MULTISITE CLINICAL TRIAL OF RIGID- VS. WIRE-FIXATION

RIGID 与 RIGID 的多站点临床试验

• 批准号: 3223412
• 负责人: JOHN D RUGH
• 金额: $ 25.75万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-07-01 至 1995-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3223412
• 关键词: clinical trials; dental prosthesis; disease /disorder proneness /risk; fracture fixation; gender difference; human age group; human subject; human therapy evaluation; malocclusion; mandible /maxilla; mastication; metal dental material; oral pharyngeal surgery; orthodontics; orthotics; psychological stressor; temporomandibular joint

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.

在过去的25年里，在纠正 通过外科手术和矫正术的结合来治疗牙面畸形。 这些干预措施已变得相对普遍;然而， 关于各种程序的争议。目前的知识是基于 主要基于病例报告和回顾性比较。有 没有大型随机临床试验来确定疗效， 风险因素，也不确定具体的成本效益 程序.本研究的目的是比较疗效和 两种最常用的手术稳定的成本效益 手术-刚性固定和钢丝固定-在最常见的 正颌手术下颌前移第二个目标是 识别患者风险因素并描述相关并发症 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， 位于盖恩斯维尔的佛罗里达大学。180名患者 牙科医生推荐进行II类牙面矫正手术 malrelation将被随机分配接受刚性或金属丝 固定两组患者将在手术前和手术后进行评估。 在两年的随访期内，术后间隔5次。评估 将由稳定性、口腔功能、感觉神经丧失、TM体征和 症状、生活质量、患者满意度和成本效益。 这些结果评估将由评估人员完成并评分， 对治疗视而不见具体假设将在 使用标准化评估将使我们能够描述 对比病人手术前后的情况审判将有 检测临床显著性的统计功效大于0.90 两个程序之间的差异。审判包括以下规则 停止和中期分析。试验审查和安全委员会将 在计划的五年研究期间，每年评估进展情况。的 从这项临床试验中获得的知识将使临床医生能够 适当地告知患者关于相对疗效，并发症， 和成本效益。结果 还将提供必要的知识，以确定患者的风险， 任何一种手术技术的并发症。长期目标是 改善口腔健康护理和患有 牙面畸形