PURPOSE: This single-center, double-blind, randomized, parallel-group clinical study was designed to investigate the extrinsic stain removal efficacy of a new antisensitivity dentifrice containing 0.3% triclosan, 2% polyvinylmethyl ether/maleic acid copolymer (PVM/MA copolymer), 0.243% NaF and a new silica specially-designed to occlude dentin tubules, relative to a Positive Control dentifrice and a Negative Control dentifrice. METHODS:117 qualifying adults were stratified by baseline Lobene Stain Index scores and randomly assigned to brush twice daily using a soft-bristled toothbrush and one of three dentifrices: (1) the Test Dentifrice; (2) a previously clinically proven dentifrice variant containing 0.3% triclosan, 2% PVM/MA copolymer, 0.243% NaF in a high cleaning silica base (Positive Control); and (3) a dentifrice containing 0.243% NaF in a silica base (Negative Control). Extrinsic stain area and stain intensity examinations were repeated after 3 and 6 weeks of product use. RESULTS: Relative to the Negative Control group, the Test group and the Positive Control group exhibited statistically significant improvements in mean Lobene composite stain scores after 3 weeks of product use (39.8% and 40.7% respectively) and after 6 weeks of product use (58.8% and 61.8% respectively). There were no statistically significant differences observed between the stain removal performance of the Test Dentifrice and the Positive Control Dentifrice after 3 and 6 weeks of product use.
RCT Entities:
PURPOSE: This single-center, double-blind, randomized, parallel-group clinical study was designed to investigate the extrinsic stain removal efficacy of a new antisensitivity dentifrice containing 0.3% triclosan, 2% polyvinylmethyl ether/maleic acid copolymer (PVM/MA copolymer), 0.243% NaF and a new silica specially-designed to occlude dentin tubules, relative to a Positive Control dentifrice and a Negative Control dentifrice. METHODS: 117 qualifying adults were stratified by baseline Lobene Stain Index scores and randomly assigned to brush twice daily using a soft-bristled toothbrush and one of three dentifrices: (1) the Test Dentifrice; (2) a previously clinically proven dentifrice variant containing 0.3% triclosan, 2% PVM/MA copolymer, 0.243% NaF in a high cleaning silica base (Positive Control); and (3) a dentifrice containing 0.243% NaF in a silica base (Negative Control). Extrinsic stain area and stain intensity examinations were repeated after 3 and 6 weeks of product use. RESULTS: Relative to the Negative Control group, the Test group and the Positive Control group exhibited statistically significant improvements in mean Lobene composite stain scores after 3 weeks of product use (39.8% and 40.7% respectively) and after 6 weeks of product use (58.8% and 61.8% respectively). There were no statistically significant differences observed between the stain removal performance of the Test Dentifrice and the Positive Control Dentifrice after 3 and 6 weeks of product use.