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关于乳磨牙牙髓切断术药物的已发表研究的定性评估

Qualitative assessment of published studies on pulpotomy medicaments for primary molar teeth.

作者信息

Gopalakrishnan Vaishnavi, Anthonappa Robert, Ekambaram Manikandan, King Nigel M

机构信息

School of Dentistry, The University of Western Australia, Perth, Western Australia, Australia.

Department of Oral Sciences, Faculty of Dentistry, University of Otago, Dunedin, New Zealand.

出版信息

J Investig Clin Dent. 2019 May;10(2):e12389. doi: 10.1111/jicd.12389. Epub 2019 Jan 11.

Abstract

The aim of the present study was to perform a qualitative assessment of published clinical studies, using the Medline database between 2006 and 2016, on commonly used pulpotomy medicaments. Standardized criteria proposed by Fuks and Papagiannoulis in 2006 was used by three independent examiners who assessed a total of 64 studies and graded the papers as grades A (38-42), B1 (32-37), B2 (25-31), or C (<25) based on the score obtained. Dropout rates were calculated based on the initial sample and the final sample used for analysis. Only three papers were grade A, two of which were parts of the same clinical study with results presented at 24 and 42 months, respectively. Twelve papers were graded B1, 19 were graded B2, and 30 were graded C. The quality of evidence seemed greatest for formocresol (2 grade A, 21 grade B), followed by electro surgery (1 grade A study), calcium hydroxide (11 grade B studies), and ferric sulfate (11 grade B studies). The current qualitative assessment clearly highlights the inadequacies in the published studies, especially the study design and clinical and radiographic criteria, thus provides a basis for formulating specific guidelines for researchers embarking on conducting clinical trials on pulpotomy medicaments.

摘要

本研究的目的是利用2006年至2016年期间的Medline数据库,对已发表的关于常用牙髓切断术药物的临床研究进行定性评估。三名独立审查员采用了Fuks和Papagiannoulis在2006年提出的标准化标准,他们共评估了64项研究,并根据获得的分数将论文评为A(38 - 42)、B1(32 - 37)、B2(25 - 31)或C(<25)级。根据初始样本和用于分析的最终样本计算失访率。只有三篇论文为A级,其中两篇是同一临床研究的部分内容,结果分别在24个月和42个月时呈现。十二篇论文评为B1级,十九篇评为B2级,三十篇评为C级。证据质量似乎对甲醛甲酚最高(2篇A级,21篇B级),其次是电外科手术(1篇A级研究)、氢氧化钙(11篇B级研究)和硫酸铁(11篇B级研究)。当前的定性评估清楚地突出了已发表研究中的不足之处,特别是研究设计以及临床和影像学标准,从而为着手进行牙髓切断术药物临床试验的研究人员制定具体指南提供了依据。

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