CLINICAL EFFECTIVENESS OF LATE MAXILLARY PROTRACTION FOR CLEFT LIP AND PALATE

上颌晚期前移治疗唇腭裂的临床疗效

• 批准号: 8889508
• 负责人: Stephen L-K Yen
• 金额: $ 69.13万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8889508
• 关键词: Address; Adolescence; Adolescent; Aftercare; Age; Analysis of Covariance; Appearance; Applications Grants; Benefits and Risks; Bite; Caring; Class III malocclusion; Cleaved cell; Clinical effectiveness; Cohort Studies; Congenital Abnormality; Cost Effectiveness Analysis; Costs and Benefits; Data; Decision Trees; Early treatment; Effectiveness; Esthetics; Face; Future; Grant; Growth; Health Benefit; Hospitals; Lip structure; Malocclusion; Mandible; Maxilla; Measurement; Measures; Medical; Modeling; Morbidity - disease rate; Multicenter Trials; Operative Surgical Procedures; Outcome; Palate; Patients; Pilot Projects; Procedures; Productivity; Public Health; Quality of life; Randomized; Records; Retreatment; Severities; Staging; Surgical sutures; Techniques; Testing; Time; Variant; Visit; base; cleft lip and palate; clinical decision-making; cohort; comparative efficacy; compare effectiveness; cost; cost effectiveness; economic impact; improved; orthognathic; prospective; public health relevance; randomized trial; response; skeletal; standard of care; treatment duration; willingness

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.

描述（由申请人提供）：唇裂和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 类错牙合或骨骼性反颌。 LeFort 1 上颌前移是目前的护理标准，用于在青春期生长完成后矫正反颌，但这是患者将接受的最困难和最昂贵的手术。该赠款提议在一项非随机前瞻性队列研究中将当前的护理标准与非手术方法（上颌前伸）进行比较。这两个队列代表在两个不同年龄进行的治疗，用于矫正患有唇裂和腭裂的青少年的 Cl III 错牙合。 早期治疗，即上颌前移，从 13 岁开始，此时进行，因为上颌缝线尚未融合，易于操作。晚期治疗是在 17 岁时进行正颌手术，此时上颌骨缝已融合且青春期生长已完成。该项目解决的问题是：牵引能否纠正咬合不正并消除或减少治疗晚期的手术需求？我们最初打算开展一项随机试验，首先研究了 287 名患者在手术和延长治疗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。这笔赠款将支持一项两中心队列研究，该研究利用治疗前后收集的记录和数据来比较手术和延长治疗的结果。这是第一个将非手术治疗与当前手术护理标准的有效性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。将使用协方差分析来测量和评估潜在的混杂因素。该研究对公共健康的好处是：1）为骨骼反颌治疗提供非手术和非侵入性的替代治疗方案，同时不取消手术选择；2）降低与唇裂和腭裂相关的护理成本。