CLINICAL EVALUATION OF PNF PERMANENT SOFT DENTURE LINERS

数以百万计的可拆卸全口义齿被制造、重新修复或 美国每年都会更换基座，大多数都是硬质亚克力 与上颌、上颌或下颌骨紧密贴合的基托。 这种硬义齿经常挤压或刺激靠在其上的软组织。 骨头。使这一问题更加严重的疾病状态包括 牙槽骨过度吸收，各种黏膜病，骨 不规范，以及对戴假牙的心理厌恶。柔软和 有弹性的义齿衬垫已经被用来解决这些问题，但这样的 塑化丙烯酸酯、硅橡胶、聚亚安酯橡胶或聚乙烯 氯化物作为永久性材料是不成功的。之前的工作在 由NIDR提供部分资金的GSRI导致了聚磷腈的开发 用于永久软性义齿衬里的氟橡胶(PNF)。这种橡胶 是由凡士通轮胎橡胶公司开发的，具有出色的 机械性能。GSRI的发展已经实现了 沸水温度，与丙烯酸有良好的粘合力，既柔软又 坚固的材料，用于覆盖骨骼解剖的义齿和 分别位于义齿的外围。实验室检测和毒性研究 基本完成，表明有必要进行人体试验。一个 临床研究通过分包合同提交给西北大学 牙科学校(口腔修复专业研究生诊所)和慈善医院 新奥尔良(牙科)。在一项初步研究中，一组 制造、物理性能、临床医生评估和患者评估 将进行测试，以确定其可靠性和有效性，使用 病人现在穿着临时的软衬垫。主要的研究将治疗 西北大学70名患者和慈善医院超过4.5岁的35名患者 通过在一个义齿和一个义齿中使用PNF构建多组义齿 商用硅橡胶衬里在另一处。病人将扮演 他/她自己的控制权。每隔三个月(后来是六个月)，患者 将被召回并进行评估。数据将进行统计检验，以 控制不同医疗中心的效果，并将指导 以确定PNF是否优于硅橡胶。

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.