OBJECTIVES: The objectives of this clinical trial were to determine the tooth staining potential as measured by the Macpherson Modification of the Lobene Stain Index, and degree of taste alteration of four currently marketed mouthrinses when used over a 12-week period. METHODS: This investigation consisted of a 12-week, observer-blind, single-center, randomized comparison of five parallel groups of subjects. One-hundred and seventy-one subjects granting their informed consent completed the trial. Subjects were randomized to one of four currently marketed mouthrinses Crest PRO-HEALTH Rinse (CPH), Cēpacol (C), Scope (S), Viadent ADVANCED CARE (V), or brushing alone (BA) with a currently marketed fluoride toothpaste. Upon randomization, subjects received a baseline stain score and then a prophylaxis to remove all extrinsic stain. Clinical assessments were repeated after six weeks and three months of product use, and subjects were asked to complete a questionnaire after the first use, at day 4, day 14, at six weeks, and 12 weeks to assess potential taste alteration. RESULTS: CPH and C demonstrated significantly (p < 0.001) more extrinsic stain after six weeks of use, and CPH, C (p < 0.001), and S (p = 0.01) after 12 weeks of use versus brushing alone with fluoride toothpaste. V was not significantly different from brushing alone at either time point. After six weeks of using the product as directed, up to 53% of subjects using CPH experienced taste interference for up to three hours post-rinse. CONCLUSIONS: The results of this study demonstrated that regular use of CPH and C mouthrinses resulted in extrinsic stain accumulation after six weeks, with increased accumulation after 12 weeks versus brushing alone.
RCT Entities:
OBJECTIVES: The objectives of this clinical trial were to determine the tooth staining potential as measured by the Macpherson Modification of the Lobene Stain Index, and degree of taste alteration of four currently marketed mouthrinses when used over a 12-week period. METHODS: This investigation consisted of a 12-week, observer-blind, single-center, randomized comparison of five parallel groups of subjects. One-hundred and seventy-one subjects granting their informed consent completed the trial. Subjects were randomized to one of four currently marketed mouthrinses Crest PRO-HEALTH Rinse (CPH), Cēpacol (C), Scope (S), Viadent ADVANCED CARE (V), or brushing alone (BA) with a currently marketed fluoride toothpaste. Upon randomization, subjects received a baseline stain score and then a prophylaxis to remove all extrinsic stain. Clinical assessments were repeated after six weeks and three months of product use, and subjects were asked to complete a questionnaire after the first use, at day 4, day 14, at six weeks, and 12 weeks to assess potential taste alteration. RESULTS:CPH and C demonstrated significantly (p < 0.001) more extrinsic stain after six weeks of use, and CPH, C (p < 0.001), and S (p = 0.01) after 12 weeks of use versus brushing alone with fluoride toothpaste. V was not significantly different from brushing alone at either time point. After six weeks of using the product as directed, up to 53% of subjects using CPH experienced taste interference for up to three hours post-rinse. CONCLUSIONS: The results of this study demonstrated that regular use of CPH and C mouthrinses resulted in extrinsic stain accumulation after six weeks, with increased accumulation after 12 weeks versus brushing alone.