CLINICAL EFFECTIVENESS OF LATE MAXILLARY PROTRACTION FOR CLEFT LIP AND PALATE

描述（申请人提供）：唇腭裂是最常见的面部先天性缺陷。与唇裂治疗相关的最困难的问题之一是III类错牙合或骨骼下咬合。LeFort 1上颌前移是目前的标准护理，用于矫正青春期发育完成后的下咬合，但这是患者将接受的最困难和最昂贵的手术。这项拨款旨在比较目前的护理标准和非手术方法，上颌前伸在一项非随机前瞻性队列研究中。这两个队列代表了在两个不同年龄给予矫正唇腭裂青少年cliii型错牙合的治疗。

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.