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Efficacy of a Naturally-derived Mouthrinse for Gingival Inflammation

NCT ID: NCT00885599

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gingivitis

Keywords

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gingivitis natural remedy inflammation C-reactive protein mouthwash

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PERIORINSE

naturopathic remedy

Group Type EXPERIMENTAL

Herbal API

Intervention Type DRUG

mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.

CPC

Cepacol, standard anti-bacterial mouthwash

Group Type ACTIVE_COMPARATOR

Cepacol

Intervention Type DRUG

mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.

Listerine

standard anti-bacterial mouthwash

Group Type ACTIVE_COMPARATOR

Listerine Antiseptic Mouth Rinse

Intervention Type DRUG

mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.

placebo

colored water

Group Type PLACEBO_COMPARATOR

placebo mouthwash

Intervention Type DRUG

colored water mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.

Interventions

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Herbal API

mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.

Intervention Type DRUG

Cepacol

mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.

Intervention Type DRUG

Listerine Antiseptic Mouth Rinse

mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.

Intervention Type DRUG

placebo mouthwash

colored water mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Menachem Oberbaum

Director, Center for Integrative Complementary Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Menachem Oberbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

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Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Gingival-ST2

Identifier Type: -

Identifier Source: org_study_id