聚醚醚酮（PEEK）与超弹性同轴粘结保持器的对比：一项随机临床试验。第 1 部分。稳定性、保持器失败和患者满意度。

Poly-ether-ether-ketone (PEEK) versus dead-soft coaxial bonded retainers: a randomized clinical trial. Part 1. Stability, retainer failure, and participant satisfaction.

机构信息

Department of Orthodontics, College of Dentistry, University of Baghdad, Bab Al Muadham, Baghdad, Iraq.

出版信息

Eur J Orthod. 2024 Oct 1;46(5). doi: 10.1093/ejo/cjae044.

DOI:10.1093/ejo/cjae044

PMID:39206494

Abstract

BACKGROUND

Poly-ether-ether-ketone (PEEK) was introduced in dentistry as an alternative to metal alloys.

OBJECTIVE

To assess the effectiveness of PEEK-fixed retainers in preserving the stability of mandibular anterior and participant satisfaction as compared to the Dead-soft coaxial fixed retainer (DSC).

TRIAL DESIGN

A single-centre, two-arm parallel groups randomized clinical trial.

METHODS

The patients treated with pre-adjusted orthodontic appliances who have a Little's Irregularity Index (LII) ≤ 0.5 mm have been enrolled in the trial. PEEK retainers were prepared to round 0.8 mm wire by computer-aided design and manufacturing, and the DSC wire was carefully adapted to the lingual surface of the lower anterior teeth. The primary outcome was the stability of lower anterior teeth as assessed by LII, while the secondary outcomes were changes in occlusal parameters, retainer failure, and patient satisfaction. The data were collected at the debonding stage (T0), 1 month (T1), 3 months (T3), and 6 months (T6) after starting the trial, except for patient's satisfaction, which was recorded using an electronic form at T1 and T6.

BLINDING

Single blinding of participants.

RESULTS

A total of 46 participants with an age range of 12-28 years old were randomly allocated to the two groups (n = 23 in each). Only one participant dropped out; therefore, 45 participants were analysed. The DSC group showed a significant increase in LII at T3. Both retainer groups had comparable occlusal measurements, failure frequency, and survival time, with no significant difference. The patients in the DSC group reported a statistically significant perception of change in the position of their teeth compared to those in the PEEK group.

HARMS

No harmful effects have been reported.

LIMITATIONS

Limited follow-up duration and the inability to blind the operator due to the nature of the intervention.

CONCLUSIONS

After 6-month retention, the PEEK retainer was equally effective to DSC retainers in maintaining the teeth alignment, with no significant differences regarding the failure frequency, survival rate, and general patient satisfaction.

TRIAL REGISTRATION

https://register.clinicaltrials.gov. (NCT05557136).

摘要

背景

聚醚醚酮（PEEK）作为金属合金的替代品被引入牙科。

目的

评估 PEEK 固位体在保持下颌前牙稳定性和患者满意度方面的效果，与死软同轴固位体（DSC）相比。

试验设计

单中心、双臂平行组随机临床试验。

方法

本试验纳入了接受预调整正畸矫治器治疗且 Little 不调指数（LII）≤0.5mm 的患者。通过计算机辅助设计和制造，制备 PEEK 保持器以适应 0.8mm 圆丝，而 DSC 丝则仔细适应下颌前牙的舌面。主要结局是通过 LII 评估下颌前牙的稳定性，次要结局是咬合参数的变化、保持器失败和患者满意度。数据在脱粘阶段（T0）、1 个月（T1）、3 个月（T3）和 6 个月（T6）收集，除了患者满意度，这是在 T1 和 T6 使用电子表格记录的。

盲法

对参与者进行单盲。

结果

共纳入 46 名年龄在 12-28 岁之间的患者，随机分为两组（每组 23 名）。仅有 1 名患者退出，因此，45 名患者纳入分析。DSC 组在 T3 时 LII 显著增加。两组保持器的咬合测量、失败频率和生存时间相似，无显著差异。DSC 组的患者报告其牙齿位置感知发生变化，与 PEEK 组相比有统计学意义。