Clinical trial NCT01821261: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Gingivitis
Keywords: Gums
Gingiva
Gingival Inflammation
Gingival Bleeding
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2013-03-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Whole-mouth Mean Bleeding Index (BI) at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Whole-mouth Mean Bleeding Index (BI)
timeFrame: within 4 weeks
measure: Whole-mouth Mean Modified Gingival Index (MGI)
timeFrame: within 3 months
measure: Whole Mouth Mean Plaque Index (PI)
timeFrame: within 3 months
measure: Mean Area Stain Score for Mesial Region
timeFrame: within 3 months
measure: Mean Area Stain Score for Gingival Region
timeFrame: within 3 months
measure: Mean Area Stain Score for Distal Region
timeFrame: within 3 months
measure: Mean Area Stain Score for Body of Tooth
timeFrame: within 3 months
measure: Mean Stain Intensity Score
timeFrame: within 3 months
measure: Mean Tartar Height
timeFrame: within 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Consumer Inc. (J&JCI)
name: Michael Lynch, DMD, PhD
role: STUDY_DIRECTOR
References: