Safety and efficacy of a novel toothbrush utilizing RF energy for the reduction of plaque, calculus and gingivitis.

PURPOSE To evaluate the safety and efficacy of the ToothWave radiofrequency (RF) toothbrush in the reduction of plaque, calculus and gingival inflammation, as compared to a standard powered toothbrush accepted by the American Dental Association (ADA). METHODS This was a single-blind, double arm, prospective study. Subjects were randomized to one of two treatment groups, receiving either the RF powered toothbrush or a control powered toothbrush, and performing twice daily brushing for a test period of 6 weeks. Plaque (RMNPI), calculus (V-MI), gingival inflammation (MGI) and bleeding (GBI) were assessed at baseline, after 4 and 6 weeks. Comparisons were completed both within and between each treatment group. Statistical analyses were conducted using the Mann Whitney non-parametric model. RESULTS 85 subjects completed the study and had fully evaluable data. No significant differences between the groups were found in the baseline scores (P≥ 0.165). Following 6 weeks, the RF test group demonstrated statistically significant reductions in plaque, gingivitis and calculus compared to the control powered toothbrush (P≤ 0.001). Both toothbrushes were well-tolerated and no device-related adverse events were reported. The RF-utilizing powered toothbrush produced statistically significant reductions in dental plaque, calculus deposition, gingival inflammation and gingival bleeding as compared to a control powered toothbrush. CLINICAL SIGNIFICANCE The RF powered toothbrush used twice daily resulted in an overall improvement in oral health.