<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/NCT02207907</url>
  </required_header>
  <id_info>
    <org_study_id>202192</org_study_id>
    <secondary_id>RH02433</secondary_id>
    <nct_id>NCT02207907</nct_id>
  </id_info>
  <brief_title>To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste</brief_title>
  <official_title>A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of this study will be to compare the Gingival Bleeding and Gingival&#xD;
      Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice&#xD;
      compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be&#xD;
      conducted at Silverstone Research Group. Participants will be recruited from their database&#xD;
      and by use of an external recruitment agency.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Gingival Bleeding Sites at 24 Weeks</measure>
    <time_frame>Baseline, 24 weeks</time_frame>
    <description>Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Gingival Index (MGI) at 24 Weeks</measure>
    <time_frame>Baseline, 24 weeks</time_frame>
    <description>The Modified Gingival Index (MGI) was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Gingival Bleeding Sites at 6 and 12 Weeks.</measure>
    <time_frame>Baseline, 6 and 12 weeks</time_frame>
    <description>Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Gingival Index (MGI) at 6 and 12 Weeks.</measure>
    <time_frame>Baseline, 6 and 12 weeks</time_frame>
    <description>MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding Index at 6, 12 and 24 Weeks</measure>
    <time_frame>Baseline, 6, 12 and 24 weeks</time_frame>
    <description>The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &amp;Amp; Hein Plaque Index at 6, 12 and 24 Weeks.</measure>
    <time_frame>Baseline, 6,12 and 24 weeks</time_frame>
    <description>The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">247</enrollment>
  <condition>Oral Hygiene</condition>
  <arm_group>
    <arm_group_label>Sodium bicarbonate plus sodium fluoride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium fluoride</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium bicarbonate plus sodium fluoride</intervention_name>
    <description>Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
    <arm_group_label>Sodium bicarbonate plus sodium fluoride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium fluoride</intervention_name>
    <description>Toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
    <arm_group_label>Sodium fluoride</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#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;
&#xD;
          -  A minimum of 20 permanent gradable teeth&#xD;
&#xD;
          -  Moderate gingivitis present at the screening visit in the opinion of the investigator&#xD;
&#xD;
          -  A total of 20 bleeding sites or greater at baseline visit&#xD;
&#xD;
          -  Positive response to bleeding on brushing present at the screening visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast feeding women&#xD;
&#xD;
          -  Tobacco chewers&#xD;
&#xD;
          -  Current or relevant history of any serious, severe or unstable physical or psychiatric&#xD;
             illness or any other medical condition (e.g. Diabetes Mellitus) that would make the&#xD;
             participant unlikely to fully complete the study or any that increases the risk to the&#xD;
             participants or undermines the data validity.&#xD;
&#xD;
          -  Recent history (within the last year) of alcohol or other substance abuse&#xD;
&#xD;
          -  Participants requiring prophylactic antibiotic treatment prior to dental therapy&#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;
          -  Have current active caries or any medical conditions which may directly influence&#xD;
             gingival bleeding&#xD;
&#xD;
          -  Use of concomitant or any systemic medication that, in the opinion of the&#xD;
             investigator, might interfere with the outcome of the study or have an effect on&#xD;
             gingival conditions within 14 days of gingival examinations&#xD;
&#xD;
          -  Excessive calculus present that interferes with the probing examination for Gingival&#xD;
             Bleeding Index&#xD;
&#xD;
          -  Participation in another clinical study or receipt of an investigational drug or oral&#xD;
             care product within 30 days of the screening visit&#xD;
&#xD;
          -  An employee of the sponsor or the study site or members or 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>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <results_first_submitted>November 2, 2015</results_first_submitted>
  <results_first_submitted_qc>December 27, 2016</results_first_submitted_qc>
  <results_first_posted type="Actual">February 17, 2017</results_first_posted>
  <last_update_submitted>March 16, 2017</last_update_submitted>
  <last_update_submitted_qc>March 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>The participants were recruited at a clinical site in the USA.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Sodium Bicarbonate Dentrifice</title>
          <description>Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
        </group>
        <group group_id="P2">
          <title>0% Sodium Bicarbonate Dentrifice</title>
          <description>Toothpaste containing 1100 ppm fluoride as 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="124"/>
                <participants group_id="P2" count="123"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="113"/>
                <participants group_id="P2" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not meet study criteria</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sodium Bicarbonate Dentrifice</title>
          <description>Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
        </group>
        <group group_id="B2">
          <title>0% Sodium Bicarbonate Dentrifice</title>
          <description>Toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="124"/>
            <count group_id="B2" value="123"/>
            <count group_id="B3" value="247"/>
          </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="34.52" spread="13.162"/>
                    <measurement group_id="B2" value="37.55" spread="13.977"/>
                    <measurement group_id="B3" value="36.03" spread="13.631"/>
                  </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="69"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="141"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Gingival Bleeding Sites at 24 Weeks</title>
        <description>Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.</description>
        <time_frame>Baseline, 24 weeks</time_frame>
        <population>Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Bicarbonate Dentrifice</title>
            <description>Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
          </group>
          <group group_id="O2">
            <title>0% Sodium Bicarbonate Dentrifice</title>
            <description>Toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Gingival Bleeding Sites at 24 Weeks</title>
          <description>Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.</description>
          <population>Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.</population>
          <units>number of gingival bleeding sites</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of Bleeding Sites at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.13" spread="1.393"/>
                    <measurement group_id="O2" value="45.84" spread="1.448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Bleeding sites after 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.67" spread="1.142"/>
                    <measurement group_id="O2" value="36.39" spread="1.510"/>
                  </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 or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-17.491</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.317</ci_lower_limit>
            <ci_upper_limit>-14.664</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>Primary</type>
        <title>Modified Gingival Index (MGI) at 24 Weeks</title>
        <description>The Modified Gingival Index (MGI) was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration</description>
        <time_frame>Baseline, 24 weeks</time_frame>
        <population>Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Bicarbonate Dentrifice</title>
            <description>Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
          </group>
          <group group_id="O2">
            <title>0% Sodium Bicarbonate Dentrifice</title>
            <description>Toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Gingival Index (MGI) at 24 Weeks</title>
          <description>The Modified Gingival Index (MGI) was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration</description>
          <population>Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Modified Gingival Index at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.53" spread="0.017"/>
                    <measurement group_id="O2" value="2.54" spread="0.018"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Modified Gingival Index after 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.23" spread="0.021"/>
                    <measurement group_id="O2" value="2.43" spread="0.210"/>
                  </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 or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.201</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.237</ci_lower_limit>
            <ci_upper_limit>-0.165</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>Number of Gingival Bleeding Sites at 6 and 12 Weeks.</title>
        <description>Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.</description>
        <time_frame>Baseline, 6 and 12 weeks</time_frame>
        <population>Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Bicarbonate Dentrifice</title>
            <description>Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
          </group>
          <group group_id="O2">
            <title>0% Sodium Bicarbonate</title>
            <description>Toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Gingival Bleeding Sites at 6 and 12 Weeks.</title>
          <description>Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.</description>
          <population>Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement</population>
          <units>number of gingival bleeding sites</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of Bleeding Sites at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.13" spread="1.393"/>
                    <measurement group_id="O2" value="45.84" spread="1.448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Bleeding Sites after 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.40" spread="0.999"/>
                    <measurement group_id="O2" value="40.27" spread="1.448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Bleeding sites after 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.83" spread="0.915"/>
                    <measurement group_id="O2" value="34.23" spread="1.260"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Modified Gingival Index (MGI) at 6 and 12 Weeks.</title>
        <description>MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration</description>
        <time_frame>Baseline, 6 and 12 weeks</time_frame>
        <population>Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Bicarbonate Dentrifice</title>
            <description>Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
          </group>
          <group group_id="O2">
            <title>0% Sodium Bicarbonate Dentrifice</title>
            <description>Toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Gingival Index (MGI) at 6 and 12 Weeks.</title>
          <description>MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration</description>
          <population>Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Modified Gingival Index at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.53" spread="0.017"/>
                    <measurement group_id="O2" value="2.54" spread="0.018"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Modified Gingival Index after 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.28" spread="0.017"/>
                    <measurement group_id="O2" value="2.45" spread="0.018"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Modified Gingival Index after 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.24" spread="0.018"/>
                    <measurement group_id="O2" value="2.40" spread="0.018"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bleeding Index at 6, 12 and 24 Weeks</title>
        <description>The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed</description>
        <time_frame>Baseline, 6, 12 and 24 weeks</time_frame>
        <population>Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Bicarbonate Dentrifice</title>
            <description>Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
          </group>
          <group group_id="O2">
            <title>0% Sodium Bicarbonate Dentrifice</title>
            <description>Toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
        </group_list>
        <measure>
          <title>Bleeding Index at 6, 12 and 24 Weeks</title>
          <description>The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed</description>
          <population>Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bleeding Index Score at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.45" spread="0.014"/>
                    <measurement group_id="O2" value="0.47" spread="0.014"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bleeding Index Score after 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="0.010"/>
                    <measurement group_id="O2" value="0.41" spread="0.014"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bleeding Index Score after 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="0.009"/>
                    <measurement group_id="O2" value="0.35" spread="0.012"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bleeding Index Score after 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.012"/>
                    <measurement group_id="O2" value="0.37" spread="0.014"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &amp;Amp; Hein Plaque Index at 6, 12 and 24 Weeks.</title>
        <description>The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth</description>
        <time_frame>Baseline, 6,12 and 24 weeks</time_frame>
        <population>Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Bicarbonate Dentrifice</title>
            <description>Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
          </group>
          <group group_id="O2">
            <title>0% Sodium Bicarbonate Dentrifice</title>
            <description>Toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
        </group_list>
        <measure>
          <title>Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &amp;Amp; Hein Plaque Index at 6, 12 and 24 Weeks.</title>
          <description>The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth</description>
          <population>Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall Plaque Score at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.04" spread="0.019"/>
                    <measurement group_id="O2" value="3.00" spread="0.019"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Plaque Score after 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.65" spread="0.030"/>
                    <measurement group_id="O2" value="2.98" spread="0.021"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Plaque Score after 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.55" spread="0.029"/>
                    <measurement group_id="O2" value="2.92" spread="0.025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Plaque Score after 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.52" spread="0.032"/>
                    <measurement group_id="O2" value="2.95" spread="0.020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interproximal Plaque Score at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.12" spread="0.019"/>
                    <measurement group_id="O2" value="3.08" spread="0.018"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interproximal Plaque Score after 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.73" spread="0.029"/>
                    <measurement group_id="O2" value="3.05" spread="0.020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interproximal Plaque Score after 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.64" spread="0.028"/>
                    <measurement group_id="O2" value="3.01" spread="0.022"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interproximal Plaque Score after 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.61" spread="0.031"/>
                    <measurement group_id="O2" value="3.03" spread="0.019"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Sodium Bicarbonate Dentrifice</title>
          <description>Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
        </group>
        <group group_id="E2">
          <title>0% Sodium Bicarbonate Dentrifice</title>
          <description>Toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="123"/>
              </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="7" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>GINGIVAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>SENSITIVITY OF TEETH</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>MOUTH INJURY</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>PROCEDURAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>THERMAL BURN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>OVARIAN CYST RUPTURED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="123"/>
              </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>
    </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/NCT02207907
org study id: 202192
secondary id: RH02433
nct id: NCT02207907
lead sponsor: 
has dmc: No
The primary objectives of this study will be to compare the Gingival Bleeding and Gingival
      Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice
      compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be
      conducted at Silverstone Research Group. Participants will be recruited from their database
      and by use of an external recruitment agency.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Number of Gingival Bleeding Sites at 24 Weeks
time frame: Baseline, 24 weeks
description: Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.
measure: Modified Gingival Index (MGI) at 24 Weeks
time frame: Baseline, 24 weeks
description: The Modified Gingival Index (MGI) was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration
measure: Number of Gingival Bleeding Sites at 6 and 12 Weeks.
time frame: Baseline, 6 and 12 weeks
description: Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.
measure: Modified Gingival Index (MGI) at 6 and 12 Weeks.
time frame: Baseline, 6 and 12 weeks
description: MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration
measure: Bleeding Index at 6, 12 and 24 Weeks
time frame: Baseline, 6, 12 and 24 weeks
description: The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
measure: Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
time frame: Baseline, 6,12 and 24 weeks
description: The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth
arm group label: Sodium bicarbonate plus sodium fluoride
arm group type: Experimental
description: Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
arm group label: Sodium fluoride
arm group type: Active Comparator
description: Toothpaste containing 1100 ppm fluoride as sodium fluoride
intervention type: Drug
intervention name: Sodium bicarbonate plus sodium fluoride
description: Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
arm group label: Sodium bicarbonate plus sodium fluoride
intervention type: Drug
intervention name: Sodium fluoride
description: Toothpaste containing 1100 ppm fluoride as sodium fluoride
arm group label: Sodium fluoride
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: United States
responsible party type: Sponsor
mesh term: Listerine
mesh term: Fluorides
mesh term: Sodium Fluoride
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 