The objective of this study was to assess the extent to which Philips Sonicare PowerUp (PSP) with ProResults Brush Head differs in single-use plaque reduction to ADA Reference Manual Toothbrush (MTB).
Method:
A randomized, examiner blinded parallel-design study was conducted in a population of healthy adults aged 18-65 years. At Visit 1, Informed Consent was obtained and subjects were screened. Eligible subjects were manual toothbrush users with a minimum plaque accumulation screening score of ≥ 1.8 per Modified Quigley Hein Plaque Index (MQH) examination. Enrolled subjects were randomized to a treatment group and dispensed products per randomization for an acclimation period of use, approximately 6 brushings, with PSP or MTB. Acclimation was followed by a wash-out period with MTB for both groups. Subjects returned for Visit2 efficacy evaluation at Day 7 (±1 day). An MQH score was assessed followed by supervised product use per randomization and post-brushing MQH score. Safety was characterized in intraoral exams and per medical history review. A mixed-model approach with the subject as random effect was used for statistical analysis.
Result:
One-hundred fifty-two subjects were randomized and completed the study, 76 subjects each in PSP and MTB groups (100 females, 52 males; mean age 42.6 years). Both groups were balanced for gender. LSMeans(SE) V2 pre-brushing MQH scores were 2.4(0.02) for PSP and 2.4(0.02) for MTB groups. Post brushing LSMeans(SE) MQH scores were 0.8(0.03) for PSP and 1.1(0.03) for MTB. The observed differences were also consistent in sub-region analysis (anterior, posterior, interproximal). All comparisons were statistically significant at p<.0001.
Conclusion:
PSP was statistically significantly superior to MTB in reducing surface plaque. Both products were safe for use.