Department of Orthodontics & Dentofacial Orthopedics, Government Dental College, Kottayam, Kerala, India.
Department of Orthodontics & Dentofacial Orthopedics, Annoor Dental College, Kerala, India.
J Orthod. 2023 Sep;50(3):276-286. doi: 10.1177/14653125231160570. Epub 2023 Mar 15.
The aim of the present study was to undertake a systematic review of the available evidence on the release of bisphenol-A (BPA) from thermoplastic materials used in the fabrication of clear aligners (CA).
Electronic databases, such as MEDLINE (via PubMed), Google Scholar, Scopus, Cochrane Library, Web of Science, OpenGrey, and the U.S. National Institute of Heath-Clinical Trials, were searched up to 27 October 2022. In vivo/in vitro studies that assessed the release of BPA from different thermoplastic CA materials, with or without a control group, were selected. The risk of bias (RoB) in the randomised controlled trials (RCT) and in vitro studies was assessed using the Cochrane RoB tool and the guidelines for the reporting of pre-clinical studies, respectively. The quality of evidence was determined using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) Pro tool.
Six studies were considered for review from a total of 1926 records. This included one RCT and five in vitro studies. Only two studies found leaching of BPA, while four did not report any traces. The RoB was found to be moderate to high. The GRADE evidence level ranged from low to very low. Five of the included studies were conducted in vitro. Significant heterogeneity among the included studies prevented a quantitative synthesis.
In light of the available conflicting evidence, BPA release from CAs can neither be confirmed nor denied. Safety remains questionable until high-quality in vivo trials prove otherwise.
PROSPERO CRD42022310434.
本研究旨在对现有关于制造透明矫正器（CA）时使用的热塑性材料中双酚 A（BPA）释放的证据进行系统综述。
截至 2022 年 10 月 27 日，检索了电子数据库，如 MEDLINE（通过 PubMed）、Google Scholar、Scopus、Cochrane 图书馆、Web of Science、OpenGrey 和美国国立卫生研究院-临床试验。选择了评估不同热塑性 CA 材料（有无对照组）中 BPA 释放的体内/体外研究。使用 Cochrane RoB 工具评估随机对照试验（RCT）和体外研究的偏倚风险（RoB），并分别使用临床前研究报告指南评估 RoB。使用推荐评估、发展和评估（GRADE）Pro 工具确定证据质量。
从总共 1926 条记录中，有 6 项研究被认为适合进行综述。这包括一项 RCT 和五项体外研究。只有两项研究发现了 BPA 的浸出，而四项研究则没有报告任何痕迹。RoB 被认为是中等到高度的。GRADE 证据水平从低到非常低不等。五项纳入的研究是在体外进行的。纳入研究之间存在显著的异质性，无法进行定量综合。
鉴于现有相互矛盾的证据，不能确认或否认 CA 中 BPA 的释放。在高质量的体内试验证明之前，安全性仍然存在疑问。
PROSPERO CRD42022310434。
