CLINICAL EVALUATION OF CPE IN MAXILLOFACIAL PROSTHESES

颌面修复体中 CPE 的临床评估

• 批准号: 3219976
• 负责人: Lawrence M. Gettleman
• 金额: $ 9.48万
• 依托单位: GULF SOUTH RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1983
• 资助国家: 美国
• 起止时间: 1983-09-20 至 1987-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3219976
• 关键词: chlorine; congenital disorders; dental adhesive /sealant; elastomers; human subject; oral pharyngeal neoplasm; orthodontic appliances; polyethylenes; polyurethanes; polyvinyls; questionnaires; silicates; skin neoplasms; trauma

Replacement of parts of the human face and jaws with manmade materials is the purview of maxillofacial prosthetics. Patients recovering from the surgical effects of skin cancer, oral cancer, traumatic injuries, and birth defects are in need of these services. Existing materials used for this purpose include silicone, polyurethane, and vinyl elastomers. Devices made of such material often fail in a matter of months due to discoloration, fraying of feather edges, sagging, or incompatibility with adhesives. A development program was carried out in 1976-79 at GSRI by Paul D. May and Luis R. Guerra using chlorinated polyethylene (CPE), an industrial elastomer produced by Dow Chemical Company. Limited clinical trials indicated the material to be satisfactory for a more extended trial. This project will continue this work in four parts: 1. Improve the CPE material from its 1979 level and measure its physical and biologic properties using procedure since-developed for use with soft denture liners. Investigate improved phosphate-bonded, or gypsum molds. 2. Perform a pilot study to measure the reliability and validity of: a) tests of material performance, and b) questionnaires of clinician's observations and the patient's perception of existing maxillofacial prostheses. Use this information to modify the test instrument for the principal clinical study. 3. Provide materials and technology to the Dental Department of the Charity Hospital of New Orleans for clinical trials. Twenty patients needing extraoral maxillofacial prostheses will be selected. Each will receive two prostheses, made from the CPE material or from silicone rubber, to be exchanged every 3 months and worn continuously. 4. Compile data generated by the clinicians, the patients, and in the laboratory. Determine superiority of one material over the other by statistically testing the rating and ranking data. The failing prosthesis will be eliminated from the study and the patient will be allowed to continue with the successful one.

用人造材料替换人脸和下巴的一部分， 颌面修复术的范围 患者从 皮肤癌、口腔癌、外伤和分娩的手术影响 缺陷需要这些服务。 用于此的现有材料 用途包括硅酮、聚氨酯和乙烯基弹性体。 制成的器件 这种材料的一部分通常在几个月内由于变色而失效， 羽毛边缘磨损、下垂或与粘合剂不相容。 一 1976- 1979年，由Paul D.五月和 Luis R. Guerra使用氯化聚乙烯（CPE），一种工业 由陶氏化学公司生产的弹性体。 有限的临床试验 表明该材料可用于更长时间的试验。 这 项目将继续这项工作，在四个部分：1。CPE材料的改进 从1979年的水平，并测量其物理和生物特性， 自开发以来，用于软义齿衬垫的程序。 探讨 改进的磷酸盐粘结或石膏模具。 2.进行试点研究， 衡量以下方面的可靠性和有效性：a）材料性能测试， 和B）临床医生观察和患者观察的问卷 对现有颌面部假体的认知。 使用该信息来 修改主要临床研究的试验仪器。 3.提供 向慈善医院牙科部提供材料和技术 进行临床试验 20名患者需要口外 将选择颌面修复体。 每人将获得两个 由CPE材料或硅橡胶制成的假体， 每3个月更换一次，连续佩戴。 4.编译生成的数据 由临床医生、患者和实验室完成。 确定 通过统计学检验， 评级和排名数据。 失败的假体将从 研究和患者将被允许继续进行成功的 一个.