CLINICAL EFFECTIVENESS OF LATE MAXILLARY PROTRACTION FOR CLEFT LIP AND PALATE

描述（由申请人提供）：唇腭裂是最常见的面部出生缺陷。与唇腭裂治疗相关的最困难的问题之一是III类错牙合或骨骼反牙合。LeFort 1上颌骨前移是目前的标准治疗方法，用于在青春期发育完成后矫正下咬合，但这是患者将接受的最困难和最昂贵的手术。本基金拟在一项非随机前瞻性队列研究中，将当前标准治疗与非手术方法上颌前牵引进行比较。这两个队列代表了在两个不同年龄段给予的治疗，用于矫正唇腭裂青少年的Cl III错牙合。 早期的治疗，上颌前牵引，开始于13岁，在这个时候，因为上颌缝尚未融合，适合操作。晚期治疗在17岁时进行，当上颌骨缝已经融合并且青春期发育完成时进行正颌手术。这个项目解决的问题是：前牵引是否可以纠正错牙合畸形，并消除或减少后期治疗年龄的手术需求？我们最初打算开展一项随机试验，首先研究了287例患者在手术和延长术之间随机选择治疗的意愿。这项研究表明，涉及面部手术的随机治疗不会被青少年患者接受。这笔拨款将支持一项双中心队列研究，该研究使用治疗前后收集的记录和数据来比较手术和前牵引的结果。这是第一个比较非手术治疗与当前手术治疗标准的有效性的多中心试验，并将为未来关于这些治疗的临床和成本效益的临床决策提供证据。将使用协方差分析测量和评估潜在混杂因素。该研究的公共卫生益处是：1）提供非手术和非侵入性的替代治疗方法，以治疗骨骼下咬，而不会取消手术选择; 2）降低与唇腭裂相关的护理成本。

DESCRIPTION (provided by applicant): Cleft lip and palate is the most commons facial birth defect. One of the most difficult problems associated with cleft treatment is the Class III malocclusion or skeletal underbite. LeFort 1 maxillary advancement is the current standard of care, and is used to correct the underbite after pubertal growth is complete but it is the most difficult and most expensive surgery the patient will undergo. This grant proposes to compare the current standard of care to a non-surgical approach, maxillary protraction in a non-randomized prospective cohort study. The two cohorts represent treatments that are given at two different ages for correcting the Cl III malocclusion in adolescents with cleft lip and palate. The early treatment, maxillary protraction, starts at age 13, is given at this time because the maxillary sutures have not fused yet and are amenable to manipulation. The late treatment, given at age 17, is orthognathic surgery when the maxillary sutures have fused and when adolescent growth is complete. This project addresses the question: Can protraction correct the malocclusion and eliminate or reduce the need for surgery in the late treatment ages? We originally set out to develop a randomized trial, and first studied the willingness of the patientsto randomize their treatment between surgery and protraction in 287 patients. This study showed that randomization of treatment involving facial surgery will not be accepted by teenage patients. This grant will support a two- center cohort study that compares surgery and protraction outcomes using records and data collected before and after treatment. It is the first multicenter trial to compare the effectiveness of non-surgical treatment against the current surgical standard of care and will provide evidence for making clinical decisions in the future regarding clinical and cost effectiveness of these treatments. Potential confounders will be measured and assessed using analysis of covariance. The public health benefits of the study are 1) to provide non-surgical and non-invasive alternatives to treatment for the skeletal underbite without taking away surgical options and 2) to reduce the cost of care associated with cleft lip and palate.