The objective of this double-blind clinical study, conducted using the Volpe-Manhold design for studies of
dental calculus, was to confirm the supragingival anticalculus efficacy of a formulation variant of a commercially available anticalculus
dentifrice. The commercially available
dentifrice (
Colgate Total Toothpaste) contains 0.3%
triclosan and 2.0%
PVM/MA copolymer in a 0.243%
sodium fluoride/
silica base. The new formulation variant contains those same ingredients, of which 10% of the
silica is a high cleaning grade (
Colgate Total Plus Whitening Toothpaste). In this study, the
dentifrice formulation variant was tested for anticalculus efficacy against a negative control
dentifrice containing 0.243%
sodium fluoride/
silica. Adult male and female subjects from the northern New Jersey area 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
dental calculus were again performed after eight weeks' use of the study
dentifrices. Sixty-three (63) subjects complied with the protocol and completed the entire study. At the eight-week examination, subjects in the
Colgate Total Plus Whitening Toothpaste group exhibited a statistically significant 34.13% reduction in mean Volpe-Manhold
Calculus Index score as compared to the negative control
dentifrice group. Thus, the results of this clinical study support the conclusion that a new
dentifrice formulation variant containing a special grade of
silica (
Colgate Total Plus Whitening Toothpaste) is efficacious for the control of the formation of supragingival
calculus.