METHODS: This investigation consisted of a 12-week, observer-blind, single-center, randomized comparison of five parallel groups of subjects. 180 subjects granting their informed consent entered the trial and 171 completed. Subjects were randomized to 1 of 4 currently-marketed mouthrinses Crest ProHealth, Cepacol, Scope, Viadent or brushing alone with a currently-marketed fluoride toothpaste and stratified with respect to smoking status. Upon randomization, subjects received a baseline stain score and then a prophylaxis to remove all extrinsic stain. Clinical assessments were repeated after 6 weeks and 3 months of product use and subjects were asked to complete a questionnaire at baseline, day 4, day 14, 6 weeks and 12 weeks post baseline to assess potential taste alteration.
RESULTS: Crest ProHealth and Cepacol resulted in significantly more extrinsic stain (p<0.001) after six weeks of use versus brushing alone with fluoride toothpaste. Crest ProHealth, Cepacol (p<0.001) and Scope (p=0.01) resulted in significantly more stain versus brushing alone after 12 weeks. Viadent was not significantly different from brushing alone at either timepoint. Up to 53% of subjects using Crest ProHealth mouthrinse experienced taste interference for up to three hours post-rinse after using the product as directed for 6 weeks. CONCLUSIONS: The results of this study demonstrated that regular use of Crest ProHealth and Cepacol mouthrinses resulted in extrinsic stain accumulation after 6 weeks with increased accumulation after 12 weeks versus brushing alone.