Method:
A randomized, examiner blind, crossover-design study was conducted in a population of healthy adults aged 18-65 years. At V1, informed consent was obtained and an initial eligibility assessment was made. At V2, eligible subjects were enrolled who were MTB users with a minimum plaque average screening score of ≥ 1.8 per Lobene and Soparker Modified Plaque Index (MPI). Enrolled subjects were randomized to a treatment sequence and dispensed products per randomization for an acclimation period, approximately 6 brushings, followed by a MTB washout period. Subjects returned for V3 efficacy evaluation and crossed over to the alternate treatment. Acclimation, washout and V4 efficacy assessments were repeated for the alternate treatment. Safety was characterized in intraoral exams and per medical history review. A mixed effect linear model was used to assess the plaque index reduction of each treatment group.
Result: One-hundred ten subjects were randomized in the study, there were 3 early terminations. The mean age for all randomized subjects was 44.3 years. The study included 94 females and 16 males. The treatment sequence groups were balanced for gender. The overall LSMean(SE) pre brushing MPI was 3.34(0.06) for PSFP and 2.38(0.06) for OTFA. Post-brushing values were 1.13(0.04) for PSFP and 1.38(0.04) for OTFA; p-value <0.001. Express as percent reduction, the values are 52.7% for PSFP and 42.1 for OTFA. The observed differences were also consistent in sub-region analysis (anterior, posterior, interproximal).
Conclusion:
PSFP was statistically significantly superior to OTFA in reducing surface plaque. Both products were safe for use.