Inhibition and Removal of Calculus Deposits in a 3-Month Randomized Clinical Trial

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引用次数: 1

Abstract

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.
一项为期3个月的随机临床试验:抑制和清除结石沉积物
目的:评价一种新型射频牙刷牙石沉积抑制和清除的安全性和有效性。方法:这是一项单盲、双臂前瞻性研究。受试者被随机分为两个研究组,接受牙波™或对照声波振动牙刷(Philips Sonicare 4100 Protective Clean),并在12周的测试期间每天刷牙两次。在基线和3,6和12周后使用Volpe-Manhold指数(V-MI)再次评估微积分。比较各组内不同访视及组间访视结果;与基线相比,各组之间的百分比变化也进行了比较。采用Mann - Whitney非参数模型比较各组间差异。每个组内随时间的差异分别用Friedman的测试和Dunn的测试进行比较。结果:共有87名受试者(试验组42名,对照组45名)完成了研究,数据完全可评估。在基线时,两组在疗效测量平均得分上没有显著差异。虽然对照组在微积分水平上有统计学意义上的显著增加(p≤0.001),但试验组保持原来的基线水平,并且与基线相比,VMI评分有轻微的负百分比变化(无统计学意义)。两种牙刷耐受性良好,在研究期间没有器械相关的不良事件报告。结论:与动力控制牙刷相比,使用牙波™rf的牙刷在保持初始牙石水平和防止额外的牙石积累的同时,统计上显示出显著的牙石减少。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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