一项关于0.018英寸和0.022英寸槽沟正畸托槽系统有效性的随机临床试验：第1部分——治疗持续时间

A randomized clinical trial of the effectiveness of 0.018-inch and 0.022-inch slot orthodontic bracket systems: part 1-duration of treatment.

作者信息

Yassir Yassir A, El-Angbawi Ahmed M, McIntyre Grant T, Revie Gavin F, Bearn David R

机构信息

Orthodontic Department, School of Dentistry, University of Dundee, UK.

Orthodontic Department, College of Dentistry, University of Baghdad, Iraq.

出版信息

Eur J Orthod. 2019 Mar 29;41(2):133-142. doi: 10.1093/ejo/cjy037.

DOI:10.1093/ejo/cjy037

PMID:30007300

Abstract

OBJECTIVE

To compare treatment duration between 0.018-inch and 0.022-inch slot systems and determine factors influencing treatment duration.

SUBJECTS AND METHODS

Eligible participants aged 12 years or over were allocated to the 0.018-inch or 0.022-inch slot MBT appliance (3M-Unitek, Monrovia, California, USA) using block randomization in groups of 10. Outcome measures included duration of: 1. overall treatment, 2. levelling and alignment, 3. working and finishing, and 4. appointment numbers and other treatment-related factors. Parametric tests (independent samples t-test) and non-parametric tests (chi-square with Fisher's exact tests and Mann-Whitney U-test) assessed differences between groups. A multiple linear regression analysis identified factors influencing treatment duration (P < 0.05).

RESULTS

Of the 187 participants randomized (1:1 ratio), 34 withdrew or were excluded (protocol deviations or poor cooperation). There were 77 patients in the 0.018-inch slot group and 76 patients in the 0.022-inch slot group (overall mean age: 19.1 years). Baseline characteristics were similar between groups (P > 0.05). The mean duration of treatment for the 0.018-inch and 0.022-inch slot groups was 29.3 and 31.2 months, respectively. There were no statistically significant differences between the two treatment groups in terms of treatment duration, duration of the key stages of treatment, and number of appointments (P > 0.05). The regression analysis revealed 33.0 per cent of variance in treatment duration was explained by age at bonding, Class II division 2 malocclusion, number of failed appointments, number of emergency appointments, and transfer to another clinician. There were no adverse events.

LIMITATIONS

It was impossible to blind clinicians or patients to allocation and oral hygiene and periodontal outcomes were not assessed.

CONCLUSIONS

There was no statistically or clinically significant difference in treatment duration between 0.018-inch and 0.022-inch slot bracket systems. Increasing patient age, Class II division 2 malocclusion, number of failed and emergency appointments, and multi-operator treatment all increase orthodontic treatment duration.

REGISTRATION

The trial was registered with ClinicalTrials.gov on 5 March 2014, registration number: NCT02080338.

PROTOCOL

The protocol was published at DOI: 10.1186/1745-6215-15-389.

摘要

目的

比较0.018英寸和0.022英寸槽沟系统的治疗时长，并确定影响治疗时长的因素。

受试者与方法

年龄在12岁及以上的符合条件的参与者，通过按10人一组进行区组随机化，被分配至0.018英寸或0.022英寸槽沟的MBT矫治器组（3M-Unitek，美国加利福尼亚州蒙罗维亚）。观察指标包括：1. 总体治疗时长；2. 排齐整平阶段时长；3. 精细调整阶段时长；4. 就诊次数及其他与治疗相关的因素。采用参数检验（独立样本t检验）和非参数检验（卡方检验及Fisher精确检验、Mann-Whitney U检验）评估组间差异。多元线性回归分析确定影响治疗时长的因素（P<0.05）。

结果

在187名随机分组（1:1比例）的参与者中，34人退出或被排除（方案偏离或合作不佳）。0.018英寸槽沟组有77例患者，0.022英寸槽沟组有76例患者（总体平均年龄：19.1岁）。两组间基线特征相似（P>0.05）。0.018英寸和0.022英寸槽沟组的平均治疗时长分别为29.3个月和31.2个月。两个治疗组在治疗时长、治疗关键阶段时长及就诊次数方面无统计学显著差异（P>0.05）。回归分析显示，粘结时年龄、安氏II类2分类错牙合、未成功就诊次数、急诊就诊次数以及转诊至另一位临床医生可解释治疗时长变异的33.0%。未发生不良事件。