Loguercio Alessandro Dourado, Maran Bianca Medeiros, Hanzen Taíse Alessandra, Paula Alexandra Mara de, Perdigão Jorge, Reis Alessandra
Universidade Estadual de Ponta Grossa - UEPG, School of Dentistry, Department of Restorative Dentistry, Ponta Grossa, Paraná, Brazil.
University of Minnesota, Department of Restorative Sciences, Minneapolis, MN, United States of America.
Braz Oral Res. 2017 Aug 28;31(suppl 1):e60. doi: 10.1590/1807-3107BOR-2017.vol31.0060.
We reviewed the literature to evaluate: a) The compliance of randomized clinical trials (RCTs) on bleaching with the CONSORT; and b) the risk of bias of these studies using the Cochrane Collaboration risk of bias tool (CCRT). We searched the Cochrane Library, PubMed and other electronic databases, to find RCTs focused on bleaching (or whitening). The articles were evaluated in compliance with CONSORT in a scale: 0 = no description, 1 = poor description and 2 = adequate description. Descriptive analyses of the number of studies by journal, follow-up period, country and quality assessments were performed with CCRT for assessing risk of bias in RCTs. 185 RCTs were included for assessment. More than 30% of the studies received score 0 or 1. Protocol, flow chart, allocation concealment and sample size were more critical items, as 80% of the studies scored 0. The overall CONSORT score for the included studies was 16.7 ± 5.4 points, which represents 52.2% of the maximum CONSORT score. A significant difference among journal, country and period of time was observed (p < 0.02). Only 7.6% of the studies were judged at "low" risk; 62.1% were classified as "unclear"; and 30.3% as "high" risk of bias. The adherence of RCTs evaluating bleaching materials and techniques to the CONSORT is still low with unclear/high risk of bias.
a）关于漂白的随机临床试验（RCT）对《CONSORT声明》的遵循情况；b）使用Cochrane协作网偏倚风险工具（CCRT）评估这些研究的偏倚风险。我们检索了Cochrane图书馆、PubMed及其他电子数据库，以查找聚焦于漂白（或美白）的RCT。文章依据《CONSORT声明》进行评估，评分标准为：0 = 未描述，1 = 描述不佳，2 = 描述充分。采用CCRT对按期刊、随访期、国家分类的研究数量进行描述性分析，并进行质量评估，以评估RCT中的偏倚风险。共纳入185项RCT进行评估。超过30%的研究得分为0或1。方案、流程图、分配隐藏和样本量是更关键的项目，因为80%的研究得分为0。纳入研究的《CONSORT声明》总体得分为16.7 ± 5.4分，占《CONSORT声明》最高得分的52.2%。在期刊、国家和时间段之间观察到显著差异（p < 0.02）。只有7.6%的研究被判定为“低”风险；62.1%被归类为“不清楚”；30.3%为“高”偏倚风险。评估漂白材料和技术的RCT对《CONSORT声明》的遵循率仍然较低，且存在不清楚/高偏倚风险。
