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一项为期 6 个月的随机对照试验,评估了一款新型智能连接振荡旋转牙刷与智能连接声波牙刷在减少菌斑和牙龈炎方面的效果。

A 6-month randomized controlled trial evaluating a novel smart-connected oscillating-rotating toothbrush versus a smart-connected sonic toothbrush for the reduction of plaque and gingivitis.

机构信息

All Sum Research Center Ltd, Mississauga, ON, Canada.

Procter & Gamble Service GmbH, Kronberg, Germany,

出版信息

Am J Dent. 2021 Feb;34(1):54-60.

Abstract

PURPOSE

This 6-month study compared the effects of a smart-connected oscillating-rotating (O-R) electric rechargeable toothbrush with micro-vibrations with those of a marketed smart-connected sonic rechargeable toothbrush for the reduction of gingivitis and plaque.

METHODS

In this single-center, examiner-blind, two-treatment, open-label, parallel-group, randomized study, 110 adult subjects with evidence of gingivitis and plaque were randomized to use either the O-R brush (Oral-B iO) or the sonic brush (Philips Sonicare DiamondClean). Both groups were instructed to brush twice daily with a standard sodium fluoride dentifrice. Gingivitis and plaque were assessed at baseline, week 1, and week 24 using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and the Rustogi Modification of the Navy Plaque Index (RMNPI). Designation of gingivitis case status as "healthy" or " not healthy" was made according to the World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.

RESULTS

A significantly greater percentage of subjects in the O-R brush group versus the sonic brush group transitioned from " not healthy" to " healthy" gingivitis case status at week 24 (96.4% vs. 81.8%; P= 0.029). The O-R toothbrush produced a significantly greater reduction in adjusted mean MGI score, adjusted mean GBI score, and adjusted mean number of bleeding sites than did the sonic brush (week 24, by 32.6% for MGI score, by 23.7% for GBI score, and by 26.1% for number of bleeding sites, P< 0.001). After a single use on day 1, plaque removal was statistically significantly greater for the O-R brush compared to the sonic brush (P< 0.001); by week 24, the O-R brush demonstrated greater reductions in whole mouth plaque (24.6%), gingival margin plaque (61.9%) and approximal region plaque 25.8% (P≤ 0.007 for all) compared to the sonic brush.

CLINICAL SIGNIFICANCE

This 6-month study provides evidence supporting use of a smart-connected O-R electric toothbrush with micro-vibrations for plaque removal and gingivitis reductions, resulting in transitions to a healthy gingival state.

摘要

目的

本为期 6 个月的研究比较了具有微振动功能的智能互联振荡旋转(O-R)电动可充电牙刷与市售智能互联声波可充电牙刷在减少牙龈炎和牙菌斑方面的效果。

方法

在这项单中心、 examiner 盲法、两治疗组、开放标签、平行组、随机研究中,110 名有牙龈炎和牙菌斑证据的成年受试者被随机分配使用 O-R 牙刷(Oral-B iO)或声波牙刷(Philips Sonicare DiamondClean)。两组均被指示使用含标准氟化物的牙膏每天刷牙两次。使用改良牙龈指数(MGI)、牙龈出血指数(GBI)和拉斯特吉海军菌斑指数改良版(RMNPI)在基线、第 1 周和第 24 周评估牙龈炎和牙菌斑。根据世界牙周病和种植体周围疾病与状况分类工作组的标准,将牙龈炎病例状态指定为“健康”或“不健康”。

结果

与声波牙刷组相比,O-R 牙刷组在第 24 周时从“不健康”牙龈炎病例状态转变为“健康”牙龈炎病例状态的受试者比例显著更高(96.4% vs. 81.8%;P=0.029)。O-R 牙刷在调整后的平均 MGI 评分、调整后的平均 GBI 评分和调整后的平均出血部位数量方面均显著优于声波牙刷(第 24 周时,MGI 评分降低 32.6%,GBI 评分降低 23.7%,出血部位数量降低 26.1%,P<0.001)。在第 1 天单次使用后,O-R 牙刷在去除牙菌斑方面的效果明显优于声波牙刷(P<0.001);到第 24 周时,O-R 牙刷在减少全口牙菌斑(24.6%)、牙龈缘牙菌斑(61.9%)和近中区域牙菌斑(25.8%)方面的效果均优于声波牙刷(所有 P 值均≤0.007)。

临床意义

这项为期 6 个月的研究提供了证据,支持使用具有微振动功能的智能互联 O-R 电动牙刷进行牙菌斑清除和牙龈炎减少,从而实现向健康牙龈状态的转变。

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