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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

Page last updated: August 23, 2015

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