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

摘要

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.