Clinical effectiveness of a triclosan/copolymer/sodium-fluoride dentifrice in controlling oral malodor: a three-week clinical trial.

The purpose of this study was to compare the effectiveness of a commercially available, clinically proven, American Dental Association (ADA)-Accepted dentifrice containing 0.30% triclosan, 2% polyvinylmethylether/maleic acid (PVM/MA) copolymer, and 0.243% sodium fluoride in a 10% high-cleaning silica base (Colgate Total Advanced Fresh) to a commercially available, clinically proven, ADA-Accepted control dentifrice containing 0.243% sodium fluoride in a silica base (Colgate Cavity Protection Winterfresh Gel) for the management of oral malodor in a 3-week, randomized, double-blind longitudinal clinical trial. A panel of four expert judges used a nine-point hedonic scale to evaluate breath odor using a protocol designed in concordance with the ADA Draft Acceptance Program Guidelines for Products Used in the Management of Oral Malodor. After a baseline evaluation, prospective study subjects who scored above the threshold value for unpleasant breath odor were stratified by score and randomized into two treatment groups. Subjects were provided with a soft-bristled toothbrush and brushed their teeth thoroughly in their regular and customary manner for 1 minute with their assigned dentifrice, twice daily. Before oral-malodor evaluations, the subjects refrained from eating odorigenic foods and did not use dental hygiene procedures, breath mints, or mouth rinses. Eighty-one adult men and women from Chengdu, China, completed the study. Throughout the study, the mean breath-odor scores observed in the Colgate Total Advanced Fresh toothpaste group for both daytime and overnight were within the range of values associated with pleasant breath odor, were statistically significantly lower than the corresponding mean scores for the control group, and also represented statistically significant reductions from baseline. Relative to the baseline score, more than 80% of the subjects in the Colgate Total Advanced Fresh toothpaste group demonstrated a 3.2 or more unit reduction in organoleptic scores at every postbaseline breath-odor evaluation. Thus, the overall results of the double-blind clinical study support the conclusions that Colgate Total Advanced Fresh toothpaste is efficacious for the control of oral malodor for up to 12 hours in the daytime and up to 12 hours overnight.