Elkordy Sherif A, Fayed Mona M Salah, Abouelezz Amr M, Attia Khaled H
Associate lecturer, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt.
Associate professor, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt.
Am J Orthod Dentofacial Orthop. 2015 Nov;148(5):755-64. doi: 10.1016/j.ajodo.2015.06.015.
The objective of this 2-arm parallel randomized controlled trial was to evaluate patient acceptance of the mini-implant anchored Forsus Fatigue Resistant Device (FFRD) (3M Unitek, Monrovia, Calif).
The study included 32 skeletal Class II girls. The eligibility criteria included a deficient mandible, a horizontal or neutral growth pattern, an increased overjet, and a full set of erupted permanent teeth. After the leveling and alignment stage, FFRDs and mini-implants were inserted; they were removed after the teeth reached an edge-to-edge incisor relationship. The patients were afterward asked to fill out assessment questionnaires regarding their experience with the FFRD.
The primary outcome of this study was to assess patient acceptance of the appliance and satisfaction with the results. The secondary outcomes were interference with functional activities, noticeability by others, pain, swelling, gum problems caused by the appliance, and appliance breakage.
Computer random sequence generation was done using block sizes of 6 and 4. Allocation concealment was achieved with sequentially numbered opaque sealed envelopes.
Blinding of the clinicians and the patients to the intervention was impossible, but it was done for the outcome assessment and the statistician.
The 32 patients were randomly allocated in a 1:1 ratio into 2 groups: 16 patients (mean age, 13.25 ± 1.12 years) received the FFRD alone (FFRD group), and 16 patients (mean age, 13.07 ± 1.41 years) had mini-implants in conjunction with FFRDs (FMI group). No statistically significant differences were reported between the 2 groups regarding ease of appliance insertion, noticeability by others, pain, swelling, effects on eating and speech, and gum bleeding; 100% and 87.5% were satisfied with the results in the FFRD and FMI groups, respectively, with a ridit value of 0.57 (95% confidence interval, 0.43-0.71; P = 0.36). No serious harm was observed other than swelling of the cheeks, which occurred in 4 patients.
There were no significant differences between the patients' acceptance of the FFRD and the mini-implant anchored FFRD. They were highly satisfied with the results. Neither group reported significant functional limitations.
This trial was not registered.
The protocol was not published before trial commencement.
The study was self-funded by the authors.
这项双臂平行随机对照试验的目的是评估患者对微型种植体锚固的 Forsus 抗疲劳装置（FFRD）（3M Unitek，蒙罗维亚，加利福尼亚州）的接受程度。
该研究纳入了 32 名骨骼 II 类女童。入选标准包括下颌骨发育不足、水平或中性生长模式、覆盖增加以及全套恒牙萌出。在整平排齐阶段后，插入 FFRD 和微型种植体；当牙齿达到切缘对切缘关系后将其取出。之后要求患者填写关于他们使用 FFRD 体验的评估问卷。
本研究的主要结果是评估患者对该矫治器的接受程度以及对结果的满意度。次要结果包括对功能活动的干扰、他人的注意程度、疼痛、肿胀、矫治器引起的牙龈问题以及矫治器损坏情况。
使用 6 和 4 的区组大小进行计算机随机序列生成。通过顺序编号的不透明密封信封实现分配隐藏。
临床医生和患者对干预措施无法设盲，但对结果评估人员和统计人员设盲。
32 名患者按 1:1 比例随机分为两组：16 名患者（平均年龄，13.25±1.12 岁）仅接受 FFRD（FFRD 组），16 名患者（平均年龄，13.07±1.41 岁）使用微型种植体联合 FFRD（FMI 组）。两组在矫治器插入的难易程度、他人的注意程度、疼痛、肿胀、对进食和言语的影响以及牙龈出血方面未报告有统计学显著差异；FFRD 组和 FMI 组分别有 100%和 87.5%对结果满意，ridit 值为 0.57（95%置信区间，0.43 - 0.71；P = 0.36）。除了 4 名患者出现脸颊肿胀外，未观察到其他严重危害。
患者对 FFRD 和微型种植体锚固的 FFRD 的接受程度无显著差异。他们对结果高度满意。两组均未报告有显著的功能限制。
该试验未注册。
方案在试验开始前未发表。
该研究由作者自筹资金。
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