Multicenter Trial of CPE for Maxillofacial Prosthetics

CPE 用于颌面修复的多中心试验

• 批准号: 6612482
• 负责人: Lawrence M. Gettleman
• 金额: $ 64.84万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-21 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6612482
• 关键词: biomaterial development /preparation; biomaterial evaluation; clinical research; clinical trial phase III; cooperative study; cost effectiveness; human subject; medical implant science; oral facial restoration; oral facial restoration material; oral pharyngeal neoplasm; patient oriented research; plastics; prosthesis; quality of life; questionnaires; silicone rubber; training

DESCRIPTION (provided by applicant): Maxillofacial prosthetics is a subspecialty of prosthodontics, providing the clinical rehabilitation treatment of patients who have lost parts of the face due to cancer, trauma, or birth defects. It is an orphan field, a) offering fundamental rehabilitation and improvement in the quality of life to patients who may have exhausted personal or third party funding, b) treating so few patients that it makes the field unprofitable for manufacturers, and c) provides a dental solution to an essentially medical problem. Silicone rubber materials have been used for facial rehabilitation for more than 4 decades with few improvements. There is a clear need for new, alternative, and more economic materials for extraoral maxillofacial prostheses. Research at Gulf South Research Institute in New Orleans by the Principal Investigator and others in the 1970s and 1980s developed an alternative low-cost thermoplastic material (chlorinated polyethylene, CPE) that met all toxicological (safety) and physical (effectiveness) requirements. A limited clinical trial at the time yielded equivocal results when compared to conventional but costly silicone rubber products. This research will conduct a randomized, single-crossover, double-blinded Phase III clinical trial to evaluate a) experimental thermoplastic CPE, and b) control silicone (Silastic Adhesive A/MDX4-4210) materials for non-inferiority of CPE based on functional & subjective characteristics, and on the quality of life. Both prostheses will be attached with a skin adhesive. In the clinical trial, the patient's missing anatomy will be sculpted and a gypsum mold made. The silicone and the CPE prosthesis will be fabricated and delivered in random order to 50 patients at M.D. Anderson Cancer Center, University of Texas, Houston, 30 patients at Toronto Sunnybrook Regional Cancer Centre, and 20 patients at J.G, Brown Cancer Center, University of Louisville (100 total) to be worn for 4 months each. Detailed questionnaires will be filled out by the anaplastologist/laboratory technician, clinicians, before and after the prostheses are worn, and the patient. Quality-of-life before and after wearing each prosthesis will be tested with the Toronto Outcomes Measure for Craniofacial Prosthetics. These methods were designed to test future materials and techniques. The power analysis that determined that 100 patients would be needed used a non-inferiority approach from data in the previous study. The final analysis of the proposed clinical trial will also test for non-inferiority of CPE (experimental) compared to silicone rubber (control). The outcome will determine if the new material is at least equivalent to conventional silicone in important features. Longevity will be estimated by following patients. Material properties, their cost, and processing characteristics will affect use in underserved areas or developing countries.

描述（由申请人提供）：颌面修复是口腔修复学的一个亚专业，为因癌症、创伤或出生缺陷而失去部分面部的患者提供临床康复治疗。这是一个孤儿领域，a)为可能已经耗尽个人或第三方资金的患者提供基本的康复和改善生活质量，b)治疗的患者太少，使得该领域的制造商无利可图，c)为一个基本的医疗问题提供牙科解决方案。硅橡胶材料已用于面部康复超过40年，几乎没有改进。对于新型的、可替代的、更经济的口腔外颌面修复材料的需求是显而易见的。1970年代和1980年代，新奥尔良南海湾研究所的首席研究员和其他研究人员开发了一种可替代的低成本热塑性材料（氯化聚乙烯，CPE），该材料满足所有毒理学（安全性）和物理（有效性）要求。与传统但昂贵的硅橡胶产品相比，当时有限的临床试验产生了模棱两可的结果。本研究将进行一项随机、单交叉、双盲的III期临床试验，以评估a)实验性热塑性CPE， b)对照硅胶（硅橡胶粘合剂a /MDX4-4210）材料在CPE的功能和主观特征以及生活质量方面的非劣效性。两个假体都将附着皮肤粘合剂。在临床试验中，将对患者缺失的解剖结构进行雕刻，并制作石膏模具。硅胶和CPE假体将按随机顺序制造并交付给休斯顿德克萨斯大学安德森癌症中心的50名患者、多伦多森尼布鲁克地区癌症中心的30名患者和路易斯维尔大学布朗癌症中心的20名患者（共100名），每人佩戴4个月。在假体佩戴前后，整形医生/实验室技术人员、临床医生和患者将填写详细的调查问卷。佩戴每个假体前后的生活质量将用多伦多颅面假体结果测量法进行测试。这些方法旨在测试未来的材料和技术。功率分析确定需要100名患者，使用了先前研究数据的非劣效性方法。拟议临床试验的最终分析还将测试CPE（实验）与硅橡胶（对照）的非劣效性。研究结果将决定这种新材料在重要特征上是否至少与传统硅树脂相当。寿命将通过跟踪患者来估计。材料性能、成本和加工特性将影响在服务不足地区或发展中国家的使用。