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

NCT02065414 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2014-09-05

No results posted yet for this study

Summary

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.

Conditions

  • Gingivitis

Interventions

OTHER

Listerine Advance Gum Defense

OTHER

Mouth rinse containing Chlorhexidine

OTHER

Mouth rinse containing 5% Hydroalcohol

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Michael Lynch, DMD, PhD · Johnson & Johnson Consumer and Personal Products Worldwide

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02065414 on ClinicalTrials.gov