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

NCT01821261 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-01-28

No results posted yet for this study

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.

Conditions

  • Gingivitis

Interventions

DEVICE

Mouth Rinse 19668-012

20 ml of experimental mouth rinse 19668-012 for 30 seconds, twice daily

DRUG

Mouth Rinse 500347078842

10 ml of mouth rinse 500347078842 for 60 seconds, twice daily

DRUG

Toothpaste 035000513007

Approximately one inch of toothpaste 035000513007, twice daily

Sponsors & Collaborators

  • Johnson & Johnson Consumer Inc. (J&JCI)

    lead INDUSTRY

Principal Investigators

  • Michael Lynch, DMD, PhD · Johnson & Johnson Consumer Inc. (J&JCI)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-04-30
Completion
2014-07-31
FDA Device
Yes

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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 NCT01821261 on ClinicalTrials.gov