MULTISITE CLINICAL TRIAL OF RIGID- VS. WIRE-FIXATION

在过去的25年里，在纠正方面取得了重大进展 通过手术和正畸相结合的方式治疗牙面畸形。 这些干预措施已经变得相对常见；然而，有 关于各种程序的争议。当前的知识是基于 主要是根据病例报告和回顾比较。曾经有过 没有大型随机临床试验来确定疗效，以确定 风险因素，也不能确定具体的成本效益 程序。本研究的目的是比较两种治疗方法的疗效。 两种最常用的手术内固定器的成本-效果分析 手术--坚固固定和钢丝固定--在最常见的 正颌手术--下颌前移。次要目标是 确定患者的风险因素并描述相关的并发症 通过这两个程序。这些目标将通过一个 涉及三个地点的随机临床试验：德克萨斯大学 圣安东尼奥健康科学中心、亚特兰大埃默里大学和 佛罗里达大学盖恩斯维尔分校。180名患者 由正畸医生转介进行II类牙面外科矫正 错位关系将被随机分配以接收刚性或线缆 定格。两组患者将在手术前和手术时进行评估。 在两年的随访期内进行了五次手术后间隔。评估 将由稳定性、口腔功能、神经感觉丧失、TM体征和 症状、生活质量、患者满意度和成本效益。 这些结果评估将由以下评价者完成并评分 对治疗视而不见。具体的假设将在 小组和标准化评估的使用将使我们能够描述 比较我们的病人手术前后的情况。审判将会有 检测临床有意义的统计能力大于0.90 这两个程序之间的差异。该试验包括以下规则 停止和中期分析。一个试验审查和安全委员会将 在计划的五年研究中，每年评估进展情况。这个 从这项临床试验中获得的知识将使临床医生 适当地建议患者关于相对疗效、并发症、 以及这些常见正颌手术的成本效益。结果是 还将提供必要的知识，以确定有风险的患者 任何一种手术技术的并发症。长期目标是 改善口腔保健和老年人的整体生活质量 牙面关系不良。

During the past 25 years significant advances have been made in correcting dentofacial malrelations through a combination of surgery and orthodontics. These interventions have become relatively common; however, there are controversies regarding the various procedures. Current knowledge is based primarily upon case reports and retrospective comparisons. There have been no large randomized clinical trials to establish efficacy, to determine risk factors, nor to establish the cost-effectiveness of specific procedures. The objective of this research is to compare the efficacy and cost-effectiveness of the two most commonly used surgical stabilization procedures--rigid fixation and wire fixation--in the most common orthognathic procedure--mandibular advancement. A secondary objective is to identify patient risk factors and describe the complications associated with these two procedures. These objectives will be accomplished through a randomized clinical trial involving three sites: The University of Texas Health Science Center at San Antonio, Emory University in Atlanta, and the University of Florida at Gainesville. One hundred and eighty patients referred by orthodontists for surgical correction of a Class II dentofacial malrelation will be randomly assigned to receive either rigid or wire fixation. The two patient groups will be assessed before surgery and at five post-surgical intervals over a two-year follow-up period. Assessments will be made of stability, oral function, neurosensory loss, TM signs and symptoms, quality of life, patient satisfaction, and cost-effectiveness. These outcome assessments will be accomplished and scored by evaluators who are blind to the treatment. Specific hypotheses will be tested between groups and the use of standardized assessments will allow us to describe and compare our patients pre- and post-surgery. The trial will have statistical power greater than 0.90 to detect clinically significant differences between the two procedures. The trial includes rules for stopping and interim analyses. A trial review and safety committee will evaluate progress at yearly intervals over the planned five-year study. The knowledge gained from this clinical trial will allow clinicians to appropriately advise patients about the relative efficacy, complications, and cost-effectiveness of these common orthognathic procedures. The results will also provide the necessary knowledge to identify patients at risk for complications with either surgical technique. The long-term objective is to improve oral health care and overall quality of life of persons having dentofacial malrelations.