Method: An Ethics approved, randomized, examiner-blinded, 4-visit, cross-over design study was conducted in a population of healthy adults. At Visit 1, subjects provided informed consent and were screened for initial eligibility. At Visit 2, eligibility was completed including a minimum plaque score of >1.8 per Lobene and Soparker Modified Plaque Index (MPI). Subjects were then randomized to a treatment sequence, dispensed products for home-use and instructed on use for either PSDC or OBTZ. Subjects used the assigned product twice daily for 6 brushings followed by a Manual Toothbrush (MTB) washout. All subjects used Crest Cool Mint Gel Toothpaste. Subjects returned for Visit 3 efficacy evaluation 7 days (+/- 1 day) following Visit 2 with 24hours plaque accumulation. An MPI score was assessed followed by 2-minute supervised product use per randomization and post-brushing MPI score. Subjects then crossed to the second sequence per randomization and repeated the home-use procedures with the alternate test product followed by MTB washout. Visit 4 was completed 7 days (+/- 1 day) following Visit 3 and included pre and post brushing MPI assessments. Safety was characterized in intraoral exams and per subject diary report.
Result:
One-hundred twelve subjects were enrolled in the study (90 females, 22 males; mean age 39.4 years). Overall LSMean(SE) pre-brushing plaque scores were 2.4(0.03) for PSDC and 2.4(0.03) for OBTZ; post-brushing values were 0.4(0.03) for PSDC and 0.5(0.03) for OBTZ. The observed difference is statistically significant, p-value 0.0006. Expressed as percent reduction, the values are 83.0% for PSDC and 78.7% for OBTZ.
Conclusion:
PSDC power toothbrush was observed to be statistically significantly superior to OBTZ in reducing surface plaque. Both products were safe for use.