Efficacy of a Naturally-derived Mouthrinse for Gingival Inflammation
Condition: Gingivitis
MeSH terms: Gingivitis; Inflammation
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    


Intervention name(s): Herbal API; Cepacol; Listerine Antiseptic Mouth Rinse; placebo mouthwash
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.; mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.; mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.; colored water mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.
Intervention MeSH terms: Listerine; Anti-Infective Agents, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingivitis; natural remedy; inflammation; C-reactive protein; mouthwash