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与 Invisalign 和传统托槽相关的不适:一项随机、前瞻性试验。

Discomfort associated with Invisalign and traditional brackets: A randomized, prospective trial.

出版信息

Angle Orthod. 2017 Nov;87(6):801-808. doi: 10.2319/091416-687.1. Epub 2017 Jul 28.

Abstract

OBJECTIVE

To evaluate differences in discomfort levels between patients treated with aligners and traditional fixed orthodontic appliances.

MATERIALS AND METHODS

This blinded, prospective, randomized equivalence two-arm parallel trial allocated 41 adult Class I nonextraction patients to either traditional fixed appliance (6 males and 12 females) or aligner (11 males and 12 females) treatment. Patients completed daily discomfort diaries following their initial treatment appointment, after 1 month and after 2 months. They recorded their levels of discomfort at rest, while chewing, and while biting, as well as their analgesic consumption and sleep disturbances.

RESULTS

Both treatment modalities demonstrated similar levels of initial discomfort. There were no significant sex differences. Patients in the traditional fixed appliances group reported significantly (P < .05) greater discomfort than patients in the aligner group during the first week of active treatment. There was significantly more discomfort while chewing than when at rest. Traditional patients also reported significantly more discomfort than aligner patients after the first and second monthly adjustment appointments. Discomfort after the subsequent adjustments was consistently lower than after the initial bonding or aligner delivery appointments. A higher percentage of patients in the fixed-appliance group reported taking analgesics during the first week for dental pain, but only the difference on day 2 was statistically significant.

CONCLUSIONS

Patients treated with traditional fixed appliances reported greater discomfort and consumed more analgesics than patients treated with aligners. This trial was not registered.

摘要

目的

评估使用矫正器和传统固定正畸矫治器的患者在不适水平上的差异。

材料和方法

这是一项盲法、前瞻性、随机等效性双臂平行试验,将 41 名成年 I 类非拔牙患者随机分为传统固定矫治器(6 名男性和 12 名女性)或矫正器(11 名男性和 12 名女性)治疗组。患者在初始治疗预约后、1 个月和 2 个月后完成每日不适日记。他们记录了休息时、咀嚼时和咬合时的不适程度,以及他们的镇痛药消耗和睡眠干扰情况。

结果

两种治疗方式在初始不适水平上均表现出相似的水平。性别差异无统计学意义。在主动治疗的第一周,传统固定矫治器组的患者报告的不适程度明显(P<0.05)高于矫正器组的患者。咀嚼时的不适程度明显高于休息时。第一次和第二次每月调整预约后,传统患者报告的不适程度也明显高于矫正器患者。随后调整后的不适程度始终低于初始粘结或矫正器交付预约后的不适程度。在第一周因牙齿疼痛而服用镇痛药的固定矫治器组患者比例较高,但只有第 2 天的差异具有统计学意义。

结论

与使用矫正器治疗的患者相比,使用传统固定矫治器治疗的患者报告的不适程度更大,并且使用的镇痛药更多。本试验未注册。

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