'Multicenter Trial of CPE for Maxillofacial Prosthetics'

“用于颌面修复的 CPE 多中心试验”

• 批准号: 6794143
• 负责人: Lawrence M. Gettleman
• 金额: $ 57.4万
• 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/6794143
• 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）：颌面修复学是口腔修复学的一个分支，为因癌症、创伤或出生缺陷而失去面部部分的患者提供临床康复治疗。这是一个孤立的领域，a）为可能耗尽个人或第三方资金的患者提供基本的康复和生活质量的改善，B）治疗的患者如此之少，使得该领域对制造商无利可图，以及c）为本质上的医疗问题提供牙科解决方案。 硅橡胶材料已用于面部修复超过40年，几乎没有改进。有一个明确的需要新的，替代的，更经济的材料，口外颌面假体。20世纪70年代和80年代，新奥尔良海湾南方研究所的主要研究者和其他人开发了一种替代的低成本热塑性材料（氯化聚乙烯，CPE），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III期临床试验，以评价a）实验性热塑性CPE和B）对照硅胶（硅橡胶粘合剂A/MDX 4 -4210）材料基于功能和主观特征以及生活质量的CPE非劣效性。 两个假体都将使用皮肤粘合剂连接。 在临床试验中，患者缺失的解剖结构将被雕刻并制作石膏模具。将制造硅胶和CPE假体，并在M.D.随机交付给50名患者。休斯顿德克萨斯大学安德森癌症中心的30名患者、多伦多桑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。 将由整形外科医生/实验室技术员、临床医生、假体佩戴前后以及患者填写详细的问卷。将使用多伦多颅面修复体结局测量对佩戴每种修复体前后的生活质量进行测试。这些方法旨在测试未来的材料和技术。 确定需要100例患者的把握度分析使用了既往研究数据的非劣效性方法。拟定临床试验的最终分析还将检验CPE（实验）与硅橡胶（对照）相比的非劣效性。结果将确定新材料是否至少在重要特性方面与传统硅胶等同。将通过以下患者估计寿命。材料特性、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。