Highly Oriented PEEK/PEEK Composites for Dental Implant

第一阶段研究证实了高度定向聚醚醚酮和碳纤维增强聚醚醚酮(CFR-PEEK)作为表面磷化牙种植体的可行性，并且这些种植体可以被微质化以增强骨整合。在第一阶段的研究中，将表面磷酸化的微结构聚醚醚酮和CRF-PEEK组成的棒经皮质植入山羊无牙下颌骨中，并在12周时进行骨整合评估。结果表明：(1)PEEK的固相取向增加了弹性系数；(2)PEEK的磷酸化促进了骨结合；(3)表面微纹理和将钙固定到磷酸化的PEEK表面，进一步促进了骨结合。这些结果和在PEEK上进行的Poly-Med的其他研究清楚地表明，几种聚合物工程选项可以生产最佳的骨内牙种植体(EDI)。因此，第二阶段研究的选择将包括固态取向、纤维超拉伸、表面磷酸化、纤维增强和聚醚醚酮的自我增强。第二阶段研究的最终目标将是设计一种新型的无水泥EDI，它将不会出现金属EDI的生物和生物力学缺陷。第二阶段的目标与此目标一致，将是：(1)使用表面磷酸化、固态取向和放射化学杀菌，以优化制备固态取向的PEEK、CFR-PEEK复合材料和纤维自增强PEEK复合材料；(2)设计和构建三种类型的EDI，植入犬模型，定量口腔内的生物反应，并与商用钛EDI进行比较；(3)选择一种基于PEEK的EDI，用于优化和最终确定第三阶段的方案；以及(4)为规划和执行第三阶段的协作确定营销合作伙伴。第三阶段的工作将涉及(1)选定EDI的最终开发和扩大，以及(2)进行相关研究以满足监管部门的批准。拟议的商业应用：第二阶段的结果将为最终确定选定的骨内植入物进行中试生产和执行第三阶段的安全性和临床研究提供关键数据。第三阶段的成功完成将导致首次推出用于固定人工牙和桥接人工牙的无水泥聚合物EDI。这项技术还将扩展到几个整形外科应用。

The Phase I study demonstrated the feasibility that highly oriented PEEK and carbon-fiber-reinforced PEEK (CFR-PEEK) could be engineered as surface phosphonylated dental implants and these implants could be microtextured to enhance osseointegration. In the Phase I study, surface-phosphonylated and microtextured rods composed of solid-state oriented PEEK and CRF-PEEK were implanted transcortically in edentulous mandibles in goats and were assessed at 12 weeks for osseointegration. The results indicated (1) solid-state orientation of PEEK increased modulus; (2) phosphonylation of PEEK promoted osseointegration; and (3) osseointegration was further enhanced by surface microtexturing and immobilizing calcium to the phosphonylated PEEK surface. These results and additional studies at Poly-Med on PEEK clearly indicate several polymer engineering options can produce an optimum endosteal dental implant (EDI). Therefore, the options for the Phase II study will include solid-state orientation, fiber-ultradrawing, surface phosphonylation, fiber reinforcement, and self-reinforcement of PEEK. The ultimate goal for the Phase II study will be to engineer a novel cementless, EDI that will not have the biological and biomechanical deficiencies of metallic EDIs. Phase II objectives are consistent with this goal and will be to (1) use surface phosphonylation, solid-state orientation, and radiochemical sterilization, for optimized preparation of solid-state oriented PEEK, CFR-PEEK composites, and fiber self- reinforced PEEK composites; (2) design and construct three types of EDIs, implant in a dog model, quantitate biological responses intraorally, and compare to a commercial titanium EDI; (3) select one type of PEEK-based EDI for optimizing and finalizing plans for Phase III; and (4) identify a marketing partner for collaboration for planning and executing Phase III. Phase III efforts will address (1) final development and scale-up of the selected EDI and (2) conducting relevant studies to meet regulatory approval. PROPOSED COMMERCIAL APPLICATION: Phase II results will provide critical data for finalizing the selected endosteal implant for pilot-scale production and executing the safety and clinical studies in Phase III. Successful completion of Phase III will lead to the first introduction of a cementless, polymeric EDI for anchoring artificial teeth and bridging to natural ones. This technology will also be extended to several orthopedic applications.