CLINICAL EFFECTIVENESS OF LATE MAXILLARY PROTRACTION FOR CLEFT LIP AND PALATE

简介(申请人提供)：唇腭裂是最常见的面部出生缺陷。与唇裂治疗相关的最困难的问题之一是III类错牙合或骨骼下牙合。Lefort 1上颌前移是目前的护理标准，用于青春期发育完成后矫正下牙合，但这是患者将接受的最困难和最昂贵的手术。这项拨款建议在一项非随机前瞻性队列研究中，将目前的护理标准与非手术方法上颌骨前牵引进行比较。这两个队列代表了在两个不同的年龄段为矫正唇腭裂青少年的ClIII错牙合而进行的治疗。 早期的治疗，上颌骨前牵引，从13岁开始，在这个时候进行，因为上颌缝还没有融合，而且易于操作。晚期治疗在17岁时进行，当上颌骨缝合融合和青春期发育完成时，进行正颌手术。这个项目解决的问题是：延长牵引能否纠正错牙合，消除或减少晚期治疗年龄的手术需求？我们最初打算开发一项随机试验，首先研究了287名患者在手术和延长治疗之间随机治疗的意愿。这项研究表明，青少年患者不会接受涉及面部手术的随机治疗。这笔赠款将支持一项双中心队列研究，该研究使用治疗前和治疗后收集的记录和数据来比较手术和延长的结果。这是第一次将非手术治疗的有效性与目前的外科治疗标准进行比较的多中心试验，并将为未来就这些治疗的临床和成本效益做出临床决策提供证据。潜在的混杂因素将使用协方差分析进行测量和评估。这项研究对公众健康的好处是：1)在不剥夺手术选择的情况下，为骨骼下牙合的治疗提供非手术和非侵入性的替代选择；2)减少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.