Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, Brazil.
Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, Brazil.
Am J Orthod Dentofacial Orthop. 2021 Jan;159(1):10-20. doi: 10.1016/j.ajodo.2020.06.031. Epub 2020 Nov 18.
This single-center 2-arm parallel randomized clinical trial aimed to compare the dentoskeletal effects of bonded spurs combined with posterior build-ups vs conventional bonded spurs in the treatment of anterior open bite malocclusion in the mixed dentition.
Patients aged from 7 to 11 years with anterior open bite, recruited at a university orthodontic clinic, were randomly allocated into 2 groups. The experimental group consisted of patients treated with bonded spurs combined with posterior build-ups. The comparison group comprised patients treated with conventional bonded spurs. Lateral headfilms were obtained at pretreatment and after 12 months of treatment. The primary outcome was the change in the overbite. Randomization was performed using the Web site www.randomization.com. Sequentially numbered opaque and sealed envelopes were used for allocation concealment. Blinding was applicable for outcome assessment only. Intergroup comparisons were performed using t or Mann-Whitney U tests (P <0.05). Mean difference (MD) and 95% confidence interval (CI) were obtained.
The experimental group included 24 patients (17 female, 7 male; mean age, 8.22 ± 1.06 years) and the comparison group comprised 25 patients (14 female, 11 male; mean age, 8.30 ± 0.99 years). Baseline demographic and cephalometric characteristics were similar between groups. After 12 months, all patients showed improvements. Both groups showed similar improvements of the overbite (MD, 0.00 mm; 95% CI, -0.92 to 0.91), similar slight decreases of the gonial (MD, 0.02°; 95% CI, -1.11 to 1.15) and mandibular plane (MD, 0.15°; 95% CI, -0.64 to 0.93) angles, and similar mandibular molar extrusion (MD, 0.14 mm; 95% CI, -0.27 to 0.56). The experimental group showed significantly smaller extrusion of the maxillary first molar than the comparison group (MD, -0.70 mm; 95% CI, -0.92 to -0.49). The other dentoskeletal variables showed similar changes without statistically significant intergroup differences. No serious harm was observed other than plaque accumulation around the spurs.
Similar overbite increases and dentoskeletal changes were observed in both groups after 12 months of treatment. Although the experimental group showed significantly smaller extrusion of the maxillary molars, no greater counterclockwise rotation of the mandible than the comparison group was observed.
This trial was registered at Clinicaltrials.gov (Identifier NCT03702881).
The protocol was not published.
This trial was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES), Finance Code 001; and by grants: no. 2017/06440-3, no. 2018/05238-9 and no. 2018/24003-2, São Paulo Research Foundation (FAPESP).
本单中心、2 臂平行随机临床试验旨在比较粘结支抗结合后牙加高与传统粘结支抗在前牙开合混合牙列中的治疗效果。
在大学正畸诊所招募年龄在 7 至 11 岁之间存在前牙开合的患者，并将其随机分为 2 组。实验组由接受粘结支抗结合后牙加高治疗的患者组成。对照组由接受传统粘结支抗治疗的患者组成。在治疗前和治疗后 12 个月拍摄侧位头颅侧位片。主要结局为覆牙合的变化。使用网站 www.randomization.com 进行随机分组。使用连续编号的不透明密封信封进行分组隐藏。仅对结果评估进行盲法。使用 t 检验或曼-惠特尼 U 检验（P<0.05）进行组间比较。获得均值差（MD）和 95%置信区间（CI）。
实验组包括 24 名患者（17 名女性，7 名男性；平均年龄 8.22±1.06 岁），对照组包括 25 名患者（14 名女性，11 名男性；平均年龄 8.30±0.99 岁）。两组患者的基线人口统计学和头影测量特征相似。治疗 12 个月后，所有患者均有改善。两组患者的覆牙合均有类似的改善（MD，0.00mm；95%CI，-0.92 至 0.91），下颌角（MD，0.02°；95%CI，-1.11 至 1.15）和下颌平面（MD，0.15°；95%CI，-0.64 至 0.93）均有类似的轻微减小，下颌磨牙均有类似的外展（MD，0.14mm；95%CI，-0.27 至 0.56）。实验组上颌第一磨牙的外展明显小于对照组（MD，-0.70mm；95%CI，-0.92 至 -0.49）。其他牙颌骨骼变量也有类似的变化，但组间无统计学差异。除支抗周围菌斑堆积外，未观察到其他严重危害。
两组患者在治疗 12 个月后均有相似的覆牙合增加和牙颌骨骼变化。虽然实验组上颌磨牙的外展明显较小，但与对照组相比，下颌没有出现更大的逆时针旋转。
本试验在 Clinicaltrials.gov 注册（标识符 NCT03702881）。
方案未发表。
本试验部分由巴西高等教育人员协调委员会（CAPES）、资金代码 001 资助；并由以下资助：第 2017/06440-3 号、第 2018/05238-9 号和第 2018/24003-2 号项目资助。
