Objective: A multi-site, two arm, parallel group study was conducted to assess the relative efficacy of a Sodium Tripolyphosphate(STP)/polyvinylpyrrollidone(PVP)toothpaste in the prevention of the accumulation of calculus as compared to a marketed toothpaste, Crest® Regular. Methods:After an examination to identify subjects with calculus, an oral prophylaxis was administered, and subjects began a run-in period of 6 weeks to confirm calculus buildup. Subjects who presented at Baseline after the 6-week run-in period and met all entrance criteria were randomized into the study. An oral prophylaxis was conducted to render subjects' teeth calculus-free prior to commencing the 12-week treatment period. 217 subjects were assigned to one of two treatment groups 1)Experimental Toothpaste, containing STP/PVP(N=105) or 2) Crest® Regular toothpaste (N=112). All subjects brushed their teeth twice daily with their assigned toothpaste and the Aquafresh® Flex toothbrush provided. After the Baseline visit subjects attended 4, 8, and 12-week evaluation visits. Oral soft tissue examinations were conducted at all visits. Assessments of calculus using the Volpe Manhold Index (VMI) were made at Baseline (prior to oral prophylaxis) and after 8 and 12 weeks of treatment. Results: Both toothpastes were well tolerated. Analyses were performed using the Cochran-Mantel-Haenzel Test adjusted for baseline, gender and site. There was a statistically significant difference in the mean VMI calculus score between subjects brushing with the Experimental Toothpaste and subjects brushing with Crest® at both Week 8 and Week 12 in favor of the Experimental Toothpaste Group (p<0.001). Subjects in the Experimental Toothpaste Group had a higher percentage of calculus-free sites than subjects in Crest® Regular Toothpaste Group at both Week 8 and Week 12 (p<0.001). Conclusions: The results of this study indicate that an STP/PVP toothpaste used twice daily is efficacious for the control of supragingival calculus.

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