'Multicenter Trial of CPE for Maxillofacial Prosthetics'

描述(申请人提供)：颌面部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部分面部的患者提供临床康复治疗。这是一个孤立的领域，a)为可能耗尽了个人或第三方资金的患者提供根本的康复和生活质量的改善，b)治疗的患者太少，这使得该领域的制造商无利可图，c)为本质上的医疗问题提供了一种牙科解决方案。硅橡胶材料用于面部康复已有40多年的历史，但几乎没有什么改进。显然，需要新的、可替代的、更经济的口腔外颌面修复材料。首席调查员和其他人在20世纪70年代和80年代在新奥尔良海湾南研究所进行的研究开发了一种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)和物理(有效性)要求。与传统但昂贵的硅橡胶产品相比，当时的一项有限的临床试验产生了模棱两可的结果。本研究将进行随机、单交叉、双盲的III期临床试验，以评估a)实验性热塑性CPE和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性。这两个假体都将用皮肤粘合剂附着。在临床试验中，患者丢失的解剖结构将被雕刻，并制作一个石膏模具。硅胶和CPE假体将按随机顺序制造并交付给德克萨斯大学休斯顿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(总共100名)，每人佩戴4个月。详细的问卷将由造型师/实验室技术员、临床医生、佩戴假体前后的医生和患者填写。每个假体佩戴前后的生活质量将用多伦多颅面假体结果测量进行测试。这些方法旨在测试未来的材料和技术。确定需要100名患者的力量分析使用了来自前一项研究数据的非劣势方法。拟议的临床试验的最终分析还将测试CPE(试验性)与硅橡胶(对照)相比是否具有非劣性。结果将决定这种新材料是否在重要特性上至少与传统硅胶相当。寿命将通过跟踪患者来估计。材料特性、成本和加工特性将影响服务不足地区或发展中国家的使用。

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.