Method:
An Ethics-approved, randomized, parallel, 3-visit clinical trial was conducted in healthy adults who were routine manual toothbrush (MTB) users. At Visit 1, subjects provided informed consent and were then screened for initial study eligibility. Subjects returned at Visit 2 with 24 hours plaque accumulation and were required to have a minimum average plaque score, per Lobene and Soparker Modified Plaque Index (MPI), of >1.8 to proceed on study. Eligible subjects were then randomized to a treatment group, either PSDC or CPCA, for a home use acclimation period. Subjects were to use the assigned product twice daily for 6 brushings followed by an MTB washout. All subjects used Crest Cool Mint Gel toothpaste. Subjects returned to clinic 7 days (+/-1 day) after Visit 2 for the final Visit 3 efficacy assessment. Subjects presented with 24 hours plaque accumulation and the blinded Examiner performed an MPI assessment. Subjects then used the assigned product per randomization and the Examiner completed a post-use MPI assessment. Safety was evaluated per intraoral exam and by subject diary report.
Result:
One-hundred forty two subjects were randomized in the study, 71 in PSDC group and 71 in CPCA group. The mean age of subjects was 43.7 years, 120 subjects were female, and 22 subjects were male. The Overall LSMean(SE) pre-brushing MPI was 2.48(0.06) for PSDC and 2.56(0.06) for CPCA. Post-brushing values were 1.16(0.05) for PSDC and 1.98(0.05) for CPCA; p-value <0.0001. Expressed as percent reduction, the values are 54.3% for PSDC and 22.8% for CPCA.
Conclusion:
PSDC power toothbrush was statistically significantly superior to CPCA in reducing surface plaque. Both products were safe for use.