<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/NCT02194621</url>
  </required_header>
  <id_info>
    <org_study_id>CRO-1113-BACT-PS-NJ</org_study_id>
    <nct_id>NCT02194621</nct_id>
  </id_info>
  <brief_title>Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria</brief_title>
  <official_title>A Randomized, Single Center, Three Cell, Double Blind and Parallel Groups Clinical Study Conducted in Newark, NJ to Evaluate the Antibacterial Effects of Two Toothpastes Containing 0.3% Triclosan/2% Copolymer/0.243% Sodium Fluoride in a Silica Base as Compared to a Control Regular Fluoride Toothpaste on Oral Bacteria 12 Hours After 13 Days Product Use.</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 primary objective was to evaluate the antibacterial effects of two toothpastes containing&#xD;
      0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a&#xD;
      control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days&#xD;
      of product use. A secondary objective was to demonstrate that a toothpaste containing 0.3%&#xD;
      triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with odor-masking ingredients in&#xD;
      silica base (Colgate Total Toothpaste-Flavor Option 1) provides a level of antibacterial&#xD;
      efficacy that is &quot;equivalent&quot; to a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234%&#xD;
      sodium fluoride and a regular flavor in silica base (Colgate Total Toothpaste-Flavor Option&#xD;
      2) after 13 days of product use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anaerobic Bacteria</measure>
    <time_frame>Baseline</time_frame>
    <description>Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anaerobic Bacteria</measure>
    <time_frame>12 hours</time_frame>
    <description>Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Malodor Bacteria (Breath Odor Causing Bacteria)</measure>
    <time_frame>Baseline</time_frame>
    <description>Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Malodor Bacteria (Breath Odor Causing Bacteria)</measure>
    <time_frame>12 hours</time_frame>
    <description>Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Oral Bacteria Levels in the Mouth</condition>
  <arm_group>
    <arm_group_label>Total Flavor Option 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 1 ingredient - Total Flavor Option 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Total Flavor Option 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 2 ingredient. Total Flavor Option 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Crest Toothpaste</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Total Flavor option 1</intervention_name>
    <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1</description>
    <arm_group_label>Total Flavor Option 1</arm_group_label>
    <other_name>Total toothpaste</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Total Flavor option 2</intervention_name>
    <description>Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2</description>
    <arm_group_label>Total Flavor Option 2</arm_group_label>
    <other_name>Total toothpaste</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo toothpaste: Crest Cavity Protection toothpaste</intervention_name>
    <description>Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)</description>
    <arm_group_label>Crest Toothpaste</arm_group_label>
    <other_name>Crest Anti-Cavity toothpaste</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females in good general health aged 18 to 70 years.&#xD;
&#xD;
          2. A willingness to read, understand, and sign the Informed Consent Form after the nature&#xD;
             of the study has been fully explained to them. Subject should demonstrate a&#xD;
             willingness to comply with all study procedures and sampling schedules.&#xD;
&#xD;
          3. A minimum of 20 natural teeth with facial and lingual scorable surfaces.&#xD;
&#xD;
          4. Adequate oral hygiene and no signs of oral neglect.&#xD;
&#xD;
          5. Good periodontal health. Enrolled subjects will have no more than five periodontal&#xD;
             pockets of 5 mm.&#xD;
&#xD;
          6. Subjects with gingival index greater than or equal to 1.0 (Loe-Silness Index) and&#xD;
             plaque index greater than or equal to 1.5 (Turesky modification of Quigley-Hein Index)&#xD;
             will be enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of significant adverse effects following use of oral hygiene products such as&#xD;
             toothpastes and mouthrinses. Allergy to personal care/consumer products or their&#xD;
             ingredients.&#xD;
&#xD;
          2. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or&#xD;
             lingual surfaces, orthodontically banded, abutments, or third molars&#xD;
&#xD;
          3. History of diabetes or hepatic or renal disease, or other serious medical conditions&#xD;
             or transmittable diseases, e.g. heart disease or AIDS.&#xD;
&#xD;
          4. History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions&#xD;
             requiring prophylactic antibiotic coverage prior to invasive dental procedures.&#xD;
&#xD;
          5. Subjects on antibiotic, anti-inflammatory or anticoagulant therapy during the month&#xD;
             preceding the baseline exam.&#xD;
&#xD;
          6. Significant oral soft tissue pathology, systemically related gingival enlargement,&#xD;
             severe gingivitis (based on a visual examinations).&#xD;
&#xD;
          7. History of active severe periodontal disease with bleeding gums and loose teeth.&#xD;
&#xD;
          8. Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion,&#xD;
             large fractured or temporary restorations (based on visual examinations).will not be&#xD;
             included in the tooth count.&#xD;
&#xD;
          9. Fixed or removable orthodontic appliance or removable partial dentures.&#xD;
&#xD;
         10. Participation in a dental plaque/gingivitis clinical study involving oral care&#xD;
             products, within the last 30 days. History of dental prophylaxis or treatments in the&#xD;
             past month.&#xD;
&#xD;
         11. Self reported pregnancy or lactation.&#xD;
&#xD;
         12. History or current use of objects to pierce the lips or tongue.&#xD;
&#xD;
         13. Subjects known to be an alcoholic, or a recovering alcoholic.&#xD;
&#xD;
         14. History or current use of recreational drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>58 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rutgers School of Dental Medicine</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</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 18, 2014</study_first_posted>
  <results_first_submitted>February 1, 2016</results_first_submitted>
  <results_first_submitted_qc>March 30, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 15, 2016</results_first_posted>
  <last_update_submitted>March 30, 2016</last_update_submitted>
  <last_update_submitted_qc>March 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <recruitment_details>subject recruitment is completed locally at the clinical site</recruitment_details>
      <pre_assignment_details>There will be a one (1) week wash out phase with commercially available fluoride toothpaste prior to any study intervention being assigned.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Total Flavor Option 1</title>
          <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1&#xD;
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1</description>
        </group>
        <group group_id="P2">
          <title>Total Flavor Option 2</title>
          <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2&#xD;
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2</description>
        </group>
        <group group_id="P3">
          <title>Crest Toothpaste</title>
          <description>Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)&#xD;
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>6 withdrew prior to randomization</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Total Flavor Option 1</title>
          <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1&#xD;
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1</description>
        </group>
        <group group_id="B2">
          <title>Total Flavor Option 2</title>
          <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2&#xD;
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2</description>
        </group>
        <group group_id="B3">
          <title>Crest Toothpaste</title>
          <description>Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)&#xD;
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)</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="43"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="43"/>
            <count group_id="B4" value="128"/>
          </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="36.6" spread="10.2"/>
                    <measurement group_id="B2" value="34.2" spread="10.34"/>
                    <measurement group_id="B3" value="35.9" spread="12.08"/>
                    <measurement group_id="B4" value="35.4" spread="10.82"/>
                  </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="28"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="47"/>
                  </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="43"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Anaerobic Bacteria</title>
        <description>Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Total Flavor Option 1</title>
            <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1&#xD;
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1</description>
          </group>
          <group group_id="O2">
            <title>Total Flavor Option 2</title>
            <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2&#xD;
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2</description>
          </group>
          <group group_id="O3">
            <title>Crest Toothpaste</title>
            <description>Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)&#xD;
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)</description>
          </group>
        </group_list>
        <measure>
          <title>Anaerobic Bacteria</title>
          <description>Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.</description>
          <units>colony forming units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.40" spread="0.33"/>
                    <measurement group_id="O2" value="8.42" spread="0.25"/>
                    <measurement group_id="O3" value="8.43" spread="0.28"/>
                  </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>&gt;0.05</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anaerobic Bacteria</title>
        <description>Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.</description>
        <time_frame>12 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Total Flavor Option 1</title>
            <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1&#xD;
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1</description>
          </group>
          <group group_id="O2">
            <title>Total Flavor Option 2</title>
            <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2&#xD;
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2</description>
          </group>
          <group group_id="O3">
            <title>Crest Toothpaste</title>
            <description>Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)&#xD;
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)</description>
          </group>
        </group_list>
        <measure>
          <title>Anaerobic Bacteria</title>
          <description>Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.</description>
          <units>colony forming units</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.68" spread="0.09"/>
                    <measurement group_id="O2" value="7.71" spread="0.09"/>
                    <measurement group_id="O3" value="8.37" spread="0.09"/>
                  </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.</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>Malodor Bacteria (Breath Odor Causing Bacteria)</title>
        <description>Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Total Flavor Option 1</title>
            <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1&#xD;
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1</description>
          </group>
          <group group_id="O2">
            <title>Total Flavor Option 2</title>
            <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2&#xD;
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2</description>
          </group>
          <group group_id="O3">
            <title>Crest Toothpaste</title>
            <description>Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)&#xD;
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)</description>
          </group>
        </group_list>
        <measure>
          <title>Malodor Bacteria (Breath Odor Causing Bacteria)</title>
          <description>Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.</description>
          <units>colony forming units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.26" spread="0.44"/>
                    <measurement group_id="O2" value="6.26" spread="0.50"/>
                    <measurement group_id="O3" value="6.40" spread="0.46"/>
                  </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>&gt;0.05</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Malodor Bacteria (Breath Odor Causing Bacteria)</title>
        <description>Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.</description>
        <time_frame>12 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Total Flavor Option 1</title>
            <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1&#xD;
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1</description>
          </group>
          <group group_id="O2">
            <title>Total Flavor Option 2</title>
            <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2&#xD;
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2</description>
          </group>
          <group group_id="O3">
            <title>Crest Toothpaste</title>
            <description>Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)&#xD;
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)</description>
          </group>
        </group_list>
        <measure>
          <title>Malodor Bacteria (Breath Odor Causing Bacteria)</title>
          <description>Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.</description>
          <units>colony forming units</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.99" spread="0.07"/>
                    <measurement group_id="O2" value="5.92" spread="0.07"/>
                    <measurement group_id="O3" value="6.32" spread="0.07"/>
                  </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>0.002</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline, 12 hours and 2 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Total Flavor Option 1</title>
          <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1&#xD;
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1</description>
        </group>
        <group group_id="E2">
          <title>Total Flavor Option 2</title>
          <description>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2&#xD;
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2</description>
        </group>
        <group group_id="E3">
          <title>Crest Toothpaste</title>
          <description>Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)&#xD;
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)</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="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="43"/>
              </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="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="43"/>
              </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>Daniel Fine, DMD</name_or_title>
      <organization>RBHS-Rutgers School of Dental Medicine, Oral Biology Department</organization>
      <phone>973-972-3728</phone>
      <email>finedh@sdm.rutgers.edu</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/NCT02194621
org study id: CRO-1113-BACT-PS-NJ
nct id: NCT02194621
lead sponsor: 
has dmc: No
The primary objective was to evaluate the antibacterial effects of two toothpastes containing
      0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a
      control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days
      of product use. A secondary objective was to demonstrate that a toothpaste containing 0.3%
      triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with odor-masking ingredients in
      silica base (Colgate Total Toothpaste-Flavor Option 1) provides a level of antibacterial
      efficacy that is "equivalent" to a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234%
      sodium fluoride and a regular flavor in silica base (Colgate Total Toothpaste-Flavor Option
      2) after 13 days of product use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Anaerobic Bacteria
time frame: Baseline
description: Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
measure: Anaerobic Bacteria
time frame: 12 hours
description: Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
measure: Malodor Bacteria (Breath Odor Causing Bacteria)
time frame: Baseline
description: Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.
measure: Malodor Bacteria (Breath Odor Causing Bacteria)
time frame: 12 hours
description: Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.
arm group label: Total Flavor Option 1
arm group type: Experimental
description: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 1 ingredient - Total Flavor Option 1
arm group label: Total Flavor Option 2
arm group type: Experimental
description: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 2 ingredient. Total Flavor Option 2
arm group label: Crest Toothpaste
arm group type: Placebo Comparator
description: Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)
intervention type: Drug
intervention name: Total Flavor option 1
description: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1
arm group label: Total Flavor Option 1
other name: Total toothpaste
intervention type: Drug
intervention name: Total Flavor option 2
description: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2
arm group label: Total Flavor Option 2
other name: Total toothpaste
intervention type: Drug
intervention name: Placebo toothpaste: Crest Cavity Protection toothpaste
description: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
arm group label: Crest Toothpaste
other name: Crest Anti-Cavity toothpaste
criteria: 
gender: All
minimum age: 22 Years
maximum age: 58 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 