Efficacy of a Naturally-derived Mouthrinse for Gingival Inflammation
Information source: Shaare Zedek Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gingivitis
Intervention: Herbal API (Drug); Cepacol (Drug); Listerine Antiseptic Mouth Rinse (Drug); placebo mouthwash (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Shaare Zedek Medical Center Official(s) and/or principal investigator(s): Menachem Oberbaum, MD, Principal Investigator, Affiliation: Shaare Zedek Medical Center
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.
Clinical Details
Official title: A Randomized Multi-treatment/Controlled Double-blinded Study to Evaluate the Efficacy of a Naturally-derived Mouthrinse in the Treatment of Gingival Inflammation.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Difference in the Gingival Index scores between the start and the end of the study
Secondary outcome: The difference in C-Reactive protein levels between the start and the end of the study.
Eligibility
Minimum age: 14 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 14-75.
- Clinical diagnosis of Gingivitis as measured by the Gingival index ≤ 0. 5
- Healthy volunteer willing to cease all oral hygiene methods except for the mouthrinse
for a period of three weeks.
- Have at least 24 teeth in their mouth
Exclusion Criteria:
- Pregnant or planning to become pregnant during the study period.
- Periodontal pockets greater than 5mm in 3 or more areas.
- History of periodontal treatment within the last month.
- Antibiotic treatment within the last month
- Use of any antimicrobial mouthrinse within the last month.
- Participation in another trial within one month prior to the study.
- Inability to comply with the trial protocol by not rinsing with mouthrinse 20% of
time.
- Inability to comply, brushing the teeth or using another mouthrinse during the study
period.
- Systemic Disease.
- On antibiotic or anti-inflammatory medication
- Cigarette-smoking
Locations and Contacts
Shaare Zedek Medical Center, Jerusalem 91031, Israel
Additional Information
Starting date: June 2009
Last updated: July 16, 2012
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