<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/NCT02243046</url>
  </required_header>
  <id_info>
    <org_study_id>CRO-2014-11-PG-ZNPTCN-ED</org_study_id>
    <nct_id>NCT02243046</nct_id>
  </id_info>
  <brief_title>The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis</brief_title>
  <official_title>The Clinical Investigation of a Zinc Based Toothpaste as Compared to a Triclosan Based Toothpaste and Colgate Fluoride Toothpaste in Reducing Established Plaque and Gingivitis - a Six-month Study.</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>
      This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one&#xD;
      hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <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>3 months (from 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>6 months (from 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>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>3 months (from 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>6 months (from 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>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Dental Plaque and Gingivitis</condition>
  <arm_group>
    <arm_group_label>Control toothpaste</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1450 ppm Fluoride toothpaste</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental toothpaste</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1450 ppm sodium fluoride toothpaste with a zinc base</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1450 ppm sodium fluoride/triclosan toothpaste</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control toothpaste</intervention_name>
    <description>1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
    <arm_group_label>Control toothpaste</arm_group_label>
    <other_name>Max Fresh toothpaste</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Experimental toothpaste</intervention_name>
    <description>1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
    <arm_group_label>Experimental toothpaste</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Active Comparator</intervention_name>
    <description>1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
    <arm_group_label>Active comparator</arm_group_label>
    <other_name>Total toothpaste</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Subjects, ages 18-70, inclusive.&#xD;
&#xD;
          2. Availability for the six-month duration of the clinical research 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. Antibiotic use any time during the one-month period 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. Dental prophylaxis during the past two weeks prior to baseline examinations.&#xD;
&#xD;
          9. History of allergies to oral care/personal care consumer products or their&#xD;
             ingredients.&#xD;
&#xD;
         10. On any prescription medicines that might interfere with the study outcome.&#xD;
&#xD;
         11. An existing medical condition that prohibits eating or drinking for periods up to 4&#xD;
             hours.&#xD;
&#xD;
         12. History of alcohol or drug abuse.&#xD;
&#xD;
         13. Pregnant or lactating subjects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Spa Dental</name>
      <address>
        <city>Santo Domingo</city>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Dominican Republic</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>January 28, 2016</results_first_submitted>
  <results_first_submitted_qc>March 30, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 4, 2016</results_first_posted>
  <last_update_submitted>February 21, 2019</last_update_submitted>
  <last_update_submitted_qc>February 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
    <mesh_term>Dental Plaque</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control Toothpaste</title>
          <description>1450 ppm Fluoride toothpaste&#xD;
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
        </group>
        <group group_id="P2">
          <title>Experimental Toothpaste</title>
          <description>1450 ppm sodium fluoride toothpaste with a zinc base&#xD;
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
        </group>
        <group group_id="P3">
          <title>Active Comparator</title>
          <description>1450 ppm sodium fluoride/triclosan toothpaste&#xD;
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="54"/>
                <participants group_id="P3" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>3 Month</title>
              <participants_list>
                <participants group_id="P1" count="54">1 subject didn't return for 3 month clinic visit</participants>
                <participants group_id="P2" count="53">1 subject didn't return for 3 month clinic visit</participants>
                <participants group_id="P3" count="51">2 subjects didn't return for 3 month clinic visit</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>6 Month</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="53"/>
                <participants group_id="P3" count="49">2 subjects didn't return for 6 month clinic visit</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="53"/>
                <participants group_id="P3" count="49"/>
              </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="4"/>
              </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="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control Toothpaste</title>
          <description>1450 ppm Fluoride toothpaste&#xD;
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
        </group>
        <group group_id="B2">
          <title>Experimental Toothpaste</title>
          <description>1450 ppm sodium fluoride toothpaste with a zinc base&#xD;
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
        </group>
        <group group_id="B3">
          <title>Active Comparator</title>
          <description>1450 ppm sodium fluoride/triclosan toothpaste&#xD;
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</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="55"/>
            <count group_id="B2" value="54"/>
            <count group_id="B3" value="53"/>
            <count group_id="B4" value="162"/>
          </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="30.52" spread="10.99"/>
                    <measurement group_id="B2" value="30.92" spread="9.82"/>
                    <measurement group_id="B3" value="30.39" spread="13.47"/>
                    <measurement group_id="B4" value="30.62" spread="11.39"/>
                  </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="34"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="93"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="69"/>
                  </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>Dominican Republic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <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>Control Toothpaste</title>
            <description>1450 ppm Fluoride toothpaste&#xD;
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
          </group>
          <group group_id="O2">
            <title>Experimental Toothpaste</title>
            <description>1450 ppm sodium fluoride toothpaste with a zinc base&#xD;
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
          </group>
          <group group_id="O3">
            <title>Active Comparator</title>
            <description>1450 ppm sodium fluoride/triclosan toothpaste&#xD;
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</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="55"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.48" spread="0.23"/>
                    <measurement group_id="O2" value="1.57" spread="0.28"/>
                    <measurement group_id="O3" value="1.49" spread="0.20"/>
                  </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.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.091</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>3 months (from Baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Toothpaste</title>
            <description>1450 ppm Fluoride toothpaste&#xD;
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
          </group>
          <group group_id="O2">
            <title>Experimental Toothpaste</title>
            <description>1450 ppm sodium fluoride toothpaste with a zinc base&#xD;
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
          </group>
          <group group_id="O3">
            <title>Active Comparator</title>
            <description>1450 ppm sodium fluoride/triclosan toothpaste&#xD;
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</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="54"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.46" spread="0.19"/>
                    <measurement group_id="O2" value="1.33" spread="0.23"/>
                    <measurement group_id="O3" value="1.25" spread="0.18"/>
                  </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.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <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 months (from Baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Toothpaste</title>
            <description>1450 ppm Fluoride toothpaste&#xD;
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
          </group>
          <group group_id="O2">
            <title>Experimental Toothpaste</title>
            <description>1450 ppm sodium fluoride toothpaste with a zinc base&#xD;
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
          </group>
          <group group_id="O3">
            <title>Active Comparator</title>
            <description>1450 ppm sodium fluoride/triclosan toothpaste&#xD;
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</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="54"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.44" spread="0.20"/>
                    <measurement group_id="O2" value="1.23" spread="0.23"/>
                    <measurement group_id="O3" value="1.19" spread="0.17"/>
                  </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</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <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>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Toothpaste</title>
            <description>1450 ppm Fluoride toothpaste&#xD;
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
          </group>
          <group group_id="O2">
            <title>Experimental Toothpaste</title>
            <description>1450 ppm sodium fluoride toothpaste with a zinc base&#xD;
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
          </group>
          <group group_id="O3">
            <title>Active Comparator</title>
            <description>1450 ppm sodium fluoride/triclosan toothpaste&#xD;
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</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="55"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.91" spread="0.24"/>
                    <measurement group_id="O2" value="2.95" spread="0.29"/>
                    <measurement group_id="O3" value="2.90" spread="0.20"/>
                  </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</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.571</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>3 months (from Baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Toothpaste</title>
            <description>1450 ppm Fluoride toothpaste&#xD;
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
          </group>
          <group group_id="O2">
            <title>Experimental Toothpaste</title>
            <description>1450 ppm sodium fluoride toothpaste with a zinc base&#xD;
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
          </group>
          <group group_id="O3">
            <title>Active Comparator</title>
            <description>1450 ppm sodium fluoride/triclosan toothpaste&#xD;
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</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="54"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.59" spread="0.29"/>
                    <measurement group_id="O2" value="2.16" spread="0.53"/>
                    <measurement group_id="O3" value="2.10" 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</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <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 months (from Baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Toothpaste</title>
            <description>1450 ppm Fluoride toothpaste&#xD;
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
          </group>
          <group group_id="O2">
            <title>Experimental Toothpaste</title>
            <description>1450 ppm sodium fluoride toothpaste with a zinc base&#xD;
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
          </group>
          <group group_id="O3">
            <title>Active Comparator</title>
            <description>1450 ppm sodium fluoride/triclosan toothpaste&#xD;
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</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="54"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.47" spread="0.42"/>
                    <measurement group_id="O2" value="1.82" spread="0.45"/>
                    <measurement group_id="O3" value="1.75" spread="0.39"/>
                  </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</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline, 3 and 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control Toothpaste</title>
          <description>1450 ppm Fluoride toothpaste&#xD;
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
        </group>
        <group group_id="E2">
          <title>Experimental Toothpaste</title>
          <description>1450 ppm sodium fluoride toothpaste with a zinc base&#xD;
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</description>
        </group>
        <group group_id="E3">
          <title>Active Comparator</title>
          <description>1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.</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="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </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="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Franklin Garcia-Godoy</name_or_title>
      <organization>Global Research Consultants</organization>
      <phone>954-888-9102</phone>
      <email>fgarciagodoy@gmail.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/NCT02243046
org study id: CRO-2014-11-PG-ZNPTCN-ED
nct id: NCT02243046
lead sponsor: 
has dmc: No
This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one
      hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
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: 3 months (from 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: 6 months (from 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: 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: 3 months (from 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: 6 months (from 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)
arm group label: Control toothpaste
arm group type: Placebo Comparator
description: 1450 ppm Fluoride toothpaste
arm group label: Experimental toothpaste
arm group type: Experimental
description: 1450 ppm sodium fluoride toothpaste with a zinc base
arm group label: Active comparator
arm group type: Active Comparator
description: 1450 ppm sodium fluoride/triclosan toothpaste
intervention type: Drug
intervention name: Control toothpaste
description: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
arm group label: Control toothpaste
other name: Max Fresh toothpaste
intervention type: Drug
intervention name: Experimental toothpaste
description: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
arm group label: Experimental toothpaste
intervention type: Drug
intervention name: Active Comparator
description: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
arm group label: Active comparator
other name: Total toothpaste
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Dominican Republic
responsible party type: Sponsor
mesh term: Gingivitis
mesh term: Dental Plaque
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 