Efficacy of a Naturally-derived Mouthrinse for Gingival Inflammation
Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
Summary
Gingivitis, defined as inflammation of the gingival tissues, has long been associated with
bacterial accumulation [plaque] on the tooth surface adjacent to the gingiva, causing an
inflammatory reaction. Experimental gingivitis in health adults can be induced by abstension
from brushing teeth for 9 to 21 days, and can test the effects of numerous chemotherapeutic
agents, rinses and toothpastes. Effective prevention of plaque accumulation can prevent
destructive forms of periodontal disease.
A recent link has been established between localized gingival inflammation and systemic
inflammation and a number of disease processes. Periodontal disease may lead to elevated
C-reactive protein [CRP], considered a potential risk factor for cardiovascular disease and
stroke. It has been shown that reducing gingival inflammation is accompanied with a
significant decrease in serum CRP levels.
Naturopathic remedies for treating oral disease have been well documented in the medical and
dental literature since early civilization, and have become more and more popular in recent
years. We propose to study one such remedy, PERIORINSE. This remedy consists of a number of
herbs, and has been shown to exhibit antibacterial and anti-inflammatory effects.
Specifically, it has been shown to block the proteolytic effects seen in gingival
inflammation . This study will evaluate the efficacy of this formulation, using currently
accepted clinical testing protocols.
A Random sample of 100 healthy volunteers who fulfill all inclusion criteria and no exclusion
criteria, will be included in the study. Patients will randomly selected to one of 4
treatment groups: PERIORINSE (n=25), CPC (Cepacol) mouthwash (25 patients), Listerine
mouthwash (n=25), and placebo (colored water) mouthrinse. Patients will be examined at
baseline, and Gingival Index taken for all teeth. A blood specimen will be taken to measure
CRP levels as well. Patients will be given a full dental prophylaxis which includes scaling
and tooth polishing, and given rinsing instructions and reminded to cease all other oral
hygiene methods including brushing, flossing, and rinsing with any other rinse for a period
of 14 days. On day 14, patients will be re-examined and Gingival Index taken for all teeth.
Patients will be given a full dental prophylaxis which includes scaling and tooth polishing
and required to reinstitute their original oral hygiene regimen. CRP levels will be measured
again, as well.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Shaare Zedek Medical Center
Treatments:
Anti-Infective Agents, Local Listerine Sodium Fluoride