CLINICAL EVALUATION OF CPE IN MAXILLOFACIAL PROSTHESES

颌面修复体中 CPE 的临床评估

• 批准号: 3219977
• 负责人: Lawrence M. Gettleman
• 金额: $ 7.36万
• 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 1987-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3219977
• 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.

用人造材料替换面部和下巴的部分是 颌面部修复术的范围。正在康复的病人 皮肤癌、口腔癌、创伤和分娩的手术效果 缺陷是需要这些服务的。用于此目的的现有材料 用途包括有机硅、聚亚安酯和乙烯基弹性体。制造的设备 这种材料通常由于变色而在几个月内失效， 羽毛边缘磨损、下垂或与粘合剂不相容。一个 发展计划于1976-79年在GSRI由保罗·D·梅和 路易斯·R·格拉使用氯化聚乙烯(CPE)，工业 陶氏化学公司生产的弹性体。有限的临床试验 表示材料对于更长时间的试验是令人满意的。这 项目将从四个方面继续这项工作：1.改进CPE材料 从1979年的水平开始，使用以下方法测量其物理和生物特性 此后开发的用于软义齿衬里的程序。调查 改进的磷酸盐粘结或石膏模具。2.进行试点研究，以 测量以下各项的可靠性和有效性：a)材料性能测试； 和b)临床医生观察和患者观察的调查问卷 对现有颌面部假体的感知。使用此信息来 修改主要临床研究的测试仪器。3.提供 捐赠给慈善医院牙科的材料和技术 新奥尔良的临床试验。20名需要口腔外治疗的患者 将选择颌面部假体。每人将得到两个 假体，由CPE材料或硅橡胶制成， 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、病人和实验室进行。测定 通过统计检验一种材料相对于另一种材料的优越性 评级和排名数据。失败的假体将被从 研究和患者将被允许继续进行成功的 一。