Method: A randomized, multi-center, examiner-blinded, parallel-design study was conducted in a population of 179 healthy adults (124 females, 55 males) aged 18-65 years (mean age: 40), with existing stain, who consumed coffee, tea, tobacco and/or red-wine. Subjects provided informed consent and were pre-screened at Visit 1 (Day -1 to Day -7) for qualification. Subjects were to have 10 of 12 anterior teeth, buccal surface, available for assessment, with minimum total score of >8 (intensity x area) per Modified Lobene Stain Index (MSLI). Baseline stain values were recorded at Visit 2 (Day 0) following oral care abstention 3-6 hours prior, and eating, smoking abstention 2 hours prior. Enrolled subjects were then randomized to PSDC or MTB use twice daily. Subjects returned to clinic at Visit 3/Week 1 for an interim efficacy stain assessment and at Visit 4/Week 2 for final efficacy stain assessment. Statistical analysis was performed using a linear mixed effects model and between groups analysis was performed using the appropriate F-Test. Safety was assessed through medical history review and intraoral exam.
Result: One hundred seventy nine subjects completed the study. The mean(STD) baseline overall MLSI score for PSDC was 0.55(0.34) and for MTB 0.56(0.38). The change from baseline at Week 1 was 0.11(0.15) for PDSC and 0.05(0.16) for MTB. At Week 2, values were 0.18(0.18) and 0.11(0.18) for PDSC and MTB, respectively. Reductions from baseline for both treatment groups are statistically significant (p<0.05), as are between group comparisons at each time point (p<0.05). All products were safe for use.
Conclusion: PSDC power toothbrush reduced surface stain significantly more compared to baseline and to MTB use at one and two week assessment intervals.