Burhan Ahmad S, Nawaya Fehmieh R
*Orthodontic Department, Faculty of Dentistry, Al-Baath University, Homs,
*Orthodontic Department, Faculty of Dentistry, Al-Baath University, Homs.
Eur J Orthod. 2015 Jun;37(3):330-7. doi: 10.1093/ejo/cju052. Epub 2014 Oct 8.
The current parallel group, randomized controlled trial aimed to compare the dentoalveolar and skeletal changes resulting from treatment using two popular functional appliances: the Bite-Jumping Appliance (BJA) and the Twin-Block Appliance (TBA).
This study is designed as a parallel-group, randomized controlled trial.
Patients were screened from the patients who were seeking treatment at the Department of Orthodontics, Al-Baath University. Eligibility criteria included skeletal Class II division 1 malocclusion resulting from the retrusion of the mandible. A computer-generated randomization list was used to randomly divide the patients into two equal groups to be treated with either the BJA or the TBA. Blinding was applicable for outcome assessment only. Forty-four patients (22 male and 22 female) aged 10.2-13.5 years were randomized in a 1:1 ratio to either the BJA or the TBA groups, and four patients were lost to follow-up (two from each group). Lateral cephalometric radiographs were obtained before treatment and after 12 months of active appliance therapy. Inter-group differences were evaluated with two-sample t-tests, and intra-group differences were assessed with paired-sample t-tests at the P <0.05 level.
Forty patients (20 in each group) were available for the statistical analysis. Baseline characteristics were similar between groups. Similar changes were observed in the sagittal plane, including a significant increase in the SNB angle. No significant changes were observed in the maxilla. The lower incisors were significantly proclined, and the upper incisors significantly retruded. In the vertical plane, BJA induced mandibular clockwise rotation, and the SN:MP angle increased by 2.14 ± 2.97° (P = 0.002). Conversely, no significant changes took place in this angle in the TBA group 0.75 ± 2.37° (P = 0.096). Similarly, Jarabak ratio decreased significantly in the BJA group by -1.78 ± 0.85% (P = 0.002) and increased significantly in the TBA group by 1.26 ± 0.76% (P = 0.032), with significant differences between the two groups (P ≤ 0.001). No serious harm was observed.
A limitation of this research is a lack of an untreated control group. However, the resulting differences between the two groups can be attributed to the appliance differences, which fulfil the aim of the current research.
Each of the two appliances is recommended for the functional treatment of skeletal Class II malocclusion resulting from the retrusion of the mandible. The BJA is recommended when clockwise rotation is desired, whereas the TBA is recommended to inhibit vertical development.
This trial was registered at the Department of Orthodontics, Al-Baath University, Number 16, on 6/25/2012.
The protocol was not published before trial commencement.
No funding or conflict of interest to be declared.
当前这项平行组随机对照试验旨在比较使用两种常用功能性矫治器(咬合跳跃矫治器(BJA)和双阻板矫治器(TBA))进行治疗所导致的牙槽骨和骨骼变化。
本研究设计为平行组随机对照试验。
从在巴阿萨大学正畸科寻求治疗的患者中筛选患者。纳入标准包括因下颌后缩导致的骨性安氏II类1分类错牙合。使用计算机生成的随机分组列表将患者随机分为两组,分别用BJA或TBA进行治疗。仅在结果评估时采用盲法。44名年龄在10.2 - 13.5岁的患者(22名男性和22名女性)按1:1比例随机分为BJA组或TBA组,4名患者失访(每组2名)。在治疗前和积极矫治器治疗12个月后拍摄头颅侧位片。组间差异采用两样本t检验进行评估,组内差异采用配对样本t检验在P <0.05水平进行评估。
40名患者(每组20名)可用于统计分析。两组间基线特征相似。在矢状面观察到相似变化,包括SNB角显著增加。上颌未观察到显著变化。下切牙显著前倾,上切牙显著后缩。在垂直面,BJA导致下颌顺时针旋转,SN:MP角增加2.14±2.97°(P = 0.002)。相反,TBA组该角度无显著变化,为0.75±2.37°(P = 0.096)。同样,Jarabak比率在BJA组显著降低,为-1.78±0.85%(P = 0.002),在TBA组显著增加,为1.26±0.76%(P = 0.032),两组间差异显著(P≤0.001)。未观察到严重不良影响。
本研究的一个局限性是缺乏未治疗的对照组。然而,两组间产生的差异可归因于矫治器差异,这符合当前研究的目的。
对于因下颌后缩导致的骨性II类错牙合的功能性治疗,推荐使用这两种矫治器中的任何一种。当希望出现顺时针旋转时推荐使用BJA,而推荐使用TBA来抑制垂直向发育。
本试验于2012年6月25日在巴阿萨大学正畸科注册,注册号为16。
方案在试验开始前未发表。
无需声明资金来源或利益冲突。