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首页> 外文期刊>American Journal of Orthodontics and Dentofacial Orthopedics >Dentoskeletal outcomes of a rapid maxillary expander with differential opening in patients with bilateral cleft lip and palate: A prospective clinical trial
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Dentoskeletal outcomes of a rapid maxillary expander with differential opening in patients with bilateral cleft lip and palate: A prospective clinical trial

机译：双侧唇left裂患者快速上颌扩张器不同开口的牙骨结局：一项前瞻性临床试验

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Introduction: The purpose of this 2-arm parallel study was to evaluate the dentoskeletal effects of rapid maxillary expansion with differential opening (EDO) compared with the hyrax expander in patients with complete bilateral cleft lip and palate. Methods: A sample of patients with complete bilateral cleft lip and palate was prospectively and consecutively recruited. Eligibility criteria included participants in the mixed dentition with lip and palate repair performed during early childhood and maxillary arch constriction with a need for maxillary expansion before the alveolar bone graft procedure. The participants were consecutively divided into 2 study groups. The experimental and control groups comprised patients treated with rapid maxillary expansion using EDO and the hyrax expander, respectively. Cone-beam computed tomography examinations and digital dental models of the maxillary dental arches were obtained before expansion and 6 months postexpansion. Standardized cone-beam computed tomography coronal sections were used for measuring maxillary transverse dimensions and posterior tooth inclinations. Digital dental models were used for assessing maxillary dental arch widths, arch perimeters, arch lengths, palatal depths, and posterior tooth inclinations. Blinding was used only during outcome assessment. The chi-square test was used to compare the sex ratios between groups (P < 0.05). Intergroup comparisons were performed using independent t tests with the Bonferroni correction for multiple tests. Results: Fifty patients were recruited and analyzed in their respective groups. The experimental group comprised 25 patients (mean age, 8.8 years), and the control group comprised 25 patients (mean age, 8.6 years). No intergroup significant differences were found for age, sex ratio, and dentoskeletal variables before expansion. No significant differences were found between the EDO and the hyrax expander groups regarding skeletal changes. The EDO promoted significantly greater increases of intercanine width (difference, 3.63 mm) and smaller increases in canine buccal tipping than the conventional hyrax expander. No serious harm was observed other than transitory variable pressure sensations on the maxillary alveolar process in both groups. Conclusions: The EDO produced skeletal changes similar to the conventional hyrax expander. The differential expander is an adequate alternative to conventional rapid maxillary expanders when there is need for greater expansion in the maxillary dental arch anterior region. Registration: This trial was not registered. Protocol: The protocol was not published before trial commencement. Funding: This study received financial support from FAPESP (process number 2009/17622-9). As a possible conflict of interest, a patent with an EDO was submitted in March 2011 to the National Institute of Industry Property and is still in process. However, we believe that this is a natural step of translational research (bench-to-bedside), and we guarantee that the scientific results are true.
机译：简介：这项2臂平行研究的目的是评估在完全双侧唇裂和bilateral裂患者中，上颌骨快速扩张带差异开口（EDO）与蹄兔扩张器的牙本质骨骼作用。方法：前瞻性和连续性收集双侧唇left裂完全的患者样本。资格标准包括在儿童早期进行的上颚和唇lip骨混合修复的参与者以及上颌牙弓狭窄，需要在牙槽骨移植手术之前进行上颌骨扩张。参与者被连续分为2个研究组。实验组和对照组分别使用EDO和非洲蹄兔扩张器进行快速上颌扩张治疗。在扩张前和扩张后6个月获得了上颌牙弓的锥形束计算机断层扫描检查和数字化牙齿模型。标准化的锥形束计算机断层扫描冠状断面用于测量上颌骨横向尺寸和后牙倾斜度。数字牙科模型用于评估上颌牙弓的宽度，弓的周长，弓的长度，pa深度和后牙倾斜度。盲法仅在结果评估期间使用。卡方检验用于比较各组之间的性别比（P <0.05）。组间比较使用独立的t检验和Bonferroni校正进行多次检验。结果：分别招募了50名患者并对其进行了分析。实验组包括25名患者（平均年龄，8.8岁），对照组包括25名患者（平均年龄，8.6岁）。在扩张之前，没有发现年龄，性别比和牙本质骨骼变量的组间显着差异。在EDO和蹄兔扩张剂组之间，在骨骼变化方面没有发现显着差异。与传统的蹄兔扩张器相比，EDO促进了犬间宽度的明显增加（差异为3.63 mm），而犬颊侧倾角的增加较小。除对两组上颌牙槽突有短暂的变压感觉外，未观察到严重伤害。结论：EDO产生的骨骼变化类似于常规的非洲蹄兔扩张器。当需要在上颌牙弓前部区域进行更大的扩张时，差速扩张器是常规快速上颌扩张器的适当替代。注册：该试验尚未注册。方案：该方案在试验开始之前尚未发布。资金：该研究获得了FAPESP的财务支持（流程号2009 / 17622-9）。作为可能的利益冲突，2011年3月，具有EDO的专利已提交给美国国家工业产权局，目前仍在处理中。但是，我们认为这是转化研究（从实验台到实验台）的自然步骤，并且我们保证科学结果是正确的。

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