Method: This was a single-center, examiner-blinded, parallel group, randomized clinical trial. One-hundred adult volunteers with baseline pre-brushing Rustogi-Modified Navy Plaque Index (RMNPI) score of ≥ 0.50 following 12 hours of no oral hygiene were randomized to one of two treatments: 1) new manual toothbrush with 5 cleaning zones (Oral-B 5-Way Clean) as a test brush and 2) flat-trim manual brush (ADA manual) as a negative control. Subjects brushed with the assigned brush and cavity protection toothpaste (Crest Cavity Protection) for 1 min, 2x/day in a customary manner for 4 weeks. RMNPI assessments were conducted pre-brushing at Baseline and post-brushing at Week 4. Week 4 plaque removal scores were analyzed for treatment differences using ANCOVA with respective baseline RMNPI score as the covariate.
Result: Mean age was 37.1 years, ranging from 19 to 80, and 61% of subjects were female. Groups were balanced (p > 0.5) with respect to demographic parameters and Baseline whole-mouth RMNPI scores, with the mean Baseline RMNPI score of 0.603 and 0.602 for the test and the negative control brush, respectively. Both products demonstrated significant (p < 0.001) reduction in Week 4 post-brushing whole-mouth RMNPI scores relative to Baseline. Use of a test toothbrush resulted in 31% greater reduction (p = 0.001) in Week 4 whole-mouth RMNPI scores relative to the negative control. Additionally, use of this test toothbrush resulted in 35.5% and 22.5% greater reduction (p <0.05) in Week 4 interproximal and gingival margin RMNPI scores, respectively, relative to the negative control.
Conclusion: New manual toothbrush is shown to be more effective than a regular manual toothbrush in removing plaque following 4-weeks of product use.