Belgal Priyanka, Mhay Sahil, Patel Vrunda, Nalliah Romesh P
School of Dentistry, University of Michigan, Ann Arbor, MI 48109, USA.
Dent J (Basel). 2023 Jul 17;11(7):174. doi: 10.3390/dj11070174.
Background-Direct-to-consumer (DTC) sequential aligners promote "teeth straightening" at a low cost and with added patient convenience. DTC sequential aligners have risen in popularity among the general public and sparked debate among dental professionals. Dental professionals argue that using these aligners without an in-person diagnosis and treatment planning protocol set by a licensed dentist or orthodontist may lead to adverse effects on teeth and surrounding structures. The objective of this study is to describe adverse clinical events associated with the use of DTC sequential aligners as reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (FDA MAUDE) database. Methods-We searched the MAUDE database from 1 January 2010 to 31 December 2020 for the product code of 'NXC' (sequential aligners). The year, type of adverse event, reporter occupation, and event description were noted. Results-651 reports associated with sequential aligners were found, of which 104 were related to DTC sequential aligners. Fifty-four adverse events were reported in 2019. From the event description, 41.3% comprised bite problems, 29.8% comprised orofacial pain, and 26.6% of patients had some form of periodontal sequelae. Furthermore, 69.2% of the patients followed up after an adverse event with a dentist not associated with DTC aligners. Conclusions-The use of DTC sequential aligners without dental supervision has led to oral health problems, as documented in the MAUDE database. Commonly reported adverse events include bite problems, pain, sensitivity, and periodontal disease, and some adverse events are irreversible.
背景——直接面向消费者（DTC）的序列式牙齿矫治器以低成本且为患者提供更多便利的方式来促进“牙齿矫正”。DTC序列式牙齿矫治器在普通大众中越来越受欢迎，并引发了牙科专业人士之间的争论。牙科专业人士认为，在没有由持牌牙医或正畸医生制定的面对面诊断和治疗计划方案的情况下使用这些矫治器，可能会对牙齿及周围结构可能会产生不良影响。本研究的目的是描述美国食品药品监督管理局（FDA）的制造商和用户设施设备经验（FDA MAUDE）数据库中报告的与使用DTC序列式牙齿矫治器相关的不良临床事件。方法——我们在2010年1月1日至2020年12月31日期间的MAUDE数据库中搜索“NXC”（序列式矫治器）的产品代码。记录年份、不良事件类型、报告者职业和事件描述。结果——共发现651份与序列式矫治器相关的报告，其中104份与DTC序列式矫治器有关。2019年报告了54起不良事件。从事件描述来看，41.3%包括咬合问题，29.8%包括口面部疼痛，26.6%的患者有某种形式的牙周后遗症。此外，69.2%的患者在出现不良事件后找了与DTC矫治器无关的牙医进行随访。结论——如MAUDE数据库所记录的，在没有牙科监督的情况下使用DTC序列式牙齿矫治器会导致口腔健康问题。常见报告的不良事件包括咬合问题、疼痛、敏感和牙周疾病，而且一些不良事件是不可逆的。
