Clinical Efficacy of Two Dentifrices on Controlling Calculus Formation

Objectives: The aim of this double-blind clinical study was to assess the calculus formation control efficacy for two products (1) a toothpaste that contains 0.454% stannous fluoride stabilized with zinc phosphate (Test) and (2) a toothpaste containing 0.76% sodium monofluorophosphate (Negative Control).
Methods: Following baseline examinations of Volpe-Manhold Calculus Index and soft tissue, qualified subjects presenting an initial (V-MCI) score ≥7, entered an 8-week pre-test phase. After receiving an oral evaluation and a prophylaxis, subjects were instructed to brush twice daily (morning and evening) for 1 minute each time. After eight weeks, subjects received a baseline supragingival calculus examination via V-MCI. Subjects were randomized into two groups (Test and Negative Control), which were balanced for Volpe-Manhold Calculus Index. All subjects received a prophylaxis, were provided with their assigned toothpaste, and were instructed to brush as described previously. Examinations of Volpe-Manhold Calculus Index scores were conducted again after twelve weeks of product use.
Results: After the clinical protocol was approved by an IRB, one-hundred (100) subjects entered the clinical study, and 97 out of 100 complied with the protocol and completed the twenty-week study. At the 12-week examination, the Test Group-subjects presented a mean Volpe-Manhold Calculus Index score=11.47 and the Control Group=17.48. Subjects in the Test Group exhibited statistically significant less supragingival calculus formation compared to subjects in the Control Group at 12-weeks (34.4%).
Conclusions: The clinical study supported that the toothpaste containing 0.454% stannous fluoride stabilized with zinc phosphate provided statistically significant greater control of supragingival calculus formation relative to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate.