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NCT Number: NCT00885599

Efficacy of a Naturally-derived Mouthrinse for 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.

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Key information

Age range

14 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Herbal API

Drug

mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.

Cepacol

Drug

mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.

Listerine Antiseptic Mouth Rinse

Drug

mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.

Placebo Mouthwash

Drug

colored water mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.

Primary outcomes

  1. Difference in the Gingival Index scores between the start and the end of the study

    Time frame: 14 days

Secondary outcomes

  1. The difference in C-Reactive protein levels between the start and the end of the study.

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 22, 2009
Registry last updated
Jul 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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