Efficacy of a Naturally-derived Mouthrinse for Gingival Inflammation

A Randomized Multi-treatment/Controlled Double-blinded Study to Evaluate the Efficacy of a Naturally-derived Mouthrinse in the Treatment of Gingival Inflammation.

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Herbal API; Drug: Cepacol; Drug: Listerine Antiseptic Mouth Rinse; Drug: placebo mouthwash

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 73 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PERIORINSE; naturopathic remedy	Drug: Herbal API; mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.
Active Comparator: CPC; Cepacol, standard anti-bacterial mouthwash	Drug: Cepacol; mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.
Active Comparator: Listerine; standard anti-bacterial mouthwash	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.
Placebo Comparator: placebo; colored water	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in the Gingival Index scores between the start and the end of the study	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The difference in C-Reactive protein levels between the start and the end of the study.	14 days

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Principal Investigator: Menachem Oberbaum, MD, Shaare Zedek Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: April 20, 2009
• First Submitted That Met QC Criteria: April 21, 2009
• First Posted (Estimate): April 22, 2009

Study Record Updates

• Last Update Posted (Estimate): July 17, 2012
• Last Update Submitted That Met QC Criteria: July 16, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: inflammation; C-reactive protein; gingivitis; mouthwash; natural remedy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Inflammation; Gingivitis; Anti-Infective Agents; Listerine; Anti-Infective Agents, Local
• Other Study ID Numbers: Gingival-ST2