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Efficacy of a Naturally-derived Mouthrinse for Gingival Inflammation

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.
 
ClinicalTrials.gov Identifier: NCT00885599
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : July 17, 2012
Sponsor:
Information provided by (Responsible Party):
Menachem Oberbaum, Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE April 20, 2009
First Posted Date  ICMJE April 22, 2009
Last Update Posted Date July 17, 2012
Study Start Date  ICMJE June 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2009)
Difference in the Gingival Index scores between the start and the end of the study [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2009)
The difference in C-Reactive protein levels between the start and the end of the study. [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of a Naturally-derived Mouthrinse for Gingival Inflammation
Official Title  ICMJE A Randomized Multi-treatment/Controlled Double-blinded Study to Evaluate the Efficacy of a Naturally-derived Mouthrinse in the Treatment of Gingival Inflammation.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gingivitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2010)
94
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2009)
100
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00885599
Other Study ID Numbers  ICMJE Gingival-ST2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Menachem Oberbaum, Shaare Zedek Medical Center
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Menachem Oberbaum, MD Shaare Zedek Medical Center
PRS Account Shaare Zedek Medical Center
Verification Date July 2012

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