CLINICAL EVALUATION OF PNF PERMANENT SOFT DENTURE LINERS

PNF 永久软义齿衬垫的临床评估

• 批准号: 3219149
• 负责人: Lawrence M. Gettleman
• 金额: $ 15.31万
• 依托单位: GULF SOUTH RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1980
• 资助国家: 美国
• 起止时间: 1980-03-01 至 1987-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3219149
• 关键词: carbopolycyclic compound; dental bonding material; dentures; elastomers; orthodontic appliances; polyacrylate; polyethylenes; polymers; polystyrenes; polyurethanes; silicone rubber; surface property

Several million removable complete dentures are fabricated, relined, or rebased every year in the United States and most are made of hard acrylic bases which closely fit the maxillae and palate or the mandibular ridge. This hard denture often pinches or irritates the soft tissues lying against the bone. Disease states which make this problem more severe include excessive alveolar ridge resorption, various mucous membrane diseases, bone irregularities, and psychological aversions to wearing dentures. Soft and resilient denture liners have been used to remedy these problems, but such plasticized acrylics, silicone rubbers, polyurethane rubbers, or polyvinyl chlorides are not successful as permanent materials. Previous work at GSRI, partly funded by NIDR, has led to the development of polyphosphazine fluoroelastomer (PNF) for use as permanent soft denture liner. This rubber was developed by Firestone Tire and Rubber Company and has excellent mechanical properties. The development at GSRI has achieved curing at boiling water temperatures, good bonding to acrylic and both a soft and firm material for use in the denture over the bony anatomy and at the periphery of the denture, respectively. Lab testing and toxicity studies are essentially complete and indicate the need for human trials. A clinical study is proposed via subcontracts to Northwestern University Dental School (Postgraduate Prosthodontic Clinic) and Charity Hospital in New Orleans (Dental Department). In a pilot study, a battery of fabrication, physical property, clinician evaluation and patient-evaluation tests will be conducted to detemine their reliability and validity, using patients now wearing temporary soft liners. The principal study will treat 70 patients at Northwestern and 35 patients at Charity Hospital over 4.5 years by constructing sets of dentures with PNF in one denture and a commercial silicone rubber liner in the other. The patient will act as his/her own control. At three-month (later six-month) intervals, patients will be recalled and evaluated. Data will be statistically tested to control the effects of the different medical centers, and will be directed toward determining whether or not PNF is superior to silicone rubber.

数百万个可移动的全口义齿被制造，重新排列，或 在美国，每年都有新的基地，大多数都是由硬丙烯酸制成的 与上颌骨和上颚或下颌骨嵴紧密贴合的基部。 这种坚硬的假牙经常会挤压或刺激软组织 骨头 使这一问题更加严重的疾病状态包括 牙槽嵴过度吸收，各种粘膜疾病，骨 不规则，以及对戴假牙的心理厌恶。 柔软和 弹性义齿衬垫已被用于补救这些问题，但是， 增塑丙烯酸树脂、硅橡胶、聚氨酯橡胶或聚乙烯 氯化物作为永久性材料并不成功。 以前的工作 由NIDR部分资助的GSRI已经导致了聚磷嗪的开发 含氟弹性体（PNF）用作永久性软义齿衬垫。 该橡胶 是由凡士通轮胎橡胶公司开发的，具有优良的 力学性能 GSRI的发展已经实现了固化， 沸水温度，良好的粘合丙烯酸和既软， 坚固的材料，用于在骨性解剖结构上和 义齿的边缘，分别。 实验室测试和毒性研究 基本上已经完成，并表明需要进行人体试验。 一 通过分包合同向西北大学提出临床研究 牙科学校（研究生口腔修复诊所）和慈善医院， 新奥尔良（牙科部）。 在一项试点研究中， 制造、物理性能、临床医生评价和患者评价 将进行测试，以确定其可靠性和有效性，使用 患者现在使用临时软衬垫。 主要研究将治疗 70名患者在西北和35名患者在慈善医院超过4.5 年，通过构建一个义齿和一个PNF的义齿组， 商业硅橡胶衬垫在另一个。 患者将作为 自己的控制。 每隔三个月（后来是六个月），患者 将被召回并评估。 将对数据进行统计学检验， 控制不同医疗中心的效果，并将被指示 以确定PNF是否优于硅橡胶上级。