Egli Fabienne, Bovali Efstathia, Kiliaridis Stavros, Cornelis Marie A
Division of Orthodontics, School of Dentistry, University of Geneva, Geneva, Switzerland.
Private practice, Thiva, Greece.
Am J Orthod Dentofacial Orthop. 2017 Jan;151(1):15-27. doi: 10.1016/j.ajodo.2016.09.009.
The objectives of this 2-arm parallel trial were to compare the numbers of failures of mandibular fixed retainers bonded with indirect and direct methods and to investigate the posttreatment changes 2 years after placement.
Sixty-four consecutive patients from the postgraduate orthodontic clinic of the University of Geneva in Switzerland were randomly allocated to either an indirect or a traditional direct bonding procedure of a mandibular fixed retainer at the end of their orthodontic treatment (T0). Eligibility criteria were the presence of the 4 mandibular incisors and the 2 mandibular canines, and no active caries, restorations, fractures, or periodontal disease of these teeth. The patients were randomized in blocks of 4 (using an online randomization service) with allocation concealment secured by contacting the sequence generator for assignment. The patients were recalled 12 months and 24 months (T3) after retainer bonding. The main outcome was any first-time failure of retainers (ie, at least 1 composite pad debonded or fractured); unexpected posttreatment changes of the mandibular incisors and canines were a secondary outcome. Impressions and lateral cephalograms were taken at T0 and T3: changes in mandibular intercanine and interpremolar distances and mandibular incisor inclination were assessed. Blinding was applicable for outcome assessment only. The chi-square test and Cox regression were used to compare the survival rates of the retainers bonded with direct and indirect methods. Paired t tests were used to assess differences in intercanine and interpremolar distances and mandibular incisor inclination at T0 and T3. Significance was set at P <0.05.
Sixty-four patients were randomized in a 1:1 ratio. One patient dropped out at baseline, and 3 patients did not reach the T3 recall. In 24 of 60 (40%) patients, the fixed retainer failed within 2 years: 13 of 30 (43%) in the indirect bonding group and 11 of 30 (37%) in the direct bonding group (log-rank test, P = 0.64). The hazard ratio was 1.26 (95% confidence interval, 0.56-2.81; P = 0.58). Bond failures occurred mainly during the first year. There were no clinically significant changes in mandibular intercanine distance, interpremolar distance, and incisor inclination between T0 and T3, or between groups. In 5 patients (17%), all in the direct bonding group, unexpected posttreatment changes, systematically consisting in a lingual inclination of the mandibular left canine, were observed. In 1 patient (3%), the change was considered clinically severe. No other serious harm was observed.
There was no difference in the risks of failure between mandibular retainers bonded with direct and indirect methods. Bonded retainers are effective in maintaining intercanine and interpremolar distances. There seem to be fewer unexpected posttreatment changes with retainers bonded with the indirect compared with the direct method.
The trial was not registered.
The protocol was not published before trial commencement.
No funding or conflict of interest to be declared.
这项双臂平行试验的目的是比较采用间接法和直接法粘结的下颌固定保持器的失败数量,并研究放置后2年的治疗后变化。
来自瑞士日内瓦大学正畸研究生诊所的64例连续患者在正畸治疗结束时(T0)被随机分配接受下颌固定保持器的间接粘结或传统直接粘结程序。纳入标准为存在4颗下颌切牙和2颗下颌尖牙,且这些牙齿无活动性龋病、修复体、骨折或牙周疾病。患者以4例为一组进行随机分组(使用在线随机服务),通过联系序列生成器进行分配以确保分配隐藏。在保持器粘结后12个月和24个月(T3)对患者进行回访。主要结局是保持器的任何首次失败(即至少1个复合垫脱粘或断裂);下颌切牙和尖牙的意外治疗后变化为次要结局。在T0和T3时采集印模和头颅侧位片:评估下颌尖牙间和前磨牙间距离以及下颌切牙倾斜度的变化。仅对结局评估采用盲法。采用卡方检验和Cox回归比较直接法和间接法粘结的保持器的生存率。采用配对t检验评估T0和T3时尖牙间和前磨牙间距离以及下颌切牙倾斜度的差异。显著性设定为P<0.05。
64例患者按1:1比例随机分组。1例患者在基线时退出,3例患者未达到T3回访。在60例患者中的24例(40%)中,固定保持器在2年内失败:间接粘结组30例中的13例(43%),直接粘结组30例中的11例(37%)(对数秩检验,P=0.64)。风险比为1.26(95%置信区间,0.56 - 2.81;P=0.58)。粘结失败主要发生在第一年。在T0和T3之间,或两组之间,下颌尖牙间距离、前磨牙间距离和切牙倾斜度均无临床显著变化。在5例患者(17%)中,均在直接粘结组,观察到意外的治疗后变化,均表现为下颌左尖牙舌向倾斜。在1例患者(3%)中,该变化被认为临床严重。未观察到其他严重损害。
采用直接法和间接法粘结的下颌保持器的失败风险无差异。粘结保持器在维持尖牙间和前磨牙间距离方面有效。与直接法相比,间接法粘结的保持器似乎出现的意外治疗后变化更少。
该试验未注册。
方案在试验开始前未发表。
无需声明资金或利益冲突。