<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/NCT02193165</url>
  </required_header>
  <id_info>
    <org_study_id>CRO-2014-07-PG-REG-PR-BS</org_study_id>
    <nct_id>NCT02193165</nct_id>
  </id_info>
  <brief_title>The Clinical Efficacy of Three Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Dental Plaque and Gingivitis</brief_title>
  <official_title>The Comparative Efficacy of Three Oral Hygiene Multi-component Regimens Encompassing the Use of a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Established Dental Plaque and Gingivitis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colgate Palmolive</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Colgate Palmolive</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this clinical research study is to assess the efficacy of three oral hygiene&#xD;
      multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a&#xD;
      mouthwash in controlling established dental plaque and gingivitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dental Plaque Scores</measure>
    <time_frame>Baseline</time_frame>
    <description>Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dental Plaque Scores</measure>
    <time_frame>4 weeks</time_frame>
    <description>Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dental Plaque Scores</measure>
    <time_frame>6 weeks</time_frame>
    <description>Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gingivitis Scores</measure>
    <time_frame>Baseline</time_frame>
    <description>Gingivitis scale (Loe &amp; Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gingivitis Scores</measure>
    <time_frame>4 weeks</time_frame>
    <description>Gingivitis scale (Loe &amp; Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gingivitis Scores</measure>
    <time_frame>6 weeks</time_frame>
    <description>Gingivitis scale (Loe &amp; Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Dental Plaque</condition>
  <condition>Gingivitis</condition>
  <arm_group>
    <arm_group_label>Regimen 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen 3 - Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>fluoride toothpaste + fluoride Mouthwash</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash</intervention_name>
    <description>Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.</description>
    <arm_group_label>Regimen 1</arm_group_label>
    <other_name>Total toothpaste</other_name>
    <other_name>Total Mouthwash</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash</intervention_name>
    <description>Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.</description>
    <arm_group_label>Regimen 2</arm_group_label>
    <other_name>Crest Pro-Health toothpaste</other_name>
    <other_name>Crest Pro-Health Multi-Protection Mouthwash</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fluoride toothpaste + fluoride Mouthwash</intervention_name>
    <description>Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.</description>
    <arm_group_label>Regimen 3 - Control group</arm_group_label>
    <other_name>Crest Cavity Protection toothpaste</other_name>
    <other_name>Crest Pro-Health For Me Breezy Mint mouthwash</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects, ages 21-70, inclusive.&#xD;
&#xD;
          2. Availability for the six-week duration of the study.&#xD;
&#xD;
          3. Good general health.&#xD;
&#xD;
          4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).&#xD;
&#xD;
          5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and&#xD;
             Silness Gingival Index.&#xD;
&#xD;
          6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein&#xD;
             Plaque Index (Turesky Modification).&#xD;
&#xD;
          7. Signed Informed Consent Form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of orthodontic bands.&#xD;
&#xD;
          2. Presence of partial removable dentures.&#xD;
&#xD;
          3. Tumor(s) of the soft or hard tissues of the oral cavity.&#xD;
&#xD;
          4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss&#xD;
             of periodontal attachment or alveolar bone).&#xD;
&#xD;
          5. Five or more carious lesions requiring immediate restorative treatment.&#xD;
&#xD;
          6. Use of antibiotics any time during the one month prior to entry into the study.&#xD;
&#xD;
          7. Participation in any other clinical study or test panel within the one month prior to&#xD;
             entry into the study.&#xD;
&#xD;
          8. Pregnant women or women who are breast feeding.&#xD;
&#xD;
          9. Dental prophylaxis received in the past two weeks prior to baseline examinations.&#xD;
&#xD;
         10. History of allergies to oral care/personal care consumer products or their&#xD;
             ingredients.&#xD;
&#xD;
         11. On any prescription medicines that might interfere with the study outcome.&#xD;
&#xD;
         12. An existing medical condition which prohibits eating or drinking for periods up to 4&#xD;
             hours.&#xD;
&#xD;
         13. History of alcohol or drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centro Comercial Plaza Trujillo</name>
      <address>
        <city>Trujillo Alto</city>
        <zip>00976</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <results_first_submitted>November 14, 2014</results_first_submitted>
  <results_first_submitted_qc>February 4, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 6, 2015</results_first_posted>
  <last_update_submitted>July 27, 2015</last_update_submitted>
  <last_update_submitted_qc>July 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
    <mesh_term>Dental Plaque</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triclosan</mesh_term>
    <mesh_term>Cetylpyridinium</mesh_term>
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Tin Fluorides</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>recruitment at clinical site</recruitment_details>
      <pre_assignment_details>There is no wash-out period prior to product randomization and distribution. Each subject was randomized and given a study treatment to follow after successfully completing the study screening procedures.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Regimen 1</title>
          <description>triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.</description>
        </group>
        <group group_id="P2">
          <title>Regimen 2</title>
          <description>stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.</description>
        </group>
        <group group_id="P3">
          <title>Regimen 3 - Control Group</title>
          <description>fluoride toothpaste + fluoride Mouthwash&#xD;
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>4 Week Product Use</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39">1 subject failed to keep appointments and didn't return to clinical site</participants>
                <participants group_id="P2" count="39">1 subject failed to keep appointments and didn't return to clinical site</participants>
                <participants group_id="P3" count="39">1 subject failed to keep appointments and didn't return to clinical site</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </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="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6 Week Product Use</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="38">1 subject failed to keep appointment time and didn't return to clinical site.</participants>
                <participants group_id="P3" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </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="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Regimen 1</title>
          <description>triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.</description>
        </group>
        <group group_id="B2">
          <title>Regimen 2</title>
          <description>stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.</description>
        </group>
        <group group_id="B3">
          <title>Regimen 3 - Control Group</title>
          <description>fluoride toothpaste + fluoride Mouthwash&#xD;
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.</description>
        </group>
        <group group_id="B4">
          <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="40"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="40"/>
            <count group_id="B4" value="120"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </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="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Dental Plaque Scores</title>
        <description>Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Regimen 1</title>
            <description>triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>Regimen 2</title>
            <description>stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>Regimen 3 - Control Group</title>
            <description>fluoride toothpaste + fluoride Mouthwash&#xD;
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.</description>
          </group>
        </group_list>
        <measure>
          <title>Dental Plaque Scores</title>
          <description>Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)</description>
          <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="40"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.33" spread="0.52"/>
                    <measurement group_id="O2" value="3.19" spread="0.53"/>
                    <measurement group_id="O3" value="3.31" spread="0.48"/>
                  </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>O3</group_id>
            </group_id_list>
            <groups_desc>Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different. Significance will be determined by p&lt;0.5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.434</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dental Plaque Scores</title>
        <description>Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Regimen 1</title>
            <description>triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>Regimen 2</title>
            <description>stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>Regimen 3 - Control Group</title>
            <description>fluoride toothpaste + fluoride Mouthwash&#xD;
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.</description>
          </group>
        </group_list>
        <measure>
          <title>Dental Plaque Scores</title>
          <description>Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)</description>
          <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="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.78" spread="0.56"/>
                    <measurement group_id="O2" value="2.79" spread="0.52"/>
                    <measurement group_id="O3" value="3.34" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups determined by P&lt;0.05</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dental Plaque Scores</title>
        <description>Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Regimen 1</title>
            <description>triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>Regimen 2</title>
            <description>stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>Regimen 3 - Control Group</title>
            <description>fluoride toothpaste + fluoride Mouthwash&#xD;
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.</description>
          </group>
        </group_list>
        <measure>
          <title>Dental Plaque Scores</title>
          <description>Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)</description>
          <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="39"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.42" spread="0.62"/>
                    <measurement group_id="O2" value="2.59" spread="0.58"/>
                    <measurement group_id="O3" value="3.38" spread="0.49"/>
                  </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>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups will be determined at P&lt;0.05</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Gingivitis Scores</title>
        <description>Gingivitis scale (Loe &amp; Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Regimen 1</title>
            <description>triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>Regimen 2</title>
            <description>stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>Regimen 3 - Control Group</title>
            <description>fluoride toothpaste + fluoride Mouthwash&#xD;
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.</description>
          </group>
        </group_list>
        <measure>
          <title>Gingivitis Scores</title>
          <description>Gingivitis scale (Loe &amp; Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)</description>
          <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="40"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.40" spread="0.31"/>
                    <measurement group_id="O2" value="1.40" spread="0.32"/>
                    <measurement group_id="O3" value="1.44" spread="0.37"/>
                  </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>O3</group_id>
            </group_id_list>
            <groups_desc>Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups. Differences will be noted at P&lt;0.05. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.816</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Gingivitis Scores</title>
        <description>Gingivitis scale (Loe &amp; Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Regimen 1</title>
            <description>triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>Regimen 2</title>
            <description>stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>Regimen 3 - Control Group</title>
            <description>fluoride toothpaste + fluoride Mouthwash&#xD;
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.</description>
          </group>
        </group_list>
        <measure>
          <title>Gingivitis Scores</title>
          <description>Gingivitis scale (Loe &amp; Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)</description>
          <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="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.19" spread="0.23"/>
                    <measurement group_id="O2" value="1.30" spread="0.27"/>
                    <measurement group_id="O3" value="1.44" spread="0.37"/>
                  </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>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P&lt;0.05</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Gingivitis Scores</title>
        <description>Gingivitis scale (Loe &amp; Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Regimen 1</title>
            <description>triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>Regimen 2</title>
            <description>stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>Regimen 3 - Control Group</title>
            <description>fluoride toothpaste + fluoride Mouthwash&#xD;
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.</description>
          </group>
        </group_list>
        <measure>
          <title>Gingivitis Scores</title>
          <description>Gingivitis scale (Loe &amp; Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)</description>
          <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="39"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" spread="0.14"/>
                    <measurement group_id="O2" value="1.21" spread="0.24"/>
                    <measurement group_id="O3" value="1.46" spread="0.36"/>
                  </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>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P&lt;0.05</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <desc>Duration of study</desc>
      <group_list>
        <group group_id="E1">
          <title>Regimen 1</title>
          <description>triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.</description>
        </group>
        <group group_id="E2">
          <title>Regimen 2</title>
          <description>stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash&#xD;
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.</description>
        </group>
        <group group_id="E3">
          <title>Regimen 3 - Control Group</title>
          <description>fluoride toothpaste + fluoride Mouthwash&#xD;
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.</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="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>William Devizio</name_or_title>
      <organization>Colgate Palmolive</organization>
      <phone>732-878-7901</phone>
      <email>william_devizio@colpal.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02193165
org study id: CRO-2014-07-PG-REG-PR-BS
nct id: NCT02193165
lead sponsor: 
has dmc: No
The objective of this clinical research study is to assess the efficacy of three oral hygiene
      multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a
      mouthwash in controlling established dental plaque and gingivitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Dental Plaque Scores
time frame: Baseline
description: Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
measure: Dental Plaque Scores
time frame: 4 weeks
description: Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
measure: Dental Plaque Scores
time frame: 6 weeks
description: Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
measure: Gingivitis Scores
time frame: Baseline
description: Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
measure: Gingivitis Scores
time frame: 4 weeks
description: Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
measure: Gingivitis Scores
time frame: 6 weeks
description: Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
arm group label: Regimen 1
arm group type: Active Comparator
description: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
arm group label: Regimen 2
arm group type: Active Comparator
description: stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
arm group label: Regimen 3 - Control group
arm group type: Placebo Comparator
description: fluoride toothpaste + fluoride Mouthwash
intervention type: Drug
intervention name: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
description: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
arm group label: Regimen 1
other name: Total toothpaste
other name: Total Mouthwash
intervention type: Drug
intervention name: stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
description: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.
arm group label: Regimen 2
other name: Crest Pro-Health toothpaste
other name: Crest Pro-Health Multi-Protection Mouthwash
intervention type: Drug
intervention name: fluoride toothpaste + fluoride Mouthwash
description: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
arm group label: Regimen 3 - Control group
other name: Crest Cavity Protection toothpaste
other name: Crest Pro-Health For Me Breezy Mint mouthwash
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Puerto Rico
responsible party type: Sponsor
mesh term: Gingivitis
mesh term: Dental Plaque
mesh term: Triclosan
mesh term: Cetylpyridinium
mesh term: Fluorides
mesh term: Tin Fluorides
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 