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一项比较双颌前突病例中保持器的随机对照试验。

A randomized controlled trial comparing retainers in bimaxillary proclination cases.

作者信息

Maskim Nurulhuda, Mohd Tahir Norhidayah Nor Zahidah, Wan Hassan Wan Nurazreena

机构信息

Orthodontic Unit, Klinik Pergigian Pekan, Hospital Pekan, Ministry of Health Malaysia, Pekan, Pahang, 26600, Malaysia.

Department of Paediatric Dentistry and Orthodontic, Faculty of Dentistry, Universiti Malaya, Kuala Lumpur, 50603, Malaysia.

出版信息

Clin Oral Investig. 2025 Feb 6;29(2):117. doi: 10.1007/s00784-025-06199-3.

Abstract

INTRODUCTION

There is currently no recommendation for retaining corrected bimaxillary proclination cases. This study aimed to compare retention protocols for maintaining stability of such cases.

MATERIALS AND METHODS

In this single-center, single-blinded parallel control trial, 27 participants were assigned to three groups using block randomization with a 1:1:1 allocation ratio; fixed bonded retention (FBR), vacuum-formed retention (VFR), and dual retention (DR) comprising both types. Data were collected every 3-months from debond (T0) for 12 months (T4). The primary outcomes measured changes in soft and dental tissue parameters on traced lateral cephalograms. Secondary outcomes included intra-arch changes and the oral health impact profile (OHIP-14[M]). This trial was registered with Clinicaltrial.gov (NCT04578704).

RESULTS

At T4, the upper lip, lower lip, and upper incisors moved anteriorly (mean difference (MD) of 1.63 mm (SD 3.7), 0.48 mm (SD 1.1), and 0.54 mm (SD 0.97), respectively). The upper and lower incisors were proclined by 0.96 degrees (SD 2.1) and 1.11 degrees (SD 2.63), respectively. The interincisal angle was reduced by 0.56 degrees (SD 1.23). Only the upper incisor inclination (UII) change showed significant differences between groups (η² = 0.296; p = 0.015). Post-hoc comparisons revealed that the FBR and VFR groups exhibited greater proclination than the DR group (UII, MD = 3.33 degrees and 3.22 degrees, respectively). No differences were observed in OHIP-14[M] scores between the groups.

CONCLUSION

All three retention protocols showed statistically small but clinically insignificant changes.

CLINICAL RELEVANCE

Dual retention offers better control in preventing upper incisor proclination in bimaxillary proclination cases.

TRIAL REGISTRATION

This trial was registered with Clinicaltrial.gov (NCT04578704).

摘要

引言

目前尚无关于保留双颌前突矫治病例的建议。本研究旨在比较维持此类病例稳定性的保持方案。

材料与方法

在这项单中心、单盲平行对照试验中,27名参与者按1:1:1的分配比例通过区组随机化被分为三组;固定粘结保持(FBR)、真空成型保持(VFR)以及包含两种类型的联合保持(DR)。从拆除矫治器(T0)开始,每3个月收集一次数据,共收集12个月(T4)。主要观察指标为在描记的头颅侧位片上测量软组织和牙齿组织参数的变化。次要观察指标包括牙弓内变化和口腔健康影响程度量表(OHIP - 14[M])。本试验已在Clinicaltrial.gov注册(NCT04578704)。

结果

在T4时,上唇、下唇和上切牙向前移动(平均差值分别为1.63毫米(标准差3.7)、0.48毫米(标准差1.1)和0.54毫米(标准差0.97))。上切牙和下切牙分别前倾0.96度(标准差2.1)和1.11度(标准差2.63)。切牙间角度减小0.56度(标准差1.23)。仅上切牙倾斜度(UII)变化在组间显示出显著差异(η² = 0.296;p = 0.015)。事后比较显示,FBR组和VFR组比DR组表现出更大的前倾(UII,平均差值分别为3.33度和3.22度)。组间OHIP - 14[M]评分未观察到差异。

结论

所有三种保持方案在统计学上均显示出微小但临床上无显著意义的变化。

临床意义

联合保持在预防双颌前突病例的上切牙前倾方面提供了更好的控制。

试验注册

本试验已在Clinicaltrial.gov注册(NCT04578704)。

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