Department of Orthodontics, Shanghai Stomatological Hospital & School of Stomatology, Fudan University, Shanghai, China.
Shanghai Key Laboratory of Craniomaxillofacial Development and Diseases, Fudan University, Shanghai, China.
Trials. 2022 Jun 7;23(1):476. doi: 10.1186/s13063-022-06389-4.
Orthodontic treatment is commonly more time-consuming in adults than in teenagers, especially when it comes to the maxillary en-masse retraction, which may take 9 months or even longer. As to solve this concern, orthodontists have been striving to seek new methods for shortening orthodontic treatment time. Piezocision, as a popular alternative treatment, has been widely used in different types of tooth movement. However, its effect on en-masse retraction of maxillary anterior teeth remains unclear. This randomized controlled trial intends to figure out the role piezocision plays in accelerating en-masse retraction.
This protocol is designed for a prospective, single-center, assessor-blinded and parallel-group randomized controlled trial. Twenty adult patients aged from 18 to 40 whose orthodontic treatment required bilateral maxillary first premolars extraction will be randomly assigned to the piezocision group and the control group at a ratio of 1:1. The piezocision group will undergo en-masse retraction immediately after the piezo surgery, while the control group will start en-masse retraction directly. Both groups will be followed up every 2 weeks to maintain the retraction force until the end of space closure. The space closing time is set as the primary endpoint. Meanwhile, the secondary endpoints include the change of root length, labial and palatal alveolar bone thickness, vertical bone height, probing depth of maxillary anterior teeth, cephalometric measurements, visual analogue scale, and postoperative satisfaction questionnaire.
This study will attempt to provide more convincing evidence to verify whether piezocision will shorten the time of en-masse retraction or not. Distinguished with previous studies, our study has made some innovations in orthodontic procedure and primary outcome measurement, aiming to clarify the efficacy and safety of piezocision-assisted en-masse retraction in Chinese population.
Chinese Clinical Trial Registry ChiCTR 1900024297 . Registered on 5 July 2019.
成人正畸治疗通常比青少年需要更多的时间，尤其是在进行上颌整体后移时，可能需要 9 个月甚至更长时间。为了解决这个问题，正畸医生一直在努力寻找缩短正畸治疗时间的新方法。超声骨刀切割作为一种流行的替代治疗方法，已广泛应用于不同类型的牙齿移动。然而，其对上颌前牙整体后移的效果尚不清楚。本随机对照试验旨在探讨超声骨刀切割在加速上颌前牙整体后移中的作用。
本方案设计为前瞻性、单中心、评估者盲法、平行组随机对照试验。将 20 名年龄在 18 至 40 岁之间、正畸治疗需要双侧上颌第一前磨牙拔除的成年患者按 1:1 的比例随机分为超声骨刀组和对照组。超声骨刀组在超声手术后立即进行上颌整体后移，对照组则直接开始上颌整体后移。两组均每 2 周随访一次，以维持后移力直至空间关闭结束。空间关闭时间设为主要终点。同时，次要终点包括根长变化、唇侧和腭侧牙槽骨厚度、垂直骨高度、上颌前牙探诊深度、头影测量、视觉模拟量表和术后满意度问卷。
本研究试图提供更有说服力的证据来验证超声骨刀切割是否能缩短上颌整体后移的时间。与以往的研究不同，本研究在正畸程序和主要结局测量方面进行了一些创新，旨在阐明超声骨刀辅助上颌整体后移在中国人群中的疗效和安全性。
中国临床试验注册中心 ChiCTR1900024297 。注册于 2019 年 7 月 5 日。
