成人安氏II类错牙合畸形中上颌微螺钉支抗磨牙远移矫治器与透明矫治器的疗效评估：一项随机对照试验的研究方案

Evaluation of maxillary miniscrew-anchored molar distalization appliance versus clear aligners in adult with Class II malocclusion: study protocol for a randomized controlled trial.

作者信息

Liu Hao, Tang Ziyan, Gong Zhicheng, Ye Cui, Wu Haimiao

机构信息

Department of Orthodontics, Shanghai Stomatological Hospital, Fudan University, No.356 Beijing East Road, Shanghai, China.

Department of Dental Technology, Shanghai Stomatological Hospital, Fudan University, Shanghai, China.

出版信息

Trials. 2025 Apr 7;26(1):123. doi: 10.1186/s13063-025-08827-5.

DOI:10.1186/s13063-025-08827-5

PMID:40197334

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11974175/

Abstract

BACKGROUND

Angle Class II malocclusion typically presents with overbite, distal molar relationship, and crowding of the upper anterior teeth. The distal movement of the maxillary molars is considered an optimal treatment strategy, as it can circumvent the need for orthodontic extraction. Clear aligners are currently used for molar distalization. However, this approach is not without its limitations, including the loss of anterior tooth anchorage and an extended treatment duration. To address these issues, this study introduces a novel molar distalization appliance. A clinical randomized controlled trial will compare the efficacy of this appliance with clear aligners, specifically assessing differences in the rate of tooth movement.

METHODS

This study will recruit 30 patients aged 18-35 with Angle Class II malocclusion, characterized by distal molar relationship, mild to moderate crowding, or protrusion of anterior teeth. Patients will be randomly divided into two groups: the experimental group using a novel molar distalization appliance, and the control group using clear aligners for molar distalization. Both groups will use orthodontic miniscrews as an anchorage, with elastic traction for molar distalization. Cone-beam CT and digital dental models will be collected before orthodontic intervention and after molar distalization for all samples. This study will register pre- and post-treatment images using maxillary bone structures and then analyze three-dimensional tooth movement. The study will further calculate the distance of molar distal movement per unit time as the tooth movement rate and compare whether there is a difference between the experimental and control groups.

DISCUSSION

This randomized controlled trial will serve as evidence that the novel molar distalization device, compared to clear aligners, whether offers advantages such as shorter treatment duration and superior control of tooth movement. It can provide a novel method for orthodontic clinical treatment of patients with Angle Class II malocclusion.

TRIAL REGISTRATION

ClinicalTrials.gov ChiCTR2300069122. Registered on 7 March 2023.

摘要

背景

安氏II类错牙合通常表现为深覆牙合、磨牙远中关系以及上前牙拥挤。上颌磨牙远移被认为是一种理想的治疗策略，因为它可以避免正畸拔牙的需要。目前，透明矫治器被用于磨牙远移。然而，这种方法并非没有局限性，包括前牙支抗丧失和治疗时间延长。为了解决这些问题，本研究引入了一种新型磨牙远移矫治器。一项临床随机对照试验将比较该矫治器与透明矫治器的疗效，特别评估牙齿移动速率的差异。

方法

本研究将招募30名年龄在18 - 35岁之间的安氏II类错牙合患者，其特征为磨牙远中关系、轻度至中度拥挤或前牙前突。患者将被随机分为两组：实验组使用新型磨牙远移矫治器，对照组使用透明矫治器进行磨牙远移。两组均使用正畸微螺钉作为支抗，通过弹性牵引进行磨牙远移。所有样本在正畸干预前和磨牙远移后均采集锥形束CT和数字化牙模型。本研究将使用上颌骨结构对治疗前后的图像进行配准，然后分析三维牙齿移动情况。该研究将进一步计算单位时间内磨牙远移的距离作为牙齿移动速率，并比较实验组和对照组之间是否存在差异。