<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/NCT02233998</url>
  </required_header>
  <id_info>
    <org_study_id>CO-140508133810-OCCT</org_study_id>
    <nct_id>NCT02233998</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Test the Effect of Marketed Mouth Rinses on Decreasing Plaque and Gum Inflammation</brief_title>
  <official_title>21 Day Clinical Efficacy of Essential Oil Containing Mouth Rinses: Effect on Reducing Existing Gingivitis and Plaque</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Consumer and Personal Products Worldwide</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Consumer and Personal Products Worldwide</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The reduction of existing plaque and gum inflammation will be evaluated using two marketed&#xD;
      mouth rinses along with tooth brushing after 21 days of use compared to a placebo mouth&#xD;
      rinse.&#xD;
&#xD;
      165 healthy volunteers will be enrolled in this three week study. Volunteers who qualify to&#xD;
      be in this study will have an equal chance of being assigned to one of the three treatment&#xD;
      groups. Volunteers will have a total of three visits including 1) Screening/Baseline Day 1 2)&#xD;
      Day 11 (after 10 days of use) and 3) Day 22 (after 21 days of use). Volunteers will maintain&#xD;
      a diary at home to record each treatment use and will be asked to come to the clinic without&#xD;
      brushing or use their product for at least 8 hours, but no more than 18 hours. Examinations&#xD;
      for oral hard/soft tissue, gingivitis, bleeding and plaque assessments will be completed at&#xD;
      Screening/Baseline and repeated at Clinic Visit 3, which is Day 22.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A sufficient number of generally healthy subjects (approximately 165) that meet the required&#xD;
      inclusion/exclusion criteria will be enrolled in this 21 day, examiner-blind, single center,&#xD;
      randomized, parallel-group controlled clinical trial to ensure that at least 150 subjects (50&#xD;
      per treatment group) complete this study.&#xD;
&#xD;
      At baseline, the prescreened subjects will present to the clinic site for baseline&#xD;
      examinations (oral tissue assessment, gingivitis, bleeding and plaque assessments) having&#xD;
      refrained from oral hygiene for at least 8 hours, but no more than 18 hours. After the&#xD;
      baseline oral examinations, assessment of other inclusion/exclusion criteria qualifying&#xD;
      subjects will be randomly assigned to one of three treatment groups. Immediately following&#xD;
      this randomization, subjects will begin use of their assigned test product following the&#xD;
      label instructions. If randomized to the control group, subjects will brush twice daily in&#xD;
      their usual manner with an ADA accepted fluoride toothpaste and a soft bristled toothbrush&#xD;
      followed by rinsing twice daily with a 5% hydroalcohol control rinse (W002194-221P). If&#xD;
      randomized to an active treatment group; subjects will brush twice daily in their usual&#xD;
      manner, followed by rinsing twice daily with their assigned mouth rinse formulation&#xD;
      (19292-116A or 11965-059). Subjects will be instructed to follow label instructions 20ml for&#xD;
      30 seconds twice daily for mouth rinse product. The first product use will be conducted under&#xD;
      the supervision of study personnel. All other brushing and rinsing will be unsupervised and&#xD;
      the subjects will be required to maintain a diary card to document twice daily product use,&#xD;
      brushing and rinsing times. Compliance will be evaluated by weighing residual volumes of&#xD;
      returned mouth rinse and by reviewing the subject diary. Subjects will receive an ADA-&#xD;
      accepted fluoride-containing dentifrice and a soft bristled toothbrush at their baseline&#xD;
      visit.&#xD;
&#xD;
      Subjects may continue to use floss to remove impacted food between the teeth if it is part of&#xD;
      their usual oral care regimen during the course of the study; no other oral hygiene&#xD;
      procedures will be permitted, including teeth cleaning, whitening or dental procedures except&#xD;
      for an emergency treatment. The decision to withdraw a subject due to emergency dental&#xD;
      treatment will occur at the discretion of the Investigator.&#xD;
&#xD;
      At baseline and three weeks (±2 days) visits, subject will not have brushed or have used&#xD;
      their product for at least 8 hours, but no more than 18 hours.&#xD;
&#xD;
      Oral tissue safety, Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI)&#xD;
      will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</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>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Whole Mouth Mean Modified Gingival Index (MGI) at Week 3</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Whole Mouth Mean Plaque Index (PI) at Week 3</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was calculated by averaging their tooth site scores at Week 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3</measure>
    <time_frame>Baseline to 3 Weeks</time_frame>
    <description>Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline in the percentage of sites with an MGI score of 0 or 1 at Week 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3</measure>
    <time_frame>Baseline to 3 Weeks</time_frame>
    <description>Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline in the percentage of sites with a PI score of 0 or 1 at Week 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3</measure>
    <time_frame>Baseline to 3 Weeks</time_frame>
    <description>Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was the change from baseline in the percentage of sites with a BI score of 0 at Week 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3</measure>
    <time_frame>Baseline to 3 Weeks</time_frame>
    <description>Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with an MGI score ≥3 at Week 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3</measure>
    <time_frame>Baseline to 3 Weeks</time_frame>
    <description>Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥3 at Week 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3</measure>
    <time_frame>Baseline to 3 Weeks</time_frame>
    <description>Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥2 at Week 3.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">158</enrollment>
  <condition>Plaque</condition>
  <condition>Gingivitis</condition>
  <arm_group>
    <arm_group_label>Mouth Rinse 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mouth Rinse 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mouth Rinse 3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mouth Rinse 1</intervention_name>
    <arm_group_label>Mouth Rinse 1</arm_group_label>
    <other_name>Cool Mint Listerine Antiseptic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mouth Rinse 2</intervention_name>
    <arm_group_label>Mouth Rinse 2</arm_group_label>
    <other_name>Listerine Zero</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mouth Rinse 3</intervention_name>
    <arm_group_label>Mouth Rinse 3</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Able to comprehend and follow the requirements of the study (including availability on&#xD;
             scheduled visit dates) based upon research site personnel's assessment;&#xD;
&#xD;
          2. Evidence of a personally signed and dated informed consent document indicating the&#xD;
             subject (or legally acceptable representative) has been informed of all pertinent&#xD;
             aspects of the trial;&#xD;
&#xD;
          3. Males and females 18 years of age or older, in good general and oral health without&#xD;
             any known allergy to commercial dental products;&#xD;
&#xD;
          4. A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that&#xD;
             are grossly carious, extensively restored, orthodontically banded, abutments,&#xD;
             exhibiting severe generalized cervical and/or enamel abrasion, or third molars will&#xD;
             not be included in the tooth count;&#xD;
&#xD;
          5. A mean gingival index ≥ 1.95 according to the Modified Gingival Index;&#xD;
&#xD;
          6. A mean plaque index ≥ 1.95 according to the Turesky modification of the Quigley-Hein&#xD;
             Plaque Index scored on six surfaces per tooth;&#xD;
&#xD;
          7. Absence of significant oral soft tissue pathology, excluding plaque-induced&#xD;
             gingivitis, based on a visual examination and at the discretion of the Investigator;&#xD;
&#xD;
          8. Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type&#xD;
             III, IV).&#xD;
&#xD;
          9. Absence of fixed or removable orthodontic appliance or removable partial dentures;&#xD;
&#xD;
         10. Able to read and understand the local language;&#xD;
&#xD;
         11. Male or non-pregnant, non-lactating female, by self-report;&#xD;
&#xD;
         12. Male and female subjects with reproductive potential must agree to practice a&#xD;
             medically acceptable form of birth control during the study and for 30 days following&#xD;
             the last dose of investigational product. Females must have used such birth control&#xD;
             for at least 3 months prior to the Baseline visit.&#xD;
&#xD;
             Medically acceptable forms of birth control that may be used by the subject and/or&#xD;
             his/her partner include:&#xD;
&#xD;
               -  Abstinence from reproductive intercourse when this is in line with the preferred&#xD;
                  and usual lifestyle of the subject. Periodic abstinence (e.g., calendar,&#xD;
                  ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not&#xD;
                  acceptable methods of contraception;&#xD;
&#xD;
               -  Established use of hormonal methods of contraception (oral, injected, implanted,&#xD;
                  patch or vaginal ring);&#xD;
&#xD;
               -  Intrauterine device (IUD) or intrauterine system (IUS);&#xD;
&#xD;
               -  Barrier methods of contraception with spermicide: condom or occlusive cap&#xD;
                  (diaphragm or cervical/vault caps) with spermicidal&#xD;
                  foam/gel/film/cream/suppository;&#xD;
&#xD;
               -  Surgical sterilization (e.g., vasectomy that has been confirmed effective by&#xD;
                  sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy); and&#xD;
&#xD;
               -  A female subject who is postmenopausal (i.e., amenorrheic for at least 12 months&#xD;
                  prior to the Baseline visit) is not considered of reproductive potential.&#xD;
&#xD;
         13. Willing for this to be the only investigational product used during this time period;&#xD;
             and&#xD;
&#xD;
         14. Willing and able to comply with all study procedures and attend the scheduled visits&#xD;
             for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects presenting with any of the following will not be included in the study:&#xD;
&#xD;
          1. History of significant adverse effects, including sensitivities or suspected&#xD;
             allergies, following use of oral hygiene products such as toothpastes and mouth rinses&#xD;
             and red food dye;&#xD;
&#xD;
          2. Dental prophylaxis within 2 weeks prior to Screening visit;&#xD;
&#xD;
          3. Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within one&#xD;
             month prior to the baseline exam;&#xD;
&#xD;
          4. Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan,&#xD;
             essential oil, cetylpyridinium chloride, or chlorhexidine containing mouth rinses&#xD;
             within three weeks prior to baseline;&#xD;
&#xD;
          5. Self-reported pregnancy or lactation (this criterion is due to oral tissue changes&#xD;
             related to pregnancy and nursing which can affect interpretation of study results);&#xD;
&#xD;
          6. Significant unstable or uncontrolled medical condition which may interfere with a&#xD;
             subject's participation in the study, at the discretion of the Investigator;&#xD;
&#xD;
          7. Participation in any other clinical study within 30 days of Visit 1;&#xD;
&#xD;
          8. Subjects who are related to those persons involved directly or indirectly with the&#xD;
             conduct of this study (i.e., principal investigator, sub-investigators, study&#xD;
             coordinators, other site personnel, employees of Johnson &amp; Johnson subsidiaries,&#xD;
             contractors of Johnson &amp; Johnson, and the families of each); and&#xD;
&#xD;
          9. Other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
             abnormality that may increase the risk associated with study participation, substance&#xD;
             or alcohol abuse or may interfere with the interpretation of study results and, in the&#xD;
             judgment of the investigator, would make the subject inappropriate for entry into the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maher Naji, D.D.S</last_name>
    <role>Principal Investigator</role>
    <affiliation>All Sum Research Center Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>All Sum Research Center Ltd.</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L4W0C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>June 29, 2015</results_first_submitted>
  <results_first_submitted_qc>June 29, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 28, 2015</results_first_posted>
  <last_update_submitted>July 31, 2015</last_update_submitted>
  <last_update_submitted_qc>July 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Plaque</keyword>
  <keyword>Bleeding</keyword>
  <keyword>Gums</keyword>
  <keyword>Gingiva</keyword>
  <keyword>Gingival Inflammation</keyword>
  <keyword>Gingival Bleeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Negative Control (W002194-221P)</title>
          <description>Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing</description>
        </group>
        <group group_id="P2">
          <title>19292-116A</title>
          <description>Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing</description>
        </group>
        <group group_id="P3">
          <title>11965-059</title>
          <description>Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Negative Control (W002194-221P)</title>
          <description>Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing</description>
        </group>
        <group group_id="B2">
          <title>19292-116A</title>
          <description>Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing</description>
        </group>
        <group group_id="B3">
          <title>11965-059</title>
          <description>Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing</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="53"/>
            <count group_id="B2" value="52"/>
            <count group_id="B3" value="53"/>
            <count group_id="B4" value="158"/>
          </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="46.2" spread="10.97"/>
                    <measurement group_id="B2" value="41.7" spread="12.48"/>
                    <measurement group_id="B3" value="45.5" spread="11.18"/>
                    <measurement group_id="B4" value="44.5" spread="11.66"/>
                  </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="39"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="58"/>
                  </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>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Whole Mouth Mean Modified Gingival Index (MGI) at Week 3</title>
        <description>Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.</description>
        <time_frame>3 Weeks</time_frame>
        <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Negative Control (W002194-221P)</title>
            <description>Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O2">
            <title>19292-116A</title>
            <description>Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O3">
            <title>11965-059</title>
            <description>Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
        </group_list>
        <measure>
          <title>Whole Mouth Mean Modified Gingival Index (MGI) at Week 3</title>
          <description>Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.</description>
          <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.004" spread="0.0114"/>
                    <measurement group_id="O2" value="1.770" spread="0.0115"/>
                    <measurement group_id="O3" value="1.807" spread="0.0113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.</method_desc>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.234</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0162</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.266</ci_lower_limit>
            <ci_upper_limit>-0.202</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.</method_desc>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.197</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0161</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.228</ci_lower_limit>
            <ci_upper_limit>-0.165</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Whole Mouth Mean Plaque Index (PI) at Week 3</title>
        <description>Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3.</description>
        <time_frame>3 Weeks</time_frame>
        <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Negative Control (W002194-221P)</title>
            <description>Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O2">
            <title>19292-116A</title>
            <description>Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O3">
            <title>11965-059</title>
            <description>Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
        </group_list>
        <measure>
          <title>Whole Mouth Mean Plaque Index (PI) at Week 3</title>
          <description>Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3.</description>
          <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.434" spread="0.0202"/>
                    <measurement group_id="O2" value="1.965" spread="0.0204"/>
                    <measurement group_id="O3" value="2.055" spread="0.0202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment with baseline whole mouth mean plaque index as a covariate.</method_desc>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.469</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0286</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.526</ci_lower_limit>
            <ci_upper_limit>-0.413</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment with baseline whole mouth mean plaque index as a covariate.</method_desc>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.379</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0286</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.435</ci_lower_limit>
            <ci_upper_limit>-0.322</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3</title>
        <description>Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was calculated by averaging their tooth site scores at Week 3.</description>
        <time_frame>3 Weeks</time_frame>
        <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Negative Control (W002194-221P)</title>
            <description>Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O2">
            <title>19292-116A</title>
            <description>Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O3">
            <title>11965-059</title>
            <description>Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
        </group_list>
        <measure>
          <title>Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3</title>
          <description>Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was calculated by averaging their tooth site scores at Week 3.</description>
          <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.098" spread="0.0042"/>
                    <measurement group_id="O2" value="0.067" spread="0.0042"/>
                    <measurement group_id="O3" value="0.072" spread="0.0042"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.</method_desc>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.030</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0060</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.042</ci_lower_limit>
            <ci_upper_limit>-0.019</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.</method_desc>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.026</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0059</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.038</ci_lower_limit>
            <ci_upper_limit>-0.014</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3</title>
        <description>Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline in the percentage of sites with an MGI score of 0 or 1 at Week 3.</description>
        <time_frame>Baseline to 3 Weeks</time_frame>
        <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Negative Control (W002194-221P)</title>
            <description>Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O2">
            <title>19292-116A</title>
            <description>Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O3">
            <title>11965-059</title>
            <description>Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3</title>
          <description>Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline in the percentage of sites with an MGI score of 0 or 1 at Week 3.</description>
          <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>percentage of MGI scores of 0 or 1</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="4.52"/>
                    <measurement group_id="O2" value="27.5" spread="9.45"/>
                    <measurement group_id="O3" value="24.3" spread="8.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>Wilcoxon Rank Sum Test</method>
            <method_desc>P-values were based on Wilcoxon Rank Sum Test on the change from baseline.</method_desc>
            <param_type>Hodges-Lehmann estimate of difference</param_type>
            <param_value>23.240</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.75</ci_lower_limit>
            <ci_upper_limit>25.85</ci_upper_limit>
            <estimate_desc>95% Confidence limits for the location shift.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>Wilcoxon Rank Sum Test</method>
            <method_desc>P-values were based on Wilcoxon Rank Sum Test on the change from baseline.</method_desc>
            <param_type>Hodges-Lehmann estimate of difference</param_type>
            <param_value>19.444</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.09</ci_lower_limit>
            <ci_upper_limit>22.22</ci_upper_limit>
            <estimate_desc>95% Confidence limits for the location shift.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3</title>
        <description>Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline in the percentage of sites with a PI score of 0 or 1 at Week 3.</description>
        <time_frame>Baseline to 3 Weeks</time_frame>
        <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Negative Control (W002194-221P)</title>
            <description>Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O2">
            <title>19292-116A</title>
            <description>Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O3">
            <title>11965-059</title>
            <description>Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3</title>
          <description>Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline in the percentage of sites with a PI score of 0 or 1 at Week 3.</description>
          <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>percentage of PI scores of 0 or 1</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="3.60"/>
                    <measurement group_id="O2" value="20.9" spread="10.76"/>
                    <measurement group_id="O3" value="18.3" spread="9.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>Wilcoxon Rank Sum Test</method>
            <method_desc>P-values were based on Wilcoxon Rank Sum Test on the change from baseline.</method_desc>
            <param_type>Hodges-Lehmann estimate of difference</param_type>
            <param_value>19.048</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.94</ci_lower_limit>
            <ci_upper_limit>21.73</ci_upper_limit>
            <estimate_desc>95% Confidence limits for the location shift.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>Wilcoxon Rank Sum Test</method>
            <method_desc>P-values were based on Wilcoxon Rank Sum Test on the change from baseline.</method_desc>
            <param_type>Hodges-Lehmann estimate of difference</param_type>
            <param_value>15.939</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.50</ci_lower_limit>
            <ci_upper_limit>18.67</ci_upper_limit>
            <estimate_desc>95% Confidence limits for the location shift.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3</title>
        <description>Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was the change from baseline in the percentage of sites with a BI score of 0 at Week 3.</description>
        <time_frame>Baseline to 3 Weeks</time_frame>
        <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Negative Control (W002194-221P)</title>
            <description>Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O2">
            <title>19292-116A</title>
            <description>Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O3">
            <title>11965-059</title>
            <description>Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3</title>
          <description>Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was the change from baseline in the percentage of sites with a BI score of 0 at Week 3.</description>
          <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>percentage of BI scores of 0</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="2.30"/>
                    <measurement group_id="O2" value="2.5" spread="2.66"/>
                    <measurement group_id="O3" value="2.1" spread="3.17"/>
                  </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_list>
            <groups_desc>The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>Wilcoxon Rank Sum Test</method>
            <method_desc>P-values were based on Wilcoxon Rank Sum Test on the change from baseline.</method_desc>
            <param_type>Hodges-Lehmann estimate of difference</param_type>
            <param_value>2.050</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.30</ci_lower_limit>
            <ci_upper_limit>2.78</ci_upper_limit>
            <estimate_desc>95% Confidence limits for the location shift.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>Wilcoxon Rank Sum Test</method>
            <method_desc>P-values were based on Wilcoxon Rank Sum Test on the change from baseline.</method_desc>
            <param_type>Hodges-Lehmann estimate of difference</param_type>
            <param_value>1.190</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.93</ci_lower_limit>
            <ci_upper_limit>2.06</ci_upper_limit>
            <estimate_desc>95% Confidence limits for the location shift.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3</title>
        <description>Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with an MGI score ≥3 at Week 3.</description>
        <time_frame>Baseline to 3 Weeks</time_frame>
        <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Negative Control (W002194-221P)</title>
            <description>Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O2">
            <title>19292-116A</title>
            <description>Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O3">
            <title>11965-059</title>
            <description>Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3</title>
          <description>Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with an MGI score ≥3 at Week 3.</description>
          <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>percentage of MGI scores of &gt;= 3</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="4.34"/>
                    <measurement group_id="O2" value="0.9" spread="4.15"/>
                    <measurement group_id="O3" value="0.3" spread="3.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.016</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>Wilcoxon Rank Sum Test</method>
            <method_desc>P-values were based on Wilcoxon Rank Sum Test on the change from baseline.</method_desc>
            <param_type>Hodges-Lehmann estimate of difference</param_type>
            <param_value>1.316</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>2.78</ci_upper_limit>
            <estimate_desc>95% Confidence limits for the location shift.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.197</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>Wilcoxon Rank Sum Test</method>
            <method_desc>P-values were based on Wilcoxon Rank Sum Test on the change from baseline.</method_desc>
            <param_type>Hodges-Lehmann estimate of difference</param_type>
            <param_value>0.926</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.16</ci_lower_limit>
            <ci_upper_limit>1.85</ci_upper_limit>
            <estimate_desc>95% Confidence limits for the location shift.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3</title>
        <description>Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥3 at Week 3.</description>
        <time_frame>Baseline to 3 Weeks</time_frame>
        <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Negative Control (W002194-221P)</title>
            <description>Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O2">
            <title>19292-116A</title>
            <description>Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O3">
            <title>11965-059</title>
            <description>Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3</title>
          <description>Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥3 at Week 3.</description>
          <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>percentage of PI scores of &gt;= 3</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="13.12"/>
                    <measurement group_id="O2" value="23.5" spread="14.45"/>
                    <measurement group_id="O3" value="18.9" spread="13.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>Wilcoxon Rank Sum Test</method>
            <method_desc>P-values were based on Wilcoxon Rank Sum Test on the change from baseline.</method_desc>
            <param_type>Hodges-Lehmann estimate of difference</param_type>
            <param_value>23.214</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>18.21</ci_lower_limit>
            <ci_upper_limit>28.77</ci_upper_limit>
            <estimate_desc>95% Confidence limits for the location shift.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>Wilcoxon Rank Sum Test</method>
            <method_desc>P-values were based on Wilcoxon Rank Sum Test on the change from baseline.</method_desc>
            <param_type>Hodges-Lehmann estimate of difference</param_type>
            <param_value>18.590</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.69</ci_lower_limit>
            <ci_upper_limit>23.81</ci_upper_limit>
            <estimate_desc>95% Confidence limits for the location shift.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3</title>
        <description>Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥2 at Week 3.</description>
        <time_frame>Baseline to 3 Weeks</time_frame>
        <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Negative Control (W002194-221P)</title>
            <description>Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O2">
            <title>19292-116A</title>
            <description>Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
          <group group_id="O3">
            <title>11965-059</title>
            <description>Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3</title>
          <description>Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥2 at Week 3.</description>
          <population>Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>percentage of PI scores of &gt;= 2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="3.60"/>
                    <measurement group_id="O2" value="20.9" spread="10.76"/>
                    <measurement group_id="O3" value="18.3" spread="9.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>Wilcoxon Rank Sum Test</method>
            <method_desc>P-values were based on Wilcoxon Rank Sum Test on the change from baseline.</method_desc>
            <param_type>Hodges-Lehmann estimate of difference</param_type>
            <param_value>19.048</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.94</ci_lower_limit>
            <ci_upper_limit>21.73</ci_upper_limit>
            <estimate_desc>95% Confidence limits for the location shift.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>Wilcoxon Rank Sum Test</method>
            <method_desc>P-values were based on Wilcoxon Rank Sum Test on the change from baseline.</method_desc>
            <param_type>Hodges-Lehmann estimate of difference</param_type>
            <param_value>15.939</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.50</ci_lower_limit>
            <ci_upper_limit>18.67</ci_upper_limit>
            <estimate_desc>95% Confidence limits for the location shift.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 22 ± 2 days, + 30 days for serious adverse events.</time_frame>
      <desc>Adverse events were systematically collected at each study visit through Visit 3 (Day 22 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.</desc>
      <group_list>
        <group group_id="E1">
          <title>Negative Control (W002194-221P)</title>
          <description>Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing</description>
        </group>
        <group group_id="E2">
          <title>19292-116A</title>
          <description>Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing</description>
        </group>
        <group group_id="E3">
          <title>11965-059</title>
          <description>Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing</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="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <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>Principal investigator agreed not to publish the study results without prior sponsor approval.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael Lynch, DMD, PhD/Study Director</name_or_title>
      <organization>Johnson &amp; Johnson Consumer and Personal Products Worldwide</organization>
      <phone>908-433-6423 USA EST</phone>
      <email>mlynch23@its.jnj.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/NCT02233998
org study id: CO-140508133810-OCCT
nct id: NCT02233998
lead sponsor: 
has dmc: No
The reduction of existing plaque and gum inflammation will be evaluated using two marketed
      mouth rinses along with tooth brushing after 21 days of use compared to a placebo mouth
      rinse.

      165 healthy volunteers will be enrolled in this three week study. Volunteers who qualify to
      be in this study will have an equal chance of being assigned to one of the three treatment
      groups. Volunteers will have a total of three visits including 1) Screening/Baseline Day 1 2)
      Day 11 (after 10 days of use) and 3) Day 22 (after 21 days of use). Volunteers will maintain
      a diary at home to record each treatment use and will be asked to come to the clinic without
      brushing or use their product for at least 8 hours, but no more than 18 hours. Examinations
      for oral hard/soft tissue, gingivitis, bleeding and plaque assessments will be completed at
      Screening/Baseline and repeated at Clinic Visit 3, which is Day 22.
A sufficient number of generally healthy subjects (approximately 165) that meet the required
      inclusion/exclusion criteria will be enrolled in this 21 day, examiner-blind, single center,
      randomized, parallel-group controlled clinical trial to ensure that at least 150 subjects (50
      per treatment group) complete this study.

      At baseline, the prescreened subjects will present to the clinic site for baseline
      examinations (oral tissue assessment, gingivitis, bleeding and plaque assessments) having
      refrained from oral hygiene for at least 8 hours, but no more than 18 hours. After the
      baseline oral examinations, assessment of other inclusion/exclusion criteria qualifying
      subjects will be randomly assigned to one of three treatment groups. Immediately following
      this randomization, subjects will begin use of their assigned test product following the
      label instructions. If randomized to the control group, subjects will brush twice daily in
      their usual manner with an ADA accepted fluoride toothpaste and a soft bristled toothbrush
      followed by rinsing twice daily with a 5% hydroalcohol control rinse (W002194-221P). If
      randomized to an active treatment group; subjects will brush twice daily in their usual
      manner, followed by rinsing twice daily with their assigned mouth rinse formulation
      (19292-116A or 11965-059). Subjects will be instructed to follow label instructions 20ml for
      30 seconds twice daily for mouth rinse product. The first product use will be conducted under
      the supervision of study personnel. All other brushing and rinsing will be unsupervised and
      the subjects will be required to maintain a diary card to document twice daily product use,
      brushing and rinsing times. Compliance will be evaluated by weighing residual volumes of
      returned mouth rinse and by reviewing the subject diary. Subjects will receive an ADA-
      accepted fluoride-containing dentifrice and a soft bristled toothbrush at their baseline
      visit.

      Subjects may continue to use floss to remove impacted food between the teeth if it is part of
      their usual oral care regimen during the course of the study; no other oral hygiene
      procedures will be permitted, including teeth cleaning, whitening or dental procedures except
      for an emergency treatment. The decision to withdraw a subject due to emergency dental
      treatment will occur at the discretion of the Investigator.

      At baseline and three weeks (±2 days) visits, subject will not have brushed or have used
      their product for at least 8 hours, but no more than 18 hours.

      Oral tissue safety, Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI)
      will be assessed.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Investigator)
measure: Whole Mouth Mean Modified Gingival Index (MGI) at Week 3
time frame: 3 Weeks
description: Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.
measure: Whole Mouth Mean Plaque Index (PI) at Week 3
time frame: 3 Weeks
description: Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3.
measure: Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3
time frame: 3 Weeks
description: Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was calculated by averaging their tooth site scores at Week 3.
measure: Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3
time frame: Baseline to 3 Weeks
description: Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline in the percentage of sites with an MGI score of 0 or 1 at Week 3.
measure: Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3
time frame: Baseline to 3 Weeks
description: Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline in the percentage of sites with a PI score of 0 or 1 at Week 3.
measure: Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3
time frame: Baseline to 3 Weeks
description: Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was the change from baseline in the percentage of sites with a BI score of 0 at Week 3.
measure: Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3
time frame: Baseline to 3 Weeks
description: Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with an MGI score ≥3 at Week 3.
measure: Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3
time frame: Baseline to 3 Weeks
description: Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥3 at Week 3.
measure: Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3
time frame: Baseline to 3 Weeks
description: Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥2 at Week 3.
arm group label: Mouth Rinse 1
arm group type: Active Comparator
description: After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds.
arm group label: Mouth Rinse 2
arm group type: Active Comparator
description: After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds.
arm group label: Mouth Rinse 3
arm group type: Placebo Comparator
description: After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds.
intervention type: Other
intervention name: Mouth Rinse 1
arm group label: Mouth Rinse 1
other name: Cool Mint Listerine Antiseptic
intervention type: Other
intervention name: Mouth Rinse 2
arm group label: Mouth Rinse 2
other name: Listerine Zero
intervention type: Other
intervention name: Mouth Rinse 3
arm group label: Mouth Rinse 3
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Maher Naji, D.D.S
role: Principal Investigator
affiliation: All Sum Research Center Ltd.
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Gingivitis
mesh term: Listerine
mesh term: Sodium Fluoride
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 