Clinical evaluation of the stain removal efficacy of a novel stannous fluoride and sodium hexametaphosphate dentifrice.

PURPOSE Recently, sodium hexametaphosphate has been introduced in dentifrice formulations to aid in the control of extrinsic stain. Two independent studies were conducted to evaluate the stain removal efficacy of a novel 0.454% stannous fluoride and sodium hexametaphosphate dentifrice (Crest Pro-Health) relative to a positive control whitening dentifrice (Colgate Total + Whitening) over a 2-week period in a subject population with pre-existing natural extrinsic stain. METHODS These studies were randomized, positive-controlled, parallel groups, double-blind, 2-week trials. Each study involved approximately 30 healthy adults with visible stain of the facial surfaces of the 12 anterior teeth. After baseline examination, subjects were randomly assigned to a treatment and instructed to brush unsupervised with the assigned dentifrice at least twice daily as they normally do. Efficacy was evaluated by modified Lobene examination on anterior teeth at baseline and end-of treatment (Week 2). RESULTS 59 subjects, 29 in Study 1 and 30 in Study 2, were evaluable and included in the Week 2 analyses. Subjects ranged from 21-68 years of age. In each study, the positive control dentifrice statistically significantly (P < 0.0001) reduced stain scores following 2 weeks of brushing with median reductions of 61.9% and 94.4%. Similarly, the experimental 0.454% stannous fluoride and sodium hexametaphosphate dentifrice statistically significantly (P < 0.0001) reduced stain scores by 61.8% and 96.6% following 2 weeks of brushing. The adjusted mean changes between treatment groups did not differ significantly between the two dentifrice groups (P > 0.70 in each study). Both dentifrices were well tolerated. No subject discontinued treatment due to an adverse event.