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一项为期3个月的临床研究,比较一款新型电动牙刷(博朗欧乐B 3D牙菌斑清除器)与手动牙刷的安全性和有效性。

A 3-month clinical investigation comparing the safety and efficacy of a novel electric toothbrush (Braun Oral-B 3D Plaque Remover) with a manual toothbrush.

作者信息

Cronin M, Dembling W, Warren P R, King D W

机构信息

NISCO, Northfield, NJ 08225, USA.

出版信息

Am J Dent. 1998 Sep;11(Spec No):S17-21.

PMID:10530095
Abstract

PURPOSE

To compare the efficacy and safety of a novel electric toothbrush (Braun Oral-B 3D Plaque Remover) with a standard reference ADA manual toothbrush.

MATERIALS AND METHODS

114 subjects were included in a 3-month randomized, parallel group, examiner-blind study and divided into two groups: 3D users and manual toothbrush users. Subjects were instructed to brush twice daily for 2 minutes. Evaluation of oral soft and hard tissue for safety, plaque, gingivitis and bleeding was conducted prior to the start of product use (at baseline), at days 14 and 35, and at 3 months.

RESULTS

105 subjects (55 3D users and 50 manual toothbrush users) completed the study. At days 14, 35 and at 3 months both groups showed reductions from baseline in whole mouth plaque, gingivitis and bleeding that were statistically significant (P < 0.005), except in the case of plaque at day 35 in manual toothbrush users. At 3 months, reductions for whole mouth plaque, gingivitis and bleeding were 15%, 16% and 65%, for 3D users and 8%, 12% and 56%, for manual toothbrush users, respectively. Group differences were significant (P < 0.05) in favor of the 3D with respect to plaque reduction for the whole mouth and for interproximal and anterior lingual sites at all three time periods. With respect to gingivitis, reductions for the whole mouth and interproximal and posterior lingual sites at 3 months were significantly greater in the 3D group. There was no clinically significant soft or hard tissue abrasion in either group. In conclusion, the 3D electric toothbrush was found to be safe and had increased efficacy with respect to reduction of plaque and gingivitis compared to a manual toothbrush.

摘要

目的

比较一款新型电动牙刷(博朗欧乐 - B 3D牙菌斑清除器)与标准参考美国牙医学会(ADA)手动牙刷的疗效和安全性。

材料与方法

114名受试者参与了一项为期3个月的随机、平行组、检查者盲法研究,分为两组:3D电动牙刷使用者和手动牙刷使用者。受试者被要求每天刷牙两次,每次2分钟。在产品使用开始前(基线时)、第14天、第35天和3个月时,对口腔软组织和硬组织进行安全性、牙菌斑、牙龈炎和出血情况的评估。

结果

105名受试者(55名3D电动牙刷使用者和50名手动牙刷使用者)完成了研究。在第14天、第35天和3个月时,两组全口牙菌斑、牙龈炎和出血情况与基线相比均有统计学意义的降低(P < 0.005),手动牙刷使用者在第35天时牙菌斑情况除外。3个月时,3D电动牙刷使用者全口牙菌斑、牙龈炎和出血情况的降低分别为15%、16%和65%,手动牙刷使用者分别为8%、12%和56%。在所有三个时间段,3D电动牙刷在全口牙菌斑减少方面,以及在邻面和舌面近中部位的牙菌斑减少方面,组间差异显著(P < 0.05),有利于3D电动牙刷组。对于牙龈炎,3D电动牙刷组在3个月时全口、邻面和舌面后部部位的减少幅度明显更大。两组均未出现具有临床意义的软组织或硬组织磨损。总之,与手动牙刷相比,3D电动牙刷被发现是安全的,并且在减少牙菌斑和牙龈炎方面具有更高的疗效。

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