>Participant applied a full ribbon of dentifrice containing 50% w/w sodium bicarbonate and brushed their teeth for one timed minute.</description>
          </group>
          <group group_id="O4">
            <title>Positive Control</title>
            <description>Participant applied a full ribbon of dentifrice containing 67% w/w sodium bicarbonate and brushed their teeth for one timed minute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test Product 1, 2 and 3 vs Positive Control)</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 population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.</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="55"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="0.250"/>
                    <measurement group_id="O2" value="-0.55" spread="0.231"/>
                    <measurement group_id="O3" value="-0.55" spread="0.243"/>
                    <measurement group_id="O4" value="-0.57" spread="0.247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 5 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Product 1</title>
          <description>Participant applied a full ribbon of dentifrice containing 20% w/w sodium bicarbonate and brushed their teeth for one timed minute.</description>
        </group>
        <group group_id="E2">
          <title>Test Product 2</title>
          <description>Participant applied a full ribbon of dentifrice containing 35% w/w sodium bicarbonate and brushed their teeth for one timed minute.</description>
        </group>
        <group group_id="E3">
          <title>Test Product 3</title>
          <description>Participant applied a full ribbon of dentifrice containing 50% w/w sodium bicarbonate and brushed their teeth for one timed minute.</description>
        </group>
        <group group_id="E4">
          <title>Positive Control</title>
          <description>Participant applied a full ribbon of dentifrice containing 67% w/w sodium bicarbonate and brushed their teeth for one timed minute.</description>
        </group>
        <group group_id="E5">
          <title>Negative Control</title>
          <description>Participant applied a full ribbon of dentifrice containing 0% w/w sodium bicarbonate and 1450 ppm fluoride brushed their teeth for one timed minute.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gingival Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Oral Mucosal Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Tongue Coated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Oral Herpes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Angular Cheilitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pulpitis Dental</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pharyngeal Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Tonsillar Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
              </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/NCT02992691
org study id: 206886
nct id: NCT02992691
lead sponsor: 
The Dose response of three experimental toothpastes (test product 1, test product 2 and test
      product 3) to remove plaque after a single brushing, compared to a positive control and
      negative control dentifrice will be evaluated.
This will be a single centre, controlled, examiner blind, five treatment, five period,
      crossover design study in healthy participants. This study will evaluate the dose response of
      three experimental toothpastes (test product 1, test product 2 and test product 3) to remove
      plaque after a single brushing, compared to a positive control and negative control
      dentifrice. Plaque removal efficacy will be measured by Turesky modification of Quigley Hein
      Plaque Index (TPI).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (TPI), Positive Control Versus [vs.] Negative Control
time frame: Up to 5 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: Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test Product 1, 2 and 3 vs Negative Control)
time frame: Up to 5 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.
measure: Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test Product 1, 2 and 3 vs Positive Control)
time frame: Up to 5 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 be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.
arm group label: Test Product 2
arm group type: Experimental
description: Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.
arm group label: Test Product 3
arm group type: Experimental
description: Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.
arm group label: Positive Control
arm group type: Active Comparator
description: Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.
arm group label: Negative Control
arm group type: Other
description: Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.
intervention type: Drug
intervention name: 20% w/w sodium bicarbonate
description: Dentifrice containing 20% w/w sodium bicarbonate.
arm group label: Test Product 1
intervention type: Drug
intervention name: 35% w/w sodium bicarbonate
description: Dentifrice containing 35% w/w sodium bicarbonate.
arm group label: Test Product 2
intervention type: Drug
intervention name: 50% w/w sodium bicarbonate
description: Dentifrice containing 20% w/w sodium bicarbonate.
arm group label: Test Product 3
intervention type: Drug
intervention name: 67% w/w sodium bicarbonate
description: Dentifrice containing 67% w/w sodium bicarbonate.
arm group label: Positive Control
intervention type: Drug
intervention name: 0% w/w sodium bicarbonate
description: Dentifrice containing 0% sodium bicarbonate and 1450 parts per million (ppm) fluoride.
arm group label: Negative Control
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
facility: 
country: Germany
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217381&amp;parentIdentifier=206886&amp;attachmentIdentifier=b79c83c9-8d09-4165-888d-5b5838a48e61&amp;fileName=gsk-206886-clinical-study-report-redact.pdf&amp;versionIdentifier=
description: Related Info
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Dose+Response+of+Three+Experimental+Dentifrices+in+Plaque+Removal+in+a+Single+Brushing+Model
description: Randomized Clinical Dose-Response Study to Evaluate Plaque Removal by Three Experimental Sodium Bicarbonate Toothpastes Using a Single Brushing Model.
citation: Jose A, Parkinson CR, Manger C, Bielfeldt S, Krause C. Randomized Clinical Dose-Response Study to Evaluate Plaque Removal by Three Experimental Sodium Bicarbonate Toothpastes Using a Single Brushing Model. J Clin Dent. 2018 Dec;29(4):75-80.
PMID: 30942962
responsible party type: Sponsor
mesh term: Dental Plaque
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 