Inhibition and Removal of Calculus Deposits in a 3-Month Randomized Clinical Trial
Abstract
Kimberly R Milleman, Tori L York, Liora Levi, Zmira Silman and Jeffery L Milleman
Aim: To evaluate the safety and efficacy of ToothWave™ a novel RF-utilizing toothbrush for inhibition and removal of calculus deposits.
Methods: This was a single-blind, double arm prospective study. Subjects were randomized to one of two study groups, receiving either ToothWave™ or a control sonic vibrating toothbrush (Philips Sonicare 4100 Protective Clean), and performed twice-daily brushing during a test period of 12 weeks. Calculus was assessed at Baseline and again after 3, 6 and 12 weeks using the Volpe-Manhold Index (V-MI). Results were compared within each group between the different visits and between the groups; percent change from baseline was also compared between the groups. The differences between groups were compared using Mann Whitney non-parametric model. Differences within each group over time were compared using Friedman’s test followed by Dunn’s test.
Results: A total of 87 subjects (42 in the test group and 45 in the control) completed the study, having fully evaluable data. At Baseline, the groups did not differ significantly in the efficacy measurement mean scores. While the control group exhibited a statistically significant increase in calculus levels (p≤0.001) the test group maintained the original baseline levels and exhibited a slight negative percent change in the VMI score as compared to baseline (not significant). Both toothbrushes were well-tolerated and no device related adverse events were reported during the study.
Conclusions: The ToothWave™ RF-utilizing toothbrush demonstrated statistically significant calculus reductions when compared to a powered control toothbrush while maintaining the initial calculus levels and preventing the additional calculus accumulations.