<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/NCT02980497</url>
  </required_header>
  <id_info>
    <org_study_id>FCLGBP0056</org_study_id>
    <nct_id>NCT02980497</nct_id>
  </id_info>
  <brief_title>Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study</brief_title>
  <official_title>Determination of the Antiplaque/Antigingivitis Efficacy of Essential Oil Containing Mouthrinses In a Six-Month Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Consumer and Personal Products Worldwide</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Taubate</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johnson &amp; Johnson Consumer and Personal Products Worldwide</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this randomized, single-center, examiner-blind, controlled, parallel group,&#xD;
      six-month clinical study is to compare the antiplaque/antigingivitis potential of a&#xD;
      no-alcohol essential oil containing mouthrinse and an alcohol essential oil containing&#xD;
      mouthrinse. A negative control group using only an ADA Accepted anticavity toothpaste will be&#xD;
      included.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Modified Gingival Index (MGI) at 6 Months</measure>
    <time_frame>6 Months</time_frame>
    <description>Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Modified Gingival Index (MGI) at 1 Month</measure>
    <time_frame>1 Month</time_frame>
    <description>Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Modified Gingival Index (MGI) at 3 Months</measure>
    <time_frame>3 Months</time_frame>
    <description>Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Gingival Bleeding Index (BI) at 1 Month</measure>
    <time_frame>1 Month</time_frame>
    <description>Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Gingival Bleeding Index (BI) at 3 Months</measure>
    <time_frame>3 Months</time_frame>
    <description>Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Gingival Bleeding Index (BI) at 6 Months</measure>
    <time_frame>6 Months</time_frame>
    <description>Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 1 Month</measure>
    <time_frame>1 Month</time_frame>
    <description>Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 3 Months</measure>
    <time_frame>3 Months</time_frame>
    <description>Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 6 Months</measure>
    <time_frame>6 Months</time_frame>
    <description>Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">370</enrollment>
  <condition>Plaque</condition>
  <condition>Gingivitis</condition>
  <condition>Gum Inflammation</condition>
  <condition>Bleeding</condition>
  <arm_group>
    <arm_group_label>Listerine Zero Mouthwash (without alcohol)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brushing twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush and rinsing with 20 ml of Listerine Zero Mouthwash (without alcohol) for 30 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Listerine Antiseptic Mouthwash (with alcohol)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brushing twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush and rinsing with 20 ml of Listerine Antiseptic Mouthwash (with alcohol) for 30 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brush only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Brush only twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Listerine Zero Mouthwash (without alcohol)</intervention_name>
    <description>20 ml of rinse for 30 seconds, twice a day</description>
    <arm_group_label>Listerine Zero Mouthwash (without alcohol)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Listerine Antiseptic Mouthwash (with alcohol)</intervention_name>
    <description>20 ml of rinse for 30 seconds, twice a day</description>
    <arm_group_label>Listerine Antiseptic Mouthwash (with alcohol)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females 18 years of age or older, in good general and oral health, except&#xD;
             gingivitis.&#xD;
&#xD;
          2. 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;
          3. 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;
          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 ≥ 1.75 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;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of significant adverse effects, including sensitivities or suspected&#xD;
             allergies, following use of oral hygiene products such as toothpastes and mouthrinses&#xD;
             and red food dye.&#xD;
&#xD;
          2. History of serious medical conditions that, at the discretion of the Investigator,&#xD;
             will disqualify the subject.&#xD;
&#xD;
          3. History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions&#xD;
             requiring prophylactic antibiotic coverage prior to invasive dental procedures.&#xD;
&#xD;
          4. Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the&#xD;
             2 weeks prior to the baseline exam.&#xD;
&#xD;
          5. Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan,&#xD;
             essential oil, cetylpyridinium chloride, or chlorhexidine containing mouthrinses&#xD;
             within the 2 weeks prior to baseline.&#xD;
&#xD;
          6. Current or history of alcohol or drug abuse.&#xD;
&#xD;
          7. Self reported pregnancy or lactation (this is an exclusion criterion due to oral&#xD;
             tissue changes related to pregnancy and nursing which can affect interpretation of&#xD;
             study results).&#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>Jose Cortelli, Ph. D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade de Taubate</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sheila Cortelli, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Universidade de Taubate</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Taubate</name>
      <address>
        <city>Taubate</city>
        <state>Sao Paulo</state>
        <zip>12020-270</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mouthrinse</keyword>
  <keyword>plaque</keyword>
  <keyword>gingivitis</keyword>
  <keyword>gum bleeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Anti-Infective Agents, Local</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02980497
org study id: FCLGBP0056
nct id: NCT02980497
lead sponsor: 
collaborator: 
has dmc: No
The objective of this randomized, single-center, examiner-blind, controlled, parallel group,
      six-month clinical study is to compare the antiplaque/antigingivitis potential of a
      no-alcohol essential oil containing mouthrinse and an alcohol essential oil containing
      mouthrinse. A negative control group using only an ADA Accepted anticavity toothpaste will be
      included.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Mean Modified Gingival Index (MGI) at 6 Months
time frame: 6 Months
description: Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.
measure: Mean Modified Gingival Index (MGI) at 1 Month
time frame: 1 Month
description: Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.
measure: Mean Modified Gingival Index (MGI) at 3 Months
time frame: 3 Months
description: Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.
measure: Mean Gingival Bleeding Index (BI) at 1 Month
time frame: 1 Month
description: Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.
measure: Mean Gingival Bleeding Index (BI) at 3 Months
time frame: 3 Months
description: Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.
measure: Mean Gingival Bleeding Index (BI) at 6 Months
time frame: 6 Months
description: Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.
measure: Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 1 Month
time frame: 1 Month
description: Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.
measure: Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 3 Months
time frame: 3 Months
description: Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.
measure: Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 6 Months
time frame: 6 Months
description: Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.
arm group label: Listerine Zero Mouthwash (without alcohol)
arm group type: Active Comparator
description: Brushing twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush and rinsing with 20 ml of Listerine Zero Mouthwash (without alcohol) for 30 seconds.
arm group label: Listerine Antiseptic Mouthwash (with alcohol)
arm group type: Active Comparator
description: Brushing twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush and rinsing with 20 ml of Listerine Antiseptic Mouthwash (with alcohol) for 30 seconds.
arm group label: Brush only
arm group type: No Intervention
description: Brush only twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush.
intervention type: Other
intervention name: Listerine Zero Mouthwash (without alcohol)
description: 20 ml of rinse for 30 seconds, twice a day
arm group label: Listerine Zero Mouthwash (without alcohol)
intervention type: Other
intervention name: Listerine Antiseptic Mouthwash (with alcohol)
description: 20 ml of rinse for 30 seconds, twice a day
arm group label: Listerine Antiseptic Mouthwash (with alcohol)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jose Cortelli, Ph. D
role: Principal Investigator
affiliation: Universidade de Taubate
last name: Sheila Cortelli, Ph.D
role: Study Chair
affiliation: Universidade de Taubate
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Gingivitis
mesh term: Inflammation
mesh term: Hemorrhage
mesh term: Ethanol
mesh term: Listerine
mesh term: Anti-Infective Agents, Local
mesh term: Sodium Fluoride
sharing ipd: No