Method: A two-phase randomized, examiner blinded parallel-design study was conducted in healthy adults aged 18-65 years. At Phase1/Visit 1, Informed Consent was obtained and subjects were screened. Eligible subjects were manual toothbrush users with a plaque accumulation score of ≥1.8 per Modified Quigley Hein Plaque Index (MQH). Enrolled subjects were randomized and dispensed study products for an acclimation period, approximately 6 brushings x 3 days, with either PSE or PL. An MTB washout period followed until Visit 2/Day 7. MQH score was assessed followed by supervised product use and post-brushing MQH score. Thereafter, subjects entered Phase II and all subjects received a new PSE brush head for 3-month home use. At V3/Month 3 subjects returned for an MQH score, followed by randomization, supervised product use of either new or home-use PSE brush head and a final MQH score. Safety was characterized in intraoral exams and per subject diary report. A mixed effect linear model was used for statistical analysis.
Result: One-hundred forty seven subjects completed Phase I and 140 subjects completed Phase II of the study, mean age 40.6 and 40.3 years respectively. For Phase I, PSE versus PL LSMean(SE) plaque reduction overall was 1.4(0.05) and 0.7(0.05), respectively (p<.0001). For Phase II, PSE new versus home-use LS Mean(SE) plaque reduction overall, was 1.26(0.05) and 0.90(0.05), respectively (p<.0001). The observed differences were consistent in sub-region analysis (anterior, posterior, interproximal).
Conclusion: PSE removed significantly more plaque than PL. PSE new removed significantly more plaque than PSE home-use. All products were safe for use.