<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/NCT02207400</url>
  </required_header>
  <id_info>
    <org_study_id>202193</org_study_id>
    <secondary_id>RH02434</secondary_id>
    <nct_id>NCT02207400</nct_id>
  </id_info>
  <brief_title>To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms</brief_title>
  <official_title>A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms</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>
      This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily&#xD;
      use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate&#xD;
      toothpaste after 24 weeks of use. The study will be conducted at Salus Research, Inc.&#xD;
      Participants will be recruited from their database and by use of an external recruitment&#xD;
      agency&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a single-centre, examiner blind, two treatment, parallel group, stratified&#xD;
      (by baseline number of bleeding sites smoking status and bacterial sampling) randomized&#xD;
      clinical study. At the screening visit, following provision of written informed consent,&#xD;
      eligible participants will be provided with a standard toothpaste and toothbrush for brushing&#xD;
      once in at the clinic and for approximately one week use at home until the baseline visit.&#xD;
      Participants will be asked to abstain from brushing over a 12 hour period prior to the&#xD;
      Baseline visit. At the baseline visit an oral soft tissue (OST) assessment, Modified Gingival&#xD;
      Index (MGI) and Bleeding Index (BI), and then dental plaque assessment will be performed.&#xD;
      Participants will be stratified according to their baseline number of bleeding sites, smoking&#xD;
      status and whether selected for bacterial sampling. Participants will be then randomized into&#xD;
      one of two treatment groups. After using, their assigned treatment twice daily at home for 6&#xD;
      weeks (visit 3), 12 weeks (visit 4) and 24 weeks (visit 5), participants will return to the&#xD;
      site with overnight plaque at approximately the same time of day as the Baseline visit if&#xD;
      possible. Participants will undergo a full OST examination and the recording of any Adverse&#xD;
      Events (AEs). Participants will then undergo MGI, BI followed by dental plaque assessment.&#xD;
      Microbiological samples will be collected on a subset of 50 participants (Determined by first&#xD;
      50 participants randomized).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2014</start_date>
  <completion_date type="Actual">April 30, 2015</completion_date>
  <primary_completion_date type="Actual">February 1, 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>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 used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Gingival Index (MGI) at 24 Weeks</measure>
    <time_frame>24 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>
  </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>BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system 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>Modified Gingival Index (MGI)) at 6 and 12 Weeks.</measure>
    <time_frame>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 (BI) at 6, 12 and 24 Weeks</measure>
    <time_frame>6, 12 and 24 weeks</time_frame>
    <description>BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system 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) at 6, 12 and 24 Weeks.</measure>
    <time_frame>6, 12 and 24 weeks</time_frame>
    <description>The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 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 than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks</measure>
    <time_frame>Baseline, 6, 12, 24 and 32 weeks</time_frame>
    <description>Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">246</enrollment>
  <condition>Oral Hygiene</condition>
  <arm_group>
    <arm_group_label>Experimental Dentifrice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were advised to brush their teeth with experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference Dentifrice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants were advised to brush their teeth with reference dentifrice containing 1100ppm fluoride as sodium fluoride</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium bicarbonate and sodium fluoride</intervention_name>
    <description>Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
    <arm_group_label>Experimental Dentifrice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium fluoride</intervention_name>
    <description>Comparator toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
    <arm_group_label>Reference Dentifrice</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;
             participant 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>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>July 21, 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>December 21, 2015</results_first_submitted>
  <results_first_submitted_qc>June 13, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 26, 2016</results_first_posted>
  <last_update_submitted>July 26, 2018</last_update_submitted>
  <last_update_submitted_qc>July 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2018</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 and Sodium Fluoride Dentifrice</title>
          <description>Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
        </group>
        <group group_id="P2">
          <title>Sodium Fluoride Dentifrice</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="123"/>
                <participants group_id="P2" count="123"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
                <participants group_id="P2" count="109"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <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="8"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Positive Urine Pregnancy Test</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 and Sodium Fluoride Dentifrice</title>
          <description>Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
        </group>
        <group group_id="B2">
          <title>Sodium Fluoride Dentifrice</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="123"/>
            <count group_id="B2" value="123"/>
            <count group_id="B3" value="246"/>
          </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="39.39" spread="14.284"/>
                    <measurement group_id="B2" value="37.77" spread="12.615"/>
                    <measurement group_id="B3" value="38.58" spread="13.473"/>
                  </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="74"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="152"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="94"/>
                  </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>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 used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed</description>
        <time_frame>24 weeks</time_frame>
        <population>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Bicarbonate and Sodium Fluoride Dentifrice</title>
            <description>Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride</description>
          </group>
          <group group_id="O2">
            <title>Sodium Fluoride Dentifrice</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>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 used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed</description>
          <population>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
          <units>Number of bleeding sites</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.24" spread="7.663"/>
                    <measurement group_id="O2" value="24.90" spread="9.044"/>
                  </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>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-11.612</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.191</ci_lower_limit>
            <ci_upper_limit>-10.033</ci_upper_limit>
            <estimate_desc>Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice 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>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>24 weeks</time_frame>
        <population>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Bicarbonate and Sodium Fluoride Dentifrice</title>
            <description>Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride</description>
          </group>
          <group group_id="O2">
            <title>Sodium Fluoride Dentifrice</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>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>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
          <units>Units 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="118"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.26" spread="0.505"/>
                    <measurement group_id="O2" value="1.93" spread="0.408"/>
                  </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>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-0.652</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.738</ci_lower_limit>
            <ci_upper_limit>-0.566</ci_upper_limit>
            <estimate_desc>Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice 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>BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system 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 and 12 weeks</time_frame>
        <population>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Bicarbonate and Sodium Fluoride Dentifrice</title>
            <description>Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride</description>
          </group>
          <group group_id="O2">
            <title>Sodium Fluoride Dentifrice</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>BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed</description>
          <population>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
          <units>Number of bleeding sites</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="117"/>
              </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="29.76" spread="8.238"/>
                    <measurement group_id="O2" value="29.05" spread="8.390"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Bleeding Sites at 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.26" spread="9.339"/>
                    <measurement group_id="O2" value="23.23" spread="10.993"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Bleeding Sites at 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.73" spread="7.632"/>
                    <measurement group_id="O2" value="23.86" spread="9.265"/>
                  </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>6 and 12 weeks</time_frame>
        <population>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Bicarbonate and Sodium Fluoride Dentifrice</title>
            <description>Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride</description>
          </group>
          <group group_id="O2">
            <title>Sodium Fluoride Dentifrice</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>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
          <units>Units 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="118"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MGI at 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" spread="0.567"/>
                    <measurement group_id="O2" value="1.96" spread="0.427"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MGI at 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" spread="0.536"/>
                    <measurement group_id="O2" value="1.94" spread="0.464"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bleeding Index (BI) at 6, 12 and 24 Weeks</title>
        <description>BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed</description>
        <time_frame>6, 12 and 24 weeks</time_frame>
        <population>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Bicarbonate and Sodium Fluoride Dentifrice</title>
            <description>Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride</description>
          </group>
          <group group_id="O2">
            <title>Sodium Fluoride Dentifrice</title>
            <description>Toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
        </group_list>
        <measure>
          <title>Bleeding Index (BI) at 6, 12 and 24 Weeks</title>
          <description>BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed</description>
          <population>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
          <units>Units 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="118"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BI Score Score at 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" spread="0.133"/>
                    <measurement group_id="O2" value="0.30" spread="0.172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BI Score Score at 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.112"/>
                    <measurement group_id="O2" value="0.28" spread="0.135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BI Score Score at 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.116"/>
                    <measurement group_id="O2" value="0.31" spread="0.159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.</title>
        <description>The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 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 than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.</description>
        <time_frame>6, 12 and 24 weeks</time_frame>
        <population>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Bicarbonate and Sodium Fluoride Dentifrice</title>
            <description>Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride</description>
          </group>
          <group group_id="O2">
            <title>Sodium Fluoride Dentifrice</title>
            <description>Toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
        </group_list>
        <measure>
          <title>Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.</title>
          <description>The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 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 than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.</description>
          <population>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
          <units>Units 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="118"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall Plaque Score at 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.56" spread="0.536"/>
                    <measurement group_id="O2" value="3.01" spread="0.411"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Plaque Score at 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.54" spread="0.495"/>
                    <measurement group_id="O2" value="2.90" spread="0.374"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Plaque Score at 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.47" spread="0.437"/>
                    <measurement group_id="O2" value="2.92" spread="0.399"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interproximal Plaque Score at 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.78" spread="0.492"/>
                    <measurement group_id="O2" value="3.19" spread="0.351"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interproximal Plaque Score at 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.76" spread="0.437"/>
                    <measurement group_id="O2" value="3.10" spread="0.311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interproximal Plaque Score at 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.71" spread="0.390"/>
                    <measurement group_id="O2" value="3.11" spread="0.336"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks</title>
        <description>Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours).</description>
        <time_frame>Baseline, 6, 12, 24 and 32 weeks</time_frame>
        <population>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Bicarbonate and Sodium Fluoride Dentifrice</title>
            <description>Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm)fluoride as sodium fluoride</description>
          </group>
          <group group_id="O2">
            <title>Sodium Fluoride Dentifrice</title>
            <description>Toothpaste containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
        </group_list>
        <measure>
          <title>Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks</title>
          <description>Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours).</description>
          <population>ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.</population>
          <units>colony forming units per sample</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Staph Count at Baseline (n=24, 26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.82"/>
                    <measurement group_id="O2" value="0.2" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Steph Count at 6 weeks (n=24, 26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.34"/>
                    <measurement group_id="O2" value="0" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Steph Count at 12 weeks (n=24, 26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="7.10"/>
                    <measurement group_id="O2" value="3.2" spread="15.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Steph Count at 24 weeks (n=23, 25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.59"/>
                    <measurement group_id="O2" value="0.2" spread="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Steph Count at 32 weeks (n=21, 21)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.51"/>
                    <measurement group_id="O2" value="0.1" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yeast Count at Baseline (n=24, 26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="203.4" spread="842.28"/>
                    <measurement group_id="O2" value="647.8" spread="2958.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yeast Count at 6 weeks (n=23, 26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="287.3" spread="1014.31"/>
                    <measurement group_id="O2" value="784.3" spread="1796.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yeast Count at 12 weeks (n=24, 25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="668.9" spread="812.81"/>
                    <measurement group_id="O2" value="411.3" spread="906.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yeast Count at 24 weeks (n=17, 22)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1479.6" spread="1165.48"/>
                    <measurement group_id="O2" value="1522.3" spread="1008.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yeast Count at 32 weeks (n= 14, 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2743.5" spread="2505.75"/>
                    <measurement group_id="O2" value="1206.4" spread="1008.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coliform count at Baseline (n= 24, 26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="8.82"/>
                    <measurement group_id="O2" value="3.8" spread="8.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coliform count at 6 weeks (n= 24, 26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="6.72"/>
                    <measurement group_id="O2" value="5.7" spread="20.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coliform count at 12 weeks (n= 24, 26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" spread="14.65"/>
                    <measurement group_id="O2" value="26.9" spread="78.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coliform count at 24 weeks (n=23, 25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" spread="16.86"/>
                    <measurement group_id="O2" value="12.6" spread="19.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coliform count at 32 weeks (n=21, 21)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" spread="16.17"/>
                    <measurement group_id="O2" value="17.8" spread="29.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>E. Coli count at Baseline (n=24, 26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>E. Coli count at 6 weeks (n=24, 26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.28"/>
                    <measurement group_id="O2" value="0" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>E. Coli count at 12 weeks (n=24, 26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.28"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>E. Coli count at 24 weeks (n=23, 25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.25"/>
                    <measurement group_id="O2" value="0.2" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>E. Coli count at 32 weeks (n=21, 21)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.29"/>
                    <measurement group_id="O2" value="0" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sodium Bicarbonate and Sodium Fluoride Dentifrice</title>
          <description>Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride</description>
        </group>
        <group group_id="E2">
          <title>Sodium Fluoride Dentifrice</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="123"/>
                <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>
        <default_vocab>MedDRA 10.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>HYPOTHYROIDISM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>CHEILITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>SENSITIVITY OF TEETH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>APHTHOUS STOMATITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>GINGIVAL ULCERATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>MOUTH ULCERATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>TONGUE ULCERATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis Orbital</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>PHARYNGITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>PHARYNGITIS STREPTOCOCCAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>PULPITIS DENTAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCAL INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>TOOTH ABSCESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS VIRAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" 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" events="4" subjects_affected="4" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>TRAUMATIC ULCER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>ARTHROPOD BITE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>THERMAL BURN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>BURNING SENSATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>PULMONARY CONGESTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>INGROWING NAIL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" events="0" 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/NCT02207400
org study id: 202193
secondary id: RH02434
nct id: NCT02207400
lead sponsor: 
has dmc: No
This study will 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 Salus Research, Inc.
      Participants will be recruited from their database and by use of an external recruitment
      agency
This study will be a single-centre, examiner blind, two treatment, parallel group, stratified
      (by baseline number of bleeding sites smoking status and bacterial sampling) randomized
      clinical study. At the screening visit, following provision of written informed consent,
      eligible participants will be provided with a standard toothpaste and toothbrush for brushing
      once in at the clinic and for approximately one week use at home until the baseline visit.
      Participants will be asked to abstain from brushing over a 12 hour period prior to the
      Baseline visit. At the baseline visit an oral soft tissue (OST) assessment, Modified Gingival
      Index (MGI) and Bleeding Index (BI), and then dental plaque assessment will be performed.
      Participants will be stratified according to their baseline number of bleeding sites, smoking
      status and whether selected for bacterial sampling. Participants will be then randomized into
      one of two treatment groups. After using, their assigned treatment twice daily at home for 6
      weeks (visit 3), 12 weeks (visit 4) and 24 weeks (visit 5), participants will return to the
      site with overnight plaque at approximately the same time of day as the Baseline visit if
      possible. Participants will undergo a full OST examination and the recording of any Adverse
      Events (AEs). Participants will then undergo MGI, BI followed by dental plaque assessment.
      Microbiological samples will be collected on a subset of 50 participants (Determined by first
      50 participants randomized).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Number of Gingival Bleeding Sites at 24 Weeks
time frame: 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 used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
measure: Modified Gingival Index (MGI) at 24 Weeks
time frame: 24 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: Number of Gingival Bleeding Sites at 6 and 12 Weeks
time frame: Baseline, 6 and 12 weeks
description: BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
measure: Modified Gingival Index (MGI)) at 6 and 12 Weeks.
time frame: 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 (BI) at 6, 12 and 24 Weeks
time frame: 6, 12 and 24 weeks
description: BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system 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) at 6, 12 and 24 Weeks.
time frame: 6, 12 and 24 weeks
description: The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 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 than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.
measure: Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
time frame: Baseline, 6, 12, 24 and 32 weeks
description: Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours).
arm group label: Experimental Dentifrice
arm group type: Experimental
description: Participants were advised to brush their teeth with experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
arm group label: Reference Dentifrice
arm group type: Active Comparator
description: Participants were advised to brush their teeth with reference dentifrice containing 1100ppm fluoride as sodium fluoride
intervention type: Drug
intervention name: Sodium bicarbonate and sodium fluoride
description: Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
arm group label: Experimental Dentifrice
intervention type: Drug
intervention name: Sodium fluoride
description: Comparator toothpaste containing 1100 ppm fluoride as sodium fluoride
arm group label: Reference Dentifrice
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: 