A Clinical Trial to Test the Effect of Experimental Mouth Rinse on Gum Disease
Participants will be given special instructions about taking care of their teeth during the 18 hours before they come to the dentist's office for screening/baseline, 1 week, 2 weeks and 4 weeks. 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. Participants in all three groups will be given toothpaste that is already available in stores. They will brush their teeth twice daily in their regular manner. After brushing, participants 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 use a placebo mouth rinse. After they receive their assigned products participants will be supervised while they brush their teeth and rinse to ensure they understand exactly how to use the products. Participants will be required to stay at the site 20 minutes after the first use of product during visit 1 to monitor any potential allergic reaction. All other brushing and rinsing over the next four weeks will be at home, but participants will be required to keep a diary to record their brushing and rinsing times twice each day.
Participants will be required to bring their diaries and any left-over toothpaste and mouth rinse with them for three more scheduled appointments after about 1 week, 2 weeks, and 4 weeks. 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 bleeding as a result of gingivitis, and compare these results to the mouth rinse that is already available.
|Gingivitis||Other: Listerine Advance Gum Defense Other: Mouth rinse containing Chlorhexidine Other: Mouth rinse containing 5% Hydroalcohol||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
|Official Title:||Four Weeks Clinical Efficacy of an Ethyl Lauroyl Arginate HCL (LAE) Mouth Rinse: Effect on Gingivitis|
- Whole Mouth Mean Bleeding Index (BI) at 4 weeks [ Time Frame: 4 weeks ]Bleeding will be assessed by using a standard measurement called the Gingival Bleeding Index.
- Whole Mouth Mean Bleeding Index (BI) at 1 week [ Time Frame: Within 2 weeks ]Bleeding will be assessed by using a standard measurement called the Gingival Bleeding Index
- Whole-mouth Mean Modified Gingival Index (MGI) [ Time Frame: Within 4 weeks ]Gingivitis will be assessed by scoring inflammation according to the Modified Gingival Index.
- Turesky Modification of the Quigley Hein Plaque Index (PI) [ Time Frame: Within 4 weeks ]Plaque will be assessed using a standard scale called the Turesky Modification of the Quigley Hein Plaque Index
- Extrinsic Stain [ Time Frame: Within 4 weeks ]Stain will be assessed using the standard measurement called Macpherson Modification of the Lobene Stain Index
|Study Start Date:||March 2014|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Neg Control Mouth Rinse W002194-0221-P
Mouth rinse containing 5% Hydroalcohol
Twice each day, brush in usual manner with a fluoride-containing dentifrice, rinse mouth with water, and then rinse with 20 ml of mouth rinse W002194-0221-P for 30 seconds and spit it out.
|Other: Mouth rinse containing 5% Hydroalcohol|
Experimental: Experimental: Mouth Rinse 19668-012
Listerine Advance Gum Defense Twice each day, brush in usual manner with a fluoride-containing dentifrice, 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.
|Other: Listerine Advance Gum Defense|
Active Comparator: Active Comparator Mouth Rinse 5000347078873
Mouth rinse containing Chlorhexidine Corsodyl ®Mouthwash
Twice each day, brush in usual manner with a fluoride-containing dentifrice, in the usual manner, rinse mouth with water, wait 5 minutes after brushing and then rinse with 10 ml of mouth rinse 5000347078873for 60 seconds and spit it out - do not swallow.
|Other: Mouth rinse containing Chlorhexidine|
At screening Participants will present to the clinical site having refrained from oral hygiene for at least 8 hours, but no more than 18 hours for baseline examinations (safety oral and hard soft tissue exam, MGI - Modified Gingival Index, BI - Bleeding Index and PI- Plaque Index and Extrinsic Staining. After the baseline oral examinations, qualifying participants will receive a whole-mouth supragingival dental prophylaxis and will be randomly assigned to one of three treatment groups.
Participants randomly assigned to the negative control treatment group will brush twice daily with a marketed fluoride toothpaste in their usual manner and rinse with a placebo mouth rinse. Participants randomly assigned to the experimental treatment group will brush twice daily with a marketed fluoride toothpaste brush in their usual manner and use an experimental mouth rinse. The last treatment group randomly assigned to the positive control will brush twice daily with a marketed fluoride toothpaste in their usual manner and rinse with a marketed available mouth rinse. Participants will have an equal chance of being assigned each of the three groups. The first product use will be conducted under supervision of study personnel. Participants will be required to stay at the site 20 minutes after the first use of product during visit 1 to monitor any potential analytic reaction. All other brushing and rinsing will be unsupervised and the participants will be required to maintain a diary card to document twice-daily product use, brushing and rinsing times. Diaries along with product accountability will be used to check for subject compliance.
Participants will return to the clinical site after 1 week (Day 7±1 day), 2 weeks (Day 14±2 days) and 4 weeks (Day 28±3 days). Oral hard and soft tissue safety, Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI) will be assessed by the primary examiner 1 at all visits Extrinsic stain will be assessed at baseline, 2 weeks and 4 weeks by the secondary examiner.
At the end of the study, subjects will return all used and unused product to the clinical site.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02065414
|National Research Ethics Committee Yorkshire & Humber-Sheffield|
|Chester, United Kingdom, M1 3DZ|
|Study Director:||Michael Lynch, DMD, PhD||Johnson & Johnson Consumer and Personal Products Worldwide|