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一项为期12周的随机临床对照试验,比较一款旋转振动牙刷与一款新型声波牙刷在减轻牙龈炎和牙菌斑方面的效果。

A randomized 12-week clinical comparison of an oscillating-rotating toothbrush to a new sonic brush in the reduction of gingivitis and plaque.

作者信息

Klukowska M, Grender J M, Conde E, Ccahuana-Vasquez Renzo Alberto, Goyal C R

出版信息

J Clin Dent. 2014;25(2):26-31.

Abstract

OBJECTIVE

To evaluate the efficacy of a marketed oscillating-rotating (O-R) power toothbrush (Oral-B Triumph with SmartGuide and FlossAction brush head, D34/EB25) to a new sonic toothbrush (Sonicare FlexCare Platinum) in the reduction of gingivitis and plaque over a 12-week test period.

METHODS

This was a single center, randomized, open label, examiner-blind, two-treatment, parallel group study. Subjects who met the entrance criteria were enrolled in the study and randomly assigned to either the O-R or sonic treatment group. Subjects brushed with their assigned toothbrush and a marketed fluoride dentifrice for two minutes twice daily at home for 12 weeks. Gingivitis and plaque were evaluated at Baseline, Week 6, and Week 12. Gingivitis was assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI), and plaque was assessed using the Rustogi Modified Navy Plaque Index (RMNPI). Data were analyzed using an Analysis of Covariance (ANCOVA) with Baseline as the covariate.

RESULTS

In total, 130 subjects (65 per group) were randomized to treatment and 127 subjects completed the study. Both brushes produced statistically significant (p < 0.001) reductions in gingivitis and plaque measures relative to Baseline. At Week 12, the O-R brush demonstrated significantly greater reductions than the sonic brush in whole mouth gingivitis measures (p = 0.007). Additionally, the O-R brush presented significantly fewer bleeding sites (p < 0.007) and significantly greater reductions in whole mouth plaque measures (p < or = 0.035) at Weeks 6 and 12 versus the sonic brush. The benefit for the O-R brush versus the sonic brush at Week 12 was 11.7% for gingivitis, 19.8% for number of bleeding sites, and 12.2% for whole mouth plaque. There were no adverse events reported or observed for either brush.

CONCLUSION

The oscillating-rotating toothbrush demonstrated statistically significantly greater reductions in whole mouth plaque at Weeks 6 and 12, as well as significantly greater gingivitis reductions over the long-term (12 weeks), compared to the new sonic toothbrush.

摘要

目的

在为期12周的测试期内,评估一款市售的振荡旋转(O-R)电动牙刷(配备SmartGuide和FlossAction刷头的欧乐-B佳洁士,D34/EB25)与一款新型声波牙刷(飞利浦Sonicare FlexCare Platinum)在减轻牙龈炎和牙菌斑方面的效果。

方法

这是一项单中心、随机、开放标签、检查者盲法、双治疗、平行组研究。符合入选标准的受试者被纳入研究,并随机分配到O-R或声波治疗组。受试者在家中每天使用指定的牙刷和市售含氟牙膏刷牙两次,每次两分钟,持续12周。在基线、第6周和第12周评估牙龈炎和牙菌斑情况。使用改良牙龈指数(MGI)和牙龈出血指数(GBI)评估牙龈炎,使用Rustogi改良海军牙菌斑指数(RMNPI)评估牙菌斑。以基线作为协变量,采用协方差分析(ANCOVA)对数据进行分析。

结果

共有130名受试者(每组65名)被随机分配接受治疗,127名受试者完成了研究。与基线相比,两种牙刷在减轻牙龈炎和牙菌斑指标方面均有统计学显著差异(p < 0.001)。在第12周时,O-R牙刷在全口牙龈炎指标方面的减轻程度明显大于声波牙刷(p = 0.007)。此外,在第6周和第12周时,与声波牙刷相比,O-R牙刷的出血部位明显更少(p < 0.007),全口牙菌斑指标的减轻程度明显更大(p ≤ 0.035)。在第12周时,O-R牙刷相对于声波牙刷在牙龈炎方面的优势为11.7%,出血部位数量方面为19.8%,全口牙菌斑方面为12.2%。两种牙刷均未报告或观察到不良事件。

结论

与新型声波牙刷相比,振荡旋转牙刷在第6周和第12周时全口牙菌斑的减轻程度在统计学上显著更大,并且在长期(12周)内牙龈炎的减轻程度也明显更大。

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