Dutmanee Seriwatanachai, Terdphong Triratana, Luis R Mateo, Robert D'Ambrogio, Yun-Po Zhang
All 80 subjects completed the protocol. At baseline, there were no significant differences in organoleptic scores between groups (P= 0.816). After 3 weeks, the Test group showed a 37.8% reduction from baseline in overnight malodor scores (P< 0.001), while the Control group showed a 13.6% reduction (P< 0.001). The Test group demonstrated a statistically significant (P< 0.001) 28.0% greater reduction in oral malodor compared to the Control group. No adverse events were reported.
PURPOSE: To evaluate the clinical efficacy of a test toothpaste containing 0.454% stannous fluoride stabilized with zinc phosphate as compared to a control fluoride toothpaste containing 0.76% sodium monofluorophosphate on oral malodor reduction via organoleptic scores after 3 weeks of twice daily product use.
METHODS: A randomized, single-center, double-blind, parallel-group clinical trial conducted in Bangkok, Thailand. Eighty adult subjects with qualifying baseline oral malodor scores were randomized to use either the test toothpaste or the control toothpaste twice daily for 3 weeks. Efficacy was assessed using the organoleptic hedonic scale (1-9) by four calibrated judges. The primary endpoint was the reduction in organoleptic scores assessed 12 hours post-brushing (overnight).
RESULTS: All 80 subjects completed the protocol. At baseline, there were no significant differences in organoleptic scores between groups (P= 0.816). After 3 weeks, the Test group showed a 37.8% reduction from baseline in overnight malodor scores (P< 0.001), while the Control group showed a 13.6% reduction (P< 0.001). The Test group demonstrated a statistically significant (P< 0.001) 28.0% greater reduction in oral malodor compared to the Control group. No adverse events were reported.
CLINICAL SIGNIFICANCE: The 0.454% stannous fluoride toothpaste stabilized with zinc phosphate provided a superior, long-lasting solution for overnight oral malodor management compared to a standard sodium monofluorophosphate toothpaste after 3 weeks of use.