The objective of this double-blind clinical study, conducted in harmony with the Volpe-Manhold design for studies of
dental calculus, was to compare the effect on supragingival
calculus formation of a
dentifrice containing
pyrophosphate,
tripolyphosphate and a copolymer in a 0.243%
sodium fluoride/
silica base (Test
Dentifrice), to that of a commercially available
calculus-inhibiting
dentifrice containing
tetrapotassium pyrophosphate,
disodium pyrophosphate, and
tetrasodium pyrophosphate in a 0.243%
sodium fluoride/
silica base (Positive Control
Dentifrice). Adult male and female subjects from the Northern New Jersey area were entered into the study, provided a full oral prophylaxis and assigned the use of a placebo (non-
calculus-inhibiting)
dentifrice for eight weeks. At the completion of this initial period, subjects were assessed for baseline Volpe-Manhold
Calculus Index scores, provided another full prophylaxis and stratified into two treatment groups which were balanced for age, sex and baseline
calculus. 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 twelve weeks' use of the study
dentifrices. Eighty-nine (89) subjects complied with the protocol and completed the entire study. At the three-month examination, the Test
Dentifrice group exhibited a statistically significant 31.0% reduction in the mean Volpe-Manhold
Calculus Index score compared to the Positive Control
Dentifrice group. The results of this clinical study support the conclusion that a new
calculus-inhibiting
dentifrice containing
pyrophosphate,
tripolyphosphate, and a copolymer in a 0.243%
sodium fluoride/
silica base is efficacious for the control of the development of supragingival
calculus, and provides a level of benefit greater than that provided by a commercially available
calculus-inhibiting
dentifrice containing
tetrapotassium pyrophosphate,
disodium pyrophosphate, and
tetrasodium pyrophosphate in a 0.243%
sodium fluoride/
silica base.