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Withdrawn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:
Participant gender:
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.