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.