Clinical comparison of two tartar control dentifrices: a twelve-week study

The objective of this double-blind clinical study was to investigate the anticalculus efficacy of a new improved tartar control dentifrice formulation containing tetrasodium pyrophosphate, sodium tripolyphosphate, PVM/MA copolymer and 0.243% sodium fluoride in a silica base (New and Improved Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals) as the test dentifrice, compared to a previously marketed, American Dental Association-accepted, tartar control dentifrice formulation containing tetrasodium pyrophosphate, PVM/MA copolymer and 0.243% sodium fluoride in a silica base (Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals), as the positive control dentifrice. Adult male and female subjects were entered into the study based on a pre-test (baseline) Volpe-Manhold calculus index score of 7.0 or greater, provided a full oral prophylaxis, and stratified into two treatment groups which were balanced for age, sex and baseline calculus scores. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice using a soft-bristled toothbrush. Examinations for the formation of supragingival dental calculus were performed after twelve-weeks' use of the study dentifrices. Seventy-three (73) subjects complied with the protocol and completed the entire study. At the 12-week examination, the test dentifrice group exhibited a statistically significant (p < 0.0008) 44.1% reduction in the mean Volpe-Manhold calculus index score compared to the mean calculus scores of the previously marketed, positive control dentifrice group. Thus, the results of this clinical study support the conclusion that the New and Improved Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals is more efficacious in controlling the development of supragingival calculus formation than the previously marketed Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals.