Efficacy of a dentifrice containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity: a twelve-week clinical study.

The effect on dentinal hypersensitivity from the use of a dentifrice containing 5.0% potassium nitrate, 1.3% soluble pyrophosphate, 1.5% PVM/MA copolymer, and 0.243% sodium fluoride in a silica base over a twelve-week period was compared to a matching placebo dentifrice without potassium nitrate. A total of sixty-seven subjects were entered into the study, and stratified into two balanced groups according to their baseline mean thermal (threshold) temperature (Thermodontic Stimulator) and baseline mean tactile (Yeaple Probe) sensitivity scores. The two groups were randomly assigned to use either the potassium nitrate/copolymer/pyrophosphate dentifrice or the placebo dentifrice. The two groups were well balanced with regard to their mean baseline thermal and tactile sensitivity scores, sex and age. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Dentinal hypersensitivity examinations, which included tactile sensitivity, threshold thermal sensitivity, pain thermal sensitivity, air blast, and a visual analog scale were conducted at baseline, six weeks, and twelve weeks. All examinations were conducted by the same dental examiner. After six weeks' use of their assigned products, those subjects in the potassium nitrate/copolymer/pyrophosphate dentifrice group demonstrated statistically significant improvements (p < 0.01), as compared to the placebo dentifrice, in the following parameters: 1) tactile; 2) thermal (threshold and pain); and 3) air blast. After twelve weeks' use of their assigned products, those subjects in the potassium nitrate/copolymer/pyrophosphate dentifrice group again demonstrated statistically significant improvements (p < 0.01), in tactile, thermal (threshold and pain) and air blast sensitivity, as compared to the placebo dentifrice. It was concluded from this study that a dentifrice containing 5.0% potassium nitrate, 1.3% soluble pyrophosphate, 1.5% PVM/MA copolymer, and 0.243% sodium fluoride in a silica base is a clinically effective treatment for reducing dentinal hypersensitivity.