The objective of this double-blind clinical study was to investigate the an
ti calculus efficacy of a new improved tartar control dentifrice formulatio
n containing tetrasodium pyrophosphate, sodium tripolyphosphate, PVM/MA cop
olymer and 0.243% sodium fluoride in a silica base (New and Improved Colgat
e(R) Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals) as th
e test dentifrice, compared to a previously marketed, American Dental Assoc
iation-accepted, tartar control dentifrice formulation containing tetrasodi
um pyrophosphate, PVM/MA copolymer and 0.243% sodium fluoride in a silica b
ase (Colgate(R) Tartar Control Fluoride Toothpaste with Micro-Cleaning Crys
tals), as the positive control dentifrice. Adult male and female subjects w
ere entered into the study based on a pre-rest (baseline) Volpe-Manhold cal
culus 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 b
aseline calculus scores. Subjects were instructed to brush their teeth twic
e daily (morning and evening) for one minute with their assigned dentifrice
using a soft-bristled toothbrush. Examinations for the formation of suprag
ingival dental calculus were performed after twelve-weeks' use of the study
dentifrices. Seventy-three (73) subjects complied with the protocol and co
mpleted the entire study. Ar the 12-week examination, the test dentifrice g
roup exhibited a statistically significant (p < 0.0008) 44.1% reduction in
the mean Volpeh-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 Cr
ystals is more efficacious in controlling the development of supragingival
calculus formation than the previously marketed Colgate Tartar Control Fluo
ride Toothpaste with Micro-Cleaning Crystals.