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Executive Summary

P&G STUDYING .12% CHLORHEXIDINE MOUTHRINSE FOR GINGIVITIS, Procter & Gamble researchers reported at the American Assn. of Dental Researchers recent annual meeting in Washington, D.C. Investigators O. P. Sturzenberger, et al, reported the results of a six-month clinical study in which an unspecified number of patients were given prophylactic treatment and then put on a program of oral mouthrinses, receiving either a .12% chlorhexidine solution or a placebo. "The average reduction in gingivitis severity obverved in this study was 45%," an abstract of the study reports. Sturzenberger, et al, stated that a previous study had shown that "a prophylaxis [treatment] significantly reduced gingivitis severity by 45%" but that the clinical benefit "diminished over a 10-day period following the prophylaxis, at which time gingivitis severity returned to baseline levels." The researchers reported that use of chlorhexidine rinse maintained the reduced gingivitis levels for the entire six months of the study. The investigators also noted that "when the clinical population was subdivided into groups according to their initial gingivitis severity (i.e., number of gingival bleeding sites), those subjects with the most gingival bleeding showed a 61% reduction in gingivitis severity compared to baseline." P&G has reportedly been studying chlorhexidine for over a decade. The ingredient is currently marketed in European oral health care products at concentrations of .2%. FDA's OTC Dentifrice and Dental Care Products panel did not consider chlorhexidine in its report. P&G researchers D.J. Moore, et al., also conducted a six-month study on 430 individuals in an attempt to determine possible side effects of chlorhexidine. Previous studies and experience in Europe showed that continued use of the ingredient could cause staining and a rise in calculus (tartar) accumulation. The study's conclusions did reveal a statistically higher accumulation of tartar, but no concurrent decrease in the effectiveness of chlorhexidine as an antimicrobial and antigingival. Furthermore, only 15% of the 430 participants developed heavy stains while 44% had no visual increase in stains, an abstract of the study said, adding that the stains that did occur were readily removable.

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