使用Alt-RAMEC对混合式扩弓器-面罩与混合式扩弓器-颏板矫治方案进行上颌前牵引的长期比较：一项5年随机对照试验。

Long-term comparison of maxillary protraction with hybrid hyrax-facemask vs. hybrid hyrax-mentoplate protocols using Alt-RAMEC: a 5-year randomized controlled trial.

作者信息

Meyns Joeri, Meewis Jeroen, Dons Flore, Schreurs Arnoud, Aerts Johan, Shujaat Sohaib, Politis Constaninus, Jacobs Reinhilde

机构信息

Department of Oral and Maxillofacial surgery, General Hospital St-Jan, Synaps park 1, 3600 Genk, Belgium.

Department of Imaging and Pathology, OMFS-IMPATH Research Group, Faculty of Medicine KU Leuven, Kapucijnenvoer 33, 3000 Leuven, Belgium.

出版信息

Eur J Orthod. 2025 Feb 7;47(2). doi: 10.1093/ejo/cjaf011.

DOI:10.1093/ejo/cjaf011

PMID:40105065

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11920792/

Abstract

BACKGROUND

The study aimed to compare the short- and long-term effectiveness of hybrid Hyrax (HH) -Facemask (FM) and HH-mentoplate (MP) treatment protocols for maxillary protraction using Alt-RAMEC.

METHODS

A single-center 2-arm parallel randomized controlled trial. Participants: 28 skeletal class III patients (female: 14, male: 14; average age: 9.7 ± 1.3 years;) were included. Interventions: Two treatment groups where protraction therapy was combined with Alt-RAMEC. Group 1: Facemask group (Hybrid Hyrax + Facemask) and Group 2: Mentoplate group (Hybrid Hyrax + Mentoplate). Objective: To compare skeletal and dental changes between groups using low dose computed tomography (CT) scan from which virtual lateral cephalograms were generated. Outcome: Outcomes include changes in Wits appraisal (primary outcome), and cephalometric analysis of skeletal and dental changes (secondary outcomes) at 1 year and 5 years after treatment initiation. Randomization: 28 patients were allocated to either treatment-protocols using sequentially numbered opaque, sealed envelopes. The randomization sequence was generated with a 1:1 allocation ratio. Blinding: Due to the nature of the trial, the operator and children could not be blinded to the treatment allocation. However, blinding was used when assessing the outcomes.

RESULTS

Follow-up: one patient was lost at the one-year follow-up and an additional three patients were lost at the 5-year follow-up. Outcomes: Both treatment protocols effectively improved intermaxillary relationship. Wits measurements showed improvements of 4.42 mm (FM) and 2.86 mm (MP) at T1, decreasing slightly to 3.33 mm (FM) and 1.50 mm (MP) at T2. While vertical control and incisor inclination were comparable between groups long-term, short-term differences were noted in upper and lower incisor inclination. Results remained equally stable after five years (T2). Harms: minor harms were encountered with the anchor hooks (fracture or mucosal irritation), however none led to treatment cessation.

CONCLUSIONS

Early class III treatment with HH + MP provided similar outcomes and stability to that of HH + FM suggesting that the choice between FM and MP should be based on individual patient factors rather than presumed mechanical advantages.

TRIAL REGISTRATION

Clinical Trials ID: NCT02711111.

摘要

背景

本研究旨在比较使用Alt - RAMEC的混合式Hyrax（HH）-面罩（FM）和HH - 颏板（MP）治疗方案对上颌前牵引的短期和长期疗效。

方法

一项单中心双臂平行随机对照试验。参与者：纳入28例骨性III类患者（女性14例，男性14例；平均年龄：9.7±1.3岁）。干预措施：两个治疗组，前牵引治疗与Alt - RAMEC联合使用。第1组：面罩组（混合式Hyrax + 面罩）和第2组：颏板组（混合式Hyrax + 颏板）。目的：使用低剂量计算机断层扫描（CT）扫描比较两组之间的骨骼和牙齿变化，通过扫描生成虚拟侧位头影测量片。结果：结果包括治疗开始后1年和5年时Wits评估变化（主要结果）以及骨骼和牙齿变化的头影测量分析（次要结果）。随机分组：28例患者使用顺序编号的不透明密封信封分配至两种治疗方案之一。随机分组序列以1:1的分配比例生成。盲法：由于试验性质，操作者和儿童无法对治疗分配进行盲法处理。然而，在评估结果时采用了盲法。

结果

随访：1例患者在1年随访时失访，另外3例患者在5年随访时失访。结果：两种治疗方案均有效改善了颌间关系。Wits测量显示在T1时，FM组改善了4.42 mm，MP组改善了2.86 mm，在T2时略有下降，FM组为3.33 mm，MP组为1.50 mm。虽然两组长期的垂直控制和切牙倾斜度相当，但在上下切牙倾斜度方面存在短期差异。五年后（T2）结果同样稳定。不良事件：锚钩出现了轻微不良事件（骨折或黏膜刺激），但均未导致治疗中断。