Efficacy of a Naturally-derived Mouthrinse for Gingival Inflammation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Menachem Oberbaum, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00885599
First received: April 20, 2009
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Gingivitis
Drug: Herbal API
Drug: Cepacol
Drug: Listerine Antiseptic Mouth Rinse
Drug: placebo mouthwash
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Difference in the Gingival Index scores between the start and the end of the study [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The difference in C-Reactive protein levels between the start and the end of the study. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   14 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885599

Locations
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Menachem Oberbaum, MD Shaare Zedek Medical Center
  More Information

No publications provided

Responsible Party: Menachem Oberbaum, Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00885599     History of Changes
Other Study ID Numbers: Gingival-ST2
Study First Received: April 20, 2009
Last Updated: July 16, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Shaare Zedek Medical Center:
gingivitis
natural remedy
inflammation
C-reactive protein
mouthwash

Additional relevant MeSH terms:
Gingivitis
Inflammation
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Pathologic Processes
Anti-Infective Agents, Local
Listerine
Thymol
Cineole
Sodium Fluoride
Menthol
Salicylates
Methyl salicylate
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents
Antifungal Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 23, 2014