改变治疗时间对颈椎头部矫形器治疗对面部骨骼变化影响的比较：一项随机对照试验。

Comparison of effects of cervical headgear treatment on skeletal facial changes when the treatment time is altered: a randomized controlled trial.

机构信息

Oral and Maxillofacial Department, Oulu University Hospital, Finland.

Department of Oral Development and Orthodontics, Research Unit of Oral Health Sciences, University of Oulu, Finland.

出版信息

Eur J Orthod. 2019 Nov 15;41(6):631-640. doi: 10.1093/ejo/cjz053.

DOI:10.1093/ejo/cjz053

PMID:31369675

Abstract

BACKGROUND

There is a lack of evidence based on longitudinal information in the field of Class II malocclusion management with cervical headgear (CH), especially in a randomized setting.

OBJECTIVES

The main objective of this study was to evaluate skeletal facial changes, particularly in vertical dimensions, after Kloehn-type CH treatment in children when the timing of treatment is altered.

TRIAL DESIGN

Prospective, parallel-group, randomized controlled trial.

METHODS

Screened children with Class II malocclusion were randomized in 1:1 ratio to two groups of equal size by sealed-envelope randomization: the early group (EG), where active CH treatment was started at the age of 7.8 years, and the late group (LG), where CH treatment was started at the age of 9.5 years. The active treatment was continued until normal Class I occlusion on first molars was achieved. Cephalograms were taken at three different time points. Changes in cephalometric measurements were compared between groups and genders. Blinding was applicable for outcome evaluation.

RESULTS

Of 67 randomized children, 56 completed the study. Upper face height increased during the CH treatment phase, as the parameter N-ANS increased significantly during the active treatments of EG (P < 0.05) and LG (P < 0.05). Also, the parameter NSL-PL increased significantly during the treatment of EG (P < 0.01) and during the treatment of LG (P < 0.01). The Gonial angle decreased significantly in the early CH treatment group compared to the later treatment group (T0-T2: P < 0.01). CH improved the antero-posterior jaw relationship. No harms were encountered.

CONCLUSIONS

Although the upper face height increased, the mandible showed anterior rotation after CH treatment. The Gonial angle was significantly decreased in the EG compared to the LG. There were gender-specific differences in both sagittal and vertical dimensions when examining interrelations in dimensional changes. The differences found between the early and later treatment groups were not clinically important when the cephalometric results are considered.

CLINICAL REGISTRATION

ClinicalTrials.gov (NCT02010346).

摘要

背景

在使用颈椎颅颌牵引（CH）矫正 II 类错颌方面，缺乏基于纵向信息的循证医学证据，特别是在随机设置中。

目的

本研究的主要目的是评估 Kloehn 型 CH 治疗后儿童的骨骼面部变化，特别是垂直方向的变化，同时改变治疗时机。

试验设计

前瞻性、平行组、随机对照试验。

方法

对筛查出的 II 类错颌儿童进行 1:1 随机分组，通过密封信封随机分组：早期组（EG），7.8 岁开始进行主动 CH 治疗；晚期组（LG），9.5 岁开始 CH 治疗。主动治疗持续到第一磨牙达到正常的 I 类咬合。在三个不同时间点拍摄头颅侧位片。比较两组和性别之间的头影测量变化。结果评估适用盲法。

结果

在 67 名随机分配的儿童中，有 56 名完成了研究。在 CH 治疗阶段，上面高增加，参数 N-ANS 在 EG（P<0.05）和 LG（P<0.05）的主动治疗期间显著增加。同时，参数 NSL-PL 在 EG 的治疗期间（P<0.01）和 LG 的治疗期间（P<0.01）显著增加。与后期治疗组相比，早期 CH 治疗组的下颌角明显减小（T0-T2：P<0.01）。CH 改善了颌骨前后关系。未发现任何危害。