Comparative clinical trial of two antigingivitis mouthrinses.
OBJECTIVE
To compare the safety and the antiplaque and antigingivitis efficacy of two oral rinses.


METHODS
A randomized, double-blind, parallel groups, single-center study was conducted to evaluate the safety and efficacy of a high bioavailable, alcohol-free 0.07% cetylpyridinium chloride (CPC) rinse (Crest Pro-Health Rinse) and a positive control rinse containing essential oils (EO) and 21.6% ethyl alcohol (Cool Mint Listerine). Seventy-eight healthy adults were enrolled in a modified experimental gingivitis clinical trial. Four weeks before the baseline visit, subjects received a prophylaxis and were instructed to brush twice daily in a manner to approach optimum gingival health. At the end of the 4-week period, subjects were randomly assigned to treatment and instructed to use 20 ml of their assigned product for 30 seconds after brushing twice daily during a 21-day treatment phase. Plaque removal by brushing was prevented during the treatment phase for one mandibular quadrant (experimental gingivitis region) by means of a specially-manufactured tooth shield. Safety and efficacy measurements were obtained at baseline and at the end-of-treatment using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and Modified Quigley-Hein Plaque Index (MQH). At all visits, an oral soft tissue examination was performed for each subject. The efficacy data obtained in the experimental gingivitis region were analyzed with analysis of covariance.


RESULTS
Seventy-five subjects completed the study and were included in the data analyses. No statistically significant differences were detected between the two treatment groups for MGI, GBI or MQH measures. Results were similar for shielded interproximal sites. Both treatments were well-tolerated.


CONCLUSIONS
This randomized, controlled comparative clinical trial demonstrated that rinsing twice daily with the experimental alcohol-free 0.07% CPC rinse provides antiplaque and antigingivitis efficacy similar to that of the positive control EO rinse, a recognized antiplaque and antigingivitis mouthrinse that contains alcohol.
Witt
Jon J
JJ
The Procter and Gamble Company, Health Care Research Center, Mason, Ohio 45040-9462, USA. witt.jj.2@pg.com
Walters
Patricia
P
Bsoul
Samer
S
Gibb
Roger
R
Dunavent
John
J
Putt
Mark
M
D000328:Adult; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D002594:Cetylpyridinium / Q000627:therapeutic use*; D003773:Dental Plaque / Q000517:prevention & control; D003774:Dental Plaque Index; D004311:Double-Blind Method; D004338:Drug Combinations; D005884:Gingival Hemorrhage / Q000517:prevention & control; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D009061:Mouth Mucosa / Q000187:drug effects; D009067:Mouthwashes / Q000627:therapeutic use*; D010512:Periodontal Index; D012449:Safety; D012459:Salicylates / Q000627:therapeutic use; D013729:Terpenes / Q000627:therapeutic use
D000891:Anti-Infective Agents, Local; C505193:Crest Pro-Health mouthrinse; D004338:Drug Combinations; D009067:Mouthwashes; D012459:Salicylates; D013729:Terpenes; C057473:Listerine; D002594:Cetylpyridinium