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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

April 20, 2009
July 16, 2012
June 2009
June 2010   (final data collection date for primary outcome measure)
Difference in the Gingival Index scores between the start and the end of the study [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00885599 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gingivitis
  • Drug: Herbal API
    mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.
  • Drug: Cepacol
    mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.
  • 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.
  • 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.
  • Experimental: PERIORINSE
    naturopathic remedy
    Intervention: Drug: Herbal API
  • Active Comparator: CPC
    Cepacol, standard anti-bacterial mouthwash
    Intervention: Drug: Cepacol
  • Active Comparator: Listerine
    standard anti-bacterial mouthwash
    Intervention: Drug: Listerine Antiseptic Mouth Rinse
  • Placebo Comparator: placebo
    colored water
    Intervention: Drug: placebo mouthwash
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
14 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00885599
Gingival-ST2
No
Menachem Oberbaum, Shaare Zedek Medical Center
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Menachem Oberbaum, MD Shaare Zedek Medical Center
Shaare Zedek Medical Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP