Clinical Performance of a Manual Brush With Tapered Bristle Technology

Objectives: To evaluate the gingivitis and plaque reduction efficacy of a new manual toothbrush with tapered bristles technology against a positive control manual brush.
Methods: This was an examiner-blind, two-week, two-treatments, parallel group, randomized study design evaluating a manual toothbrush with tapered bristles (Test, OM169) against a marketed manual toothbrush with regular bristles (Positive Control, Curaprox ultra soft 5460). Sixty subjects with gingivitis and plaque participated in this study. Gingivitis and plaque levels were assessed at baseline and after two weeks of use. Mazza Index (GI) and Rustogi Modified Navy Plaque Index (RMNPI) were used for gingivitis and plaque assessments, respectively. Tooth brushing was performed twice per day for two weeks in a regular manner using a standard fluoridated dentifrice. Changes from baseline after 2 weeks of use were compared for gingivitis and plaque. In addition, the single-use pre-/post-brushing effect was compared for plaque at the baseline visit. Statistical analyses were carried out using an analysis of covariance.
Results: Both brushes reduced gingivitis (0.283 for Test and 0.190 for Control) and the number of bleeding sites (7.839 for Test and 4.756 for Control) relative to baseline after 2 weeks of use (p<0.05). The Test brush demonstrated significantly greater reduction in gingivitis (p=0.04) and the number of bleeding sites (p=0.0189) than the Control brush. Both brushes significantly reduced plaque relative to Baseline in the single use (0.036 for Test and 0.068 for Control) and the 2-weeks assessments (0.060 for Test and 0.093 for Control) (p<0.05). The Control brush performed significantly better than the Test brush in the single-use and after 2-weeks plaque assessments (p<0.05).
Conclusions: The Test manual brush demonstrated greater gingivitis reduction compared to a marketed control manual brush after 2 weeks of use despite the control brush reducing more plaque. Differences in mechanisms of action may contribute to these outcomes.