Efficacy of a Naturally-derived Mouthrinse for Gingival Inflammation

NCT00885599 | Completed Phase 1

• 1 other identifier: Gingival-ST2
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis

Keywords

gingivitis; natural remedy; inflammation; C-reactive protein; mouthwash

Outcome Measures

Primary Outcomes (1)

• Difference in the Gingival Index scores between the start and the end of the study

  14 days

Secondary Outcomes (1)

• The difference in C-Reactive protein levels between the start and the end of the study.

  14 days

Study Arms (4)

PERIORINSE

EXPERIMENTAL

naturopathic remedy

Drug: Herbal API

CPC

ACTIVE COMPARATOR

Cepacol, standard anti-bacterial mouthwash

Drug: Cepacol

Listerine

ACTIVE COMPARATOR

standard anti-bacterial mouthwash

Drug: Listerine Antiseptic Mouth Rinse

placebo

PLACEBO COMPARATOR

colored water

Drug: placebo mouthwash

Interventions

Herbal API DRUG

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

PERIORINSE

Cepacol DRUG

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

CPC

Listerine Antiseptic Mouth Rinse DRUG

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

Listerine

placebo mouthwash DRUG

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

placebo

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Gingivitis; Inflammation

Interventions

Benzocaine

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Menachem Oberbaum, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Integrative Complementary Medicine

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 22, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

IL (1)