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Efficacy of a Naturally-derived Mouthrinse for Gingival Inflammation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00885599
First Posted: April 22, 2009
Last Update Posted: July 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Menachem Oberbaum, Shaare Zedek Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.

Further study details as provided by Menachem Oberbaum, 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 ]

Secondary Outcome Measures:
  • The difference in C-Reactive protein levels between the start and the end of the study. [ Time Frame: 14 days ]

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

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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 20, 2009
First Posted: April 22, 2009
Last Update Posted: July 17, 2012
Last Verified: July 2012

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

Additional relevant MeSH terms:
Inflammation
Gingivitis
Pathologic Processes
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents, Local
Listerine
Sodium Fluoride
Anti-Infective Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs