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

• Status: Withdrawn
• Trial end date: 2014-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Treatments: Chlorhexidine; Fluorides

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