Private Practice, Limassol, Cyprus.
Department of Dentistry, School of Medicine, European University Cyprus, Nicosia, Cyprus.
Eur J Orthod. 2023 Feb 10;45(1):51-57. doi: 10.1093/ejo/cjac028.
The aim of this trial was to assess the effect of enamel sandblasting in addition to the acid-etch technique in reducing first-time failures of fixed mandibular retainers placed over a 12-month period.
Ethical approval was obtained. Participants were recruited in a single private practice. The primary outcome of this study was any first-time failure of the mandibular fixed retainer assessed at three timepoints over a 12-month period. Three consecutive teeth either on the left or right side (from lower canine-lower central incisor) were randomly allocated to the intervention (sandblasting) and the control (non-sandblasted). Randomization was performed using a centralized randomization service. The patients were randomized in blocks of four and eight with allocation concealment secured by contacting the sequence generator for group assignment. Blinding of either the patient or clinicians was not possible at time of placement of the mandibular retainer.
One hundred and ninety-seven participants were randomized to receive enamel sandblasting (intervention) and non-sandblasting (control) in the region of the six anterior mandibular teeth in a split-mouth fashion. Participants were recruited between December 2018 to October 2020. The data for all participants were analysed resulting in 394 observations. Overall, the risk of first-time failure was 11.4%. No difference in first-time failures was observed between the intervention (sandblasting) and control (non-sandblasting) groups [hazard ratio (HR), 1.05; 95% confidence interval (CI), 0.59, 1.88, P = 0.88]. Males had a higher instant probability of first-time failures (HR, 3.18; 95% CI, 1.65-6.14; P < 0.01). Participants with a fair level of co-operation had a lower instant probability of first-time failures (HR, 0.37; 95% CI, 0.16-0.86; P = 0.02). There were no harms reported to either the participant or their dentition.
No difference in the first-time failures of mandibular bonded retainers placed with conventional etch-bond technique with or without enamel sandblasting was observed. The overall risk of first-time failure was 11.4%.
This trial was not registered prior to trial commencement.
本试验旨在评估在酸蚀技术基础上增加釉质喷砂处理对 12 个月内下颌固定保持器初次失败的影响。
本研究获得伦理批准。参与者在一家私人诊所招募。本研究的主要结局是在 12 个月的 3 个时间点评估下颌固定保持器的任何初次失败。从左侧或右侧的连续 3 颗牙齿（从下尖牙到下中切牙）随机分配到干预组（喷砂）和对照组（未喷砂）。使用集中随机服务进行随机分组。患者按 4 个和 8 个分组进行随机化，分组隐藏通过联系序列生成器进行组分配来保证。在放置下颌保持器时，患者或临床医生均无法被蒙蔽。
197 名参与者被随机分配到 6 颗下颌前牙区域接受釉质喷砂（干预）或非喷砂（对照）处理，采用分口设计。参与者于 2018 年 12 月至 2020 年 10 月间招募。对所有参与者的数据进行了分析，共获得 394 个观察结果。总体而言，初次失败的风险为 11.4%。干预组（喷砂）与对照组（非喷砂）之间初次失败无差异[风险比（HR），1.05；95%置信区间（CI），0.59，1.88，P = 0.88]。男性初次失败的即时概率较高（HR，3.18；95%CI，1.65-6.14；P < 0.01）。合作水平一般的参与者初次失败的即时概率较低（HR，0.37；95%CI，0.16-0.86；P = 0.02）。未报告参与者或其牙列有任何伤害。
未发现常规酸蚀粘结技术结合或不结合釉质喷砂处理下颌粘结保持器初次失败的差异。初次失败的总体风险为 11.4%。
本试验在试验开始前未进行注册。
