<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/NCT04449952</url>
  </required_header>
  <id_info>
    <org_study_id>CCSORC002281</org_study_id>
    <secondary_id>CCSORC002281</secondary_id>
    <nct_id>NCT04449952</nct_id>
  </id_info>
  <brief_title>A Study of Mouth Rinses in Type 1 and Type 2 Diabetic Participants</brief_title>
  <official_title>Safety and Clinical Efficacy of Mouth Rinses in Type 1 and Type 2 Diabetics: Effect on Oral Soft Tissue, Plaque and Gingivitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Consumer Inc. (J&amp;JCI)</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate mouth rinse formulations for oral soft tissue&#xD;
      tolerance and efficacy in plaque/ gingivitis prevention/reduction in Type 1 and Type 2&#xD;
      diabetics when used twice daily as an adjunct to tooth brushing during a twelve-week&#xD;
      treatment period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2019</start_date>
  <completion_date type="Actual">March 6, 2020</completion_date>
  <primary_completion_date type="Actual">March 6, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Whole-Mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Whole Mouth Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Whole Mouth Mean Turesky Plaque Index (TPI) Score After 1 and 6 Weeks of Product use</measure>
    <time_frame>1 Week and 6 Weeks</time_frame>
    <description>Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole-Mouth Mean Modified Gingival Index (MGI) Score After 6 Weeks of Product use</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole-Mouth Mean Expanded Bleeding Index (EBI) Score After 6 and 12 Weeks of Product use</measure>
    <time_frame>6 Weeks and 12 Weeks</time_frame>
    <description>Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 millimeter (mm) diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0 (Absence of bleeding after 30 seconds); 1 (Bleeding after 30 seconds); 2 (Immediate bleeding).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index Score After 6 and 12 Weeks of Product use</measure>
    <time_frame>6 Weeks and 12 Weeks</time_frame>
    <description>Percent bleeding sites will be calculated by taking the total number of sites with bleeding score greater than 0 divided by the total number of sites assessed for each participant. Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 millimeter (mm) diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0 (Absence of bleeding after 30 seconds); 1 (Bleeding after 30 seconds); 2 (Immediate bleeding).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Gingivits in Diabetics</condition>
  <arm_group>
    <arm_group_label>AFEO-Containing Mouth Rinse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with Diabetes (Type 1 and 2) will be randomized to receive AFEO-containing mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 milliliter (mL) of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Listerine Cool Mint Mouth Rinse (Marketed product)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with Diabetes (Type 1 and 2) will be randomized to receive Listerine cool mint mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 mL of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 Percent (%) Hydroalcohol Mouth Rinse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with Diabetes (Type 1 and 2) will be randomized to receive 5% Hydroalcohol mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 mL of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Listerine Cool Mint</intervention_name>
    <description>Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing</description>
    <arm_group_label>Listerine Cool Mint Mouth Rinse (Marketed product)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>5% Hydroalcohol Mouth Rinse</intervention_name>
    <description>Participants use 20 mL of 5% Hydroalcohol mouth rinse for 30 sec after brushing.</description>
    <arm_group_label>5 Percent (%) Hydroalcohol Mouth Rinse</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Colgate Cavity Protection Toothpaste</intervention_name>
    <description>Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.</description>
    <arm_group_label>5 Percent (%) Hydroalcohol Mouth Rinse</arm_group_label>
    <arm_group_label>AFEO-Containing Mouth Rinse</arm_group_label>
    <arm_group_label>Listerine Cool Mint Mouth Rinse (Marketed product)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead Formula</intervention_name>
    <description>Participants use 20 mL of AFEO mouth rinse lead formula for 30 sec after brushing.</description>
    <arm_group_label>AFEO-Containing Mouth Rinse</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Concept Curve Winter Series Toothbrush</intervention_name>
    <description>Participants will brush teeth at least one minute with provided bristled toothbrush.</description>
    <arm_group_label>5 Percent (%) Hydroalcohol Mouth Rinse</arm_group_label>
    <arm_group_label>AFEO-Containing Mouth Rinse</arm_group_label>
    <arm_group_label>Listerine Cool Mint Mouth Rinse (Marketed product)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Listerine Cool Mint Floss</intervention_name>
    <description>Participants will use marketed fluoride-containing dentifrice, floss.</description>
    <arm_group_label>5 Percent (%) Hydroalcohol Mouth Rinse</arm_group_label>
    <arm_group_label>AFEO-Containing Mouth Rinse</arm_group_label>
    <arm_group_label>Listerine Cool Mint Mouth Rinse (Marketed product)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect)&#xD;
&#xD;
          -  Able to comprehend and follow the requirements and restrictions of the study&#xD;
             (including willingness to use the assigned study products per instructions,&#xD;
             availability on scheduled visit dates and likeliness of completing the clinical study)&#xD;
             based upon research site personnel's assessment&#xD;
&#xD;
          -  Negative pregnancy urine tests (females of child bearing potential only)&#xD;
&#xD;
          -  Females of childbearing potential must be using a medically-acceptable method of birth&#xD;
             control for at least one month prior to Visit 1 and agree to continue using this&#xD;
             method during their participation in the study&#xD;
&#xD;
          -  A minimum of 20 gradable teeth including 4 molars with scorable both facial and&#xD;
             lingual surfaces.Teeth that are grossly carious, extensively restored, orthodontically&#xD;
             banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion,&#xD;
             teeth with veneers, or third molars will not be included in the tooth count&#xD;
&#xD;
          -  Diabetes Type 1 or Type 2-self reported&#xD;
&#xD;
          -  An HB A1C level less than (&lt;) 7.0 percent (%) for Type 1 Diabetes and an HB A1C level&#xD;
             of &lt;8.0% for Type 2 Diabetes&#xD;
&#xD;
          -  A mean gingival index greater than or equal to (&gt;=) 1.85 per the Modified Gingival&#xD;
             Index at Baseline&#xD;
&#xD;
          -  A mean plaque index &gt;= 1.95 per the 6 site Turesky modification of the Quigley-Hein&#xD;
             Plaque Index at Baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dental prophylaxis within four weeks prior to baseline visit&#xD;
&#xD;
          -  More than 3 sites having pocket depths of 5 millimeter (mm) or any sites that are&#xD;
             greater than 5 mm in depth&#xD;
&#xD;
          -  History of medical conditions requiring prophylactic antibiotic coverage prior to&#xD;
             invasive dental procedures&#xD;
&#xD;
          -  A recent history of hypoglycemia requiring medical intervention within the past 30&#xD;
             days&#xD;
&#xD;
          -  Use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or&#xD;
             diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/&#xD;
             immunomodulators during the study or within the one month prior to the Baseline exam.&#xD;
             Intermittent use of certain anti-inflammatory medication is acceptable at the&#xD;
             discretion of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffery Milleman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Salus Research, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Salus Research, Inc.</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&amp;amp;parentIdentifier=CCSORC002281&amp;amp;attachmentIdentifier=8eb8187b-9c2f-4e13-bb1f-7fc737874806&amp;amp;fileName=Diabetes___CCSORC002281___Final_CSR___Redacted_Version_PDFa.pdf&amp;amp;versionIdentifier=</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Leite RS, Marlow NM, Fernandes JK, Hermayer K. Oral health and type 2 diabetes. Am J Med Sci. 2013 Apr;345(4):271-273. doi: 10.1097/MAJ.0b013e31828bdedf.</citation>
    <PMID>23531957</PMID>
  </reference>
  <reference>
    <citation>Qaseem A, Wilt TJ, Kansagara D, Horwitch C, Barry MJ, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Fitterman N, Balzer K, Boyd C, Humphrey LL, Iorio A, Lin J, Maroto M, McLean R, Mustafa R, Tufte J. Hemoglobin A1c Targets for Glycemic Control With Pharmacologic Therapy for Nonpregnant Adults With Type 2 Diabetes Mellitus: A Guidance Statement Update From the American College of Physicians. Ann Intern Med. 2018 Apr 17;168(8):569-576. doi: 10.7326/M17-0939. Epub 2018 Mar 6.</citation>
    <PMID>29507945</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>August 4, 2023</last_update_submitted>
  <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Johnson &amp; Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.</ipd_description>
    <ipd_url>http://yoda.yale.edu</ipd_url>
  </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/NCT04449952
org study id: CCSORC002281
secondary id: CCSORC002281
nct id: NCT04449952
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate mouth rinse formulations for oral soft tissue
      tolerance and efficacy in plaque/ gingivitis prevention/reduction in Type 1 and Type 2
      diabetics when used twice daily as an adjunct to tooth brushing during a twelve-week
      treatment period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Care Provider)
measure: Whole-Mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
time frame: 12 Weeks
description: Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit).
measure: Whole Mouth Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
time frame: 12 Weeks
description: Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).
measure: Whole Mouth Mean Turesky Plaque Index (TPI) Score After 1 and 6 Weeks of Product use
time frame: 1 Week and 6 Weeks
description: Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).
measure: Whole-Mouth Mean Modified Gingival Index (MGI) Score After 6 Weeks of Product use
time frame: 6 Weeks
description: Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit).
measure: Whole-Mouth Mean Expanded Bleeding Index (EBI) Score After 6 and 12 Weeks of Product use
time frame: 6 Weeks and 12 Weeks
description: Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 millimeter (mm) diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0 (Absence of bleeding after 30 seconds); 1 (Bleeding after 30 seconds); 2 (Immediate bleeding).
measure: Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index Score After 6 and 12 Weeks of Product use
time frame: 6 Weeks and 12 Weeks
description: Percent bleeding sites will be calculated by taking the total number of sites with bleeding score greater than 0 divided by the total number of sites assessed for each participant. Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 millimeter (mm) diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0 (Absence of bleeding after 30 seconds); 1 (Bleeding after 30 seconds); 2 (Immediate bleeding).
arm group label: AFEO-Containing Mouth Rinse
arm group type: Experimental
description: Participants with Diabetes (Type 1 and 2) will be randomized to receive AFEO-containing mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 milliliter (mL) of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.
arm group label: Listerine Cool Mint Mouth Rinse (Marketed product)
arm group type: Experimental
description: Participants with Diabetes (Type 1 and 2) will be randomized to receive Listerine cool mint mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 mL of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.
arm group label: 5 Percent (%) Hydroalcohol Mouth Rinse
arm group type: Experimental
description: Participants with Diabetes (Type 1 and 2) will be randomized to receive 5% Hydroalcohol mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 mL of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.
intervention type: Other
intervention name: Listerine Cool Mint
description: Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing
arm group label: Listerine Cool Mint Mouth Rinse (Marketed product)
intervention type: Other
intervention name: 5% Hydroalcohol Mouth Rinse
description: Participants use 20 mL of 5% Hydroalcohol mouth rinse for 30 sec after brushing.
arm group label: 5 Percent (%) Hydroalcohol Mouth Rinse
intervention type: Other
intervention name: Colgate Cavity Protection Toothpaste
description: Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
arm group label: 5 Percent (%) Hydroalcohol Mouth Rinse
arm group label: AFEO-Containing Mouth Rinse
arm group label: Listerine Cool Mint Mouth Rinse (Marketed product)
intervention type: Other
intervention name: Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead Formula
description: Participants use 20 mL of AFEO mouth rinse lead formula for 30 sec after brushing.
arm group label: AFEO-Containing Mouth Rinse
intervention type: Device
intervention name: Concept Curve Winter Series Toothbrush
description: Participants will brush teeth at least one minute with provided bristled toothbrush.
arm group label: 5 Percent (%) Hydroalcohol Mouth Rinse
arm group label: AFEO-Containing Mouth Rinse
arm group label: Listerine Cool Mint Mouth Rinse (Marketed product)
intervention type: Device
intervention name: Listerine Cool Mint Floss
description: Participants will use marketed fluoride-containing dentifrice, floss.
arm group label: 5 Percent (%) Hydroalcohol Mouth Rinse
arm group label: AFEO-Containing Mouth Rinse
arm group label: Listerine Cool Mint Mouth Rinse (Marketed product)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffery Milleman
role: Principal Investigator
affiliation: Salus Research, Inc.
facility: 
country: United States
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&amp;parentIdentifier=CCSORC002281&amp;attachmentIdentifier=8eb8187b-9c2f-4e13-bb1f-7fc737874806&amp;fileName=Diabetes___CCSORC002281___Final_CSR___Redacted_Version_PDFa.pdf&amp;versionIdentifier=
description: Related Info
citation: Leite RS, Marlow NM, Fernandes JK, Hermayer K. Oral health and type 2 diabetes. Am J Med Sci. 2013 Apr;345(4):271-273. doi: 10.1097/MAJ.0b013e31828bdedf.
PMID: 23531957
citation: Qaseem A, Wilt TJ, Kansagara D, Horwitch C, Barry MJ, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Fitterman N, Balzer K, Boyd C, Humphrey LL, Iorio A, Lin J, Maroto M, McLean R, Mustafa R, Tufte J. Hemoglobin A1c Targets for Glycemic Control With Pharmacologic Therapy for Nonpregnant Adults With Type 2 Diabetes Mellitus: A Guidance Statement Update From the American College of Physicians. Ann Intern Med. 2018 Apr 17;168(8):569-576. doi: 10.7326/M17-0939. Epub 2018 Mar 6.
PMID: 29507945
responsible party type: Sponsor
mesh term: Listerine
mesh term: Sodium Fluoride
sharing ipd: Yes
ipd description: Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
ipd url: http://yoda.yale.edu