Clinical efficacy of a stannous fluoride toothpaste stabilized with zinc phosphate in reducing supragingival calculus formation compared to a sodium monofluorophosphate toothpaste: A randomized controlled trial.

Abstract

Purpose: To evaluate the comparative clinical efficacy of a test toothpaste containing 0.454% stannous fluoride stabilized with zinc phosphate as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate in controlling supragingival calculus formation over a 12-week period.

Methods: A randomized, single-center, double-blind, parallel-group study was conducted in Bangkok, Thailand. Healthy adults (n= 100) with a baseline Volpe-Manhold Calculus Index score ≥7.0 were randomized to either the stannous fluoride (Test) or sodium monofluorophosphate (Control) group. After a dental prophylaxis, subjects brushed twice daily for 12 weeks. Supragingival calculus was assessed using the Volpe-Manhold Calculus Index. The primary efficacy endpoint was the comparison of baseline-adjusted mean calculus scores at 12 weeks, analyzed using ANCOVA.

Results: 97 subjects completed the study. At 12 weeks, the Test Group had baseline adjusted mean Volpe-Manhold score of 11.47, while the Control Group had a score of 17.48. The Test Group demonstrated a statistically significant 34.4% (P< 0.001) less supragingival calculus formation compared to the Control Group.

Clinical significance: A toothpaste containing 0.454% stannous fluoride provided a statistically significant and clinically relevant reduction in supragingival calculus formation compared to a standard sodium monofluorophosphate fluoride toothpaste after 12 weeks of use.