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A Clinical Trial to Test the Effect of an Experimental Mouth Rinse on Gum Disease

Primary Purpose

Gingivitis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mouth Rinse 19668-012
Mouth Rinse 500347078842
Toothpaste 035000513007
Sponsored by
Johnson & Johnson Consumer Inc. (J&JCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gingivitis focused on measuring Gums, Gingiva, Gingival Inflammation, Gingival Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Assessed by site personnel as able to comprehend and follow the requirements of the study in the Portuguese language, and to be available on scheduled visit dates
  • After being informed of all pertinent aspects of the trial, and having all questions answered, voluntarily signed an informed consent document
  • Assessed by the investigator to have gingivitis, and otherwise qualify to be a participant in the trial

Exclusion Criteria:

  • Relative, partner or staff of any clinical research site personnel
  • Any oral, psychiatric or medical condition (including pregnancy or nursing), laboratory abnormality, or use of experimental or other products that may (per protocol or in the opinion of the investigator) compromise the safety of the participant or the interpretation of study results

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Other

    Arm Label

    Mouth Rinse 19668-012

    Mouth Rinse 500347078842

    Toothpaste 035000513007

    Arm Description

    Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner, rinse mouth with water, and then rinse with 20 ml of mouth rinse 19668-012 for 30 seconds and spit it out - do not swallow.

    Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner, rinse mouth with water, and then rinse with 10 ml of mouth rinse 500347078842 for 60 seconds and spit it out - do not swallow. Attention: Toothpastes can stop mouth rinse from working. Rinse your mouth thoroughly with water and wait 5 minutes after brushing your teeth before using the mouth rinse. You can also use the mouthwash at a different time of day.

    Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner. Subjects in this arm will not use any mouth rinse.

    Outcomes

    Primary Outcome Measures

    Whole-mouth Mean Bleeding Index (BI) at 3 Months
    Bleeding after periodontal probe will be assessed by scores on a scale of 0-2 using the Gingival Bleeding Index (BI), where 0=Absence of Bleeding after 30 Seconds and 2=Immediate Bleeding.

    Secondary Outcome Measures

    Whole-mouth Mean Bleeding Index (BI)
    Bleeding after periodontal probe will be assessed by scores on a scale of 0-2 using the Gingival Bleeding Index (BI), where 0=Absence of Bleeding after 30 Seconds and 2=Immediate Bleeding.
    Whole-mouth Mean Modified Gingival Index (MGI)
    Gingivitis will be assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index, where 0=Normal and 4=Severe Inflammation.
    Whole Mouth Mean Plaque Index (PI)
    Plaque will be assessed on a scale of 0-5 using the Turesky modification of the Quigley-Hein Plaque Index, where 0=No plaque and 5=Plaque covering 2/3 or more of surface.
    Mean Area Stain Score for Mesial Region
    A mean area stain score for the Mesial Region will be recorded on a scale of 0-3, where 0 = no stain present, natural tooth color and 3 = stain outside pits/grooves, over 10% of surface affected
    Mean Area Stain Score for Gingival Region
    A mean area stain score will be recorded for Gingival Region, on a scale of 0-3, where 0 = no stain present, natural tooth color and 3 = stain outside pits/grooves, over 10% of surface affected
    Mean Area Stain Score for Distal Region
    A mean area stain score will be recorded for Distal Region, on a scale of 0-3, where 0 = no stain present, natural tooth color and 3 = stain outside pits/grooves, over 10% of surface affected
    Mean Area Stain Score for Body of Tooth
    Mean area stain scores will be recorded for Body of Tooth, on a scale of 0-3, where 0 = no stain present, natural tooth color and 3 = stain outside pits/grooves, over 10% of surface affected
    Mean Stain Intensity Score
    A score for stain intensity will be recorded on a scale of 0-3, where 0 = no stain and 3 = heavy, dark stain (obvious and aesthetically unacceptable)
    Mean Tartar Height
    Mean tartar height will be recorded in millimeters

    Full Information

    First Posted
    March 22, 2013
    Last Updated
    January 25, 2019
    Sponsor
    Johnson & Johnson Consumer Inc. (J&JCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01821261
    Brief Title
    A Clinical Trial to Test the Effect of an Experimental Mouth Rinse on Gum Disease
    Official Title
    Three Month Clinical Efficacy of an Ethyl Lauroyl Arginate HCL (LAE) Mouth Rinse: Effect on Gingivitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business Decision
    Study Start Date
    April 30, 2014 (Actual)
    Primary Completion Date
    April 30, 2014 (Anticipated)
    Study Completion Date
    July 31, 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johnson & Johnson Consumer Inc. (J&JCI)

    4. Oversight

    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Subjects will be given special instructions about eating, smoking and taking care of their teeth during the 18 hours before they come to the dentist's office for screening. At that first visit, they will be examined by a dentist, who will examine their mouths with a dental instrument to determine whether they qualify to participate in the trial. Someone who works for the dentist will also take some oral measurements. Participants who qualify to be in the study will receive a treatment for their gingivitis and have an equal chance of being assigned to one of three treatment groups. Subjects in all three groups will be given toothpaste that is already available in stores. They will brush their teeth twice daily with a one-inch strip of toothpaste in their regular manner. After brushing, subjects in one group will use an experimental mouth rinse that is not available in stores. Another group will be given a mouth rinse to use that is already available in stores, and the third group will not use any mouth rinse at all. After they receive their assigned products subjects will be supervised while they brush their teeth and/or rinse to ensure they understand exactly how to use the products. All other brushing and rinsing over the next three months will be at home, but subjects will be required to keep a diary to record their brushing and rinsing times twice each day. Subjects will be required to bring their diaries and any leftover toothpaste and mouth rinse with them for four more scheduled appointments after about 1 week, 2 weeks, 4 weeks, and 3 months. At those appointments, the dentist will examine their mouths, make sure there are no safety concerns, and examine again to get the measurements needed. One of the dentist's staff members will take other measurements as well. The study will determine the measured effects of the experimental mouth rinse on gingivitis, and compare these results to the mouth rinse that is already available, as well as to using no mouth rinse at all.
    Detailed Description
    At screening/baseline, subjects will present to the clinical site having refrained from oral hygiene for at least 8 hours, but no more than 18 hours, and from eating or smoking for at least 4 hours for baseline examinations. Baseline examinations will include Macpherson modification of the Lobene Stain Index (Extrinsic Stain), Volpe-Manhold Index (Calculus), and oral hard and soft tissue exam, Modified Gingival Index (MGI), Bleeding Index (BI) and Plaque Index (PI). After the baseline oral examinations, subjects who qualify will receive a whole-mouth supragingival dental prophylaxis and random assignment to one of three treatment groups. Subjects randomized to the control group will brush twice daily with a marketed fluoride toothpaste. Subjects randomized to the experimental group will brush twice daily with a marketed fluoride toothpaste and use an experimental mouth rinse. The last randomized group will brush twice daily with a marketed fluoride toothpaste and rinse with a marketed mouth rinse twice daily. The first product use will be conducted under 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, with brushing and rinsing times. Diaries along with product accountability will be used to check for subject compliance. Subjects will return to the clinical site after one week (Day 7±1 day), two weeks (Day 14±2 days), four weeks (Day 28±3 days) and three months (Day 91±5 days). Oral hard and soft tissue safety, MGI, BI, and PI will be assessed at all visits. Extrinsic Stain and Calculus will be assessed at baseline, four weeks and three months by a different examiner. At the end of the study, subjects will return all used and unused product to the clinical site.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingivitis
    Keywords
    Gums, Gingiva, Gingival Inflammation, Gingival Bleeding

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mouth Rinse 19668-012
    Arm Type
    Experimental
    Arm Description
    Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner, rinse mouth with water, and then rinse with 20 ml of mouth rinse 19668-012 for 30 seconds and spit it out - do not swallow.
    Arm Title
    Mouth Rinse 500347078842
    Arm Type
    Active Comparator
    Arm Description
    Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner, rinse mouth with water, and then rinse with 10 ml of mouth rinse 500347078842 for 60 seconds and spit it out - do not swallow. Attention: Toothpastes can stop mouth rinse from working. Rinse your mouth thoroughly with water and wait 5 minutes after brushing your teeth before using the mouth rinse. You can also use the mouthwash at a different time of day.
    Arm Title
    Toothpaste 035000513007
    Arm Type
    Other
    Arm Description
    Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner. Subjects in this arm will not use any mouth rinse.
    Intervention Type
    Device
    Intervention Name(s)
    Mouth Rinse 19668-012
    Intervention Description
    20 ml of experimental mouth rinse 19668-012 for 30 seconds, twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    Mouth Rinse 500347078842
    Other Intervention Name(s)
    Mouth rinse containing Chlorhexidine, Corsodyl Mouthwash
    Intervention Description
    10 ml of mouth rinse 500347078842 for 60 seconds, twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    Toothpaste 035000513007
    Other Intervention Name(s)
    Toothpaste containing fluoride, Colgate® Cavity Protection Regular
    Intervention Description
    Approximately one inch of toothpaste 035000513007, twice daily
    Primary Outcome Measure Information:
    Title
    Whole-mouth Mean Bleeding Index (BI) at 3 Months
    Description
    Bleeding after periodontal probe will be assessed by scores on a scale of 0-2 using the Gingival Bleeding Index (BI), where 0=Absence of Bleeding after 30 Seconds and 2=Immediate Bleeding.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Whole-mouth Mean Bleeding Index (BI)
    Description
    Bleeding after periodontal probe will be assessed by scores on a scale of 0-2 using the Gingival Bleeding Index (BI), where 0=Absence of Bleeding after 30 Seconds and 2=Immediate Bleeding.
    Time Frame
    within 4 weeks
    Title
    Whole-mouth Mean Modified Gingival Index (MGI)
    Description
    Gingivitis will be assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index, where 0=Normal and 4=Severe Inflammation.
    Time Frame
    within 3 months
    Title
    Whole Mouth Mean Plaque Index (PI)
    Description
    Plaque will be assessed on a scale of 0-5 using the Turesky modification of the Quigley-Hein Plaque Index, where 0=No plaque and 5=Plaque covering 2/3 or more of surface.
    Time Frame
    within 3 months
    Title
    Mean Area Stain Score for Mesial Region
    Description
    A mean area stain score for the Mesial Region will be recorded on a scale of 0-3, where 0 = no stain present, natural tooth color and 3 = stain outside pits/grooves, over 10% of surface affected
    Time Frame
    within 3 months
    Title
    Mean Area Stain Score for Gingival Region
    Description
    A mean area stain score will be recorded for Gingival Region, on a scale of 0-3, where 0 = no stain present, natural tooth color and 3 = stain outside pits/grooves, over 10% of surface affected
    Time Frame
    within 3 months
    Title
    Mean Area Stain Score for Distal Region
    Description
    A mean area stain score will be recorded for Distal Region, on a scale of 0-3, where 0 = no stain present, natural tooth color and 3 = stain outside pits/grooves, over 10% of surface affected
    Time Frame
    within 3 months
    Title
    Mean Area Stain Score for Body of Tooth
    Description
    Mean area stain scores will be recorded for Body of Tooth, on a scale of 0-3, where 0 = no stain present, natural tooth color and 3 = stain outside pits/grooves, over 10% of surface affected
    Time Frame
    within 3 months
    Title
    Mean Stain Intensity Score
    Description
    A score for stain intensity will be recorded on a scale of 0-3, where 0 = no stain and 3 = heavy, dark stain (obvious and aesthetically unacceptable)
    Time Frame
    within 3 months
    Title
    Mean Tartar Height
    Description
    Mean tartar height will be recorded in millimeters
    Time Frame
    within 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Assessed by site personnel as able to comprehend and follow the requirements of the study in the Portuguese language, and to be available on scheduled visit dates After being informed of all pertinent aspects of the trial, and having all questions answered, voluntarily signed an informed consent document Assessed by the investigator to have gingivitis, and otherwise qualify to be a participant in the trial Exclusion Criteria: Relative, partner or staff of any clinical research site personnel Any oral, psychiatric or medical condition (including pregnancy or nursing), laboratory abnormality, or use of experimental or other products that may (per protocol or in the opinion of the investigator) compromise the safety of the participant or the interpretation of study results
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Lynch, DMD, PhD
    Organizational Affiliation
    Johnson & Johnson Consumer Inc. (J&JCI)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Clinical Trial to Test the Effect of an Experimental Mouth Rinse on Gum Disease

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