The titanium PV I endosteal implant from beta-titanium alloy Ti 38Nb 6Ta.

IF 0.7
Patrik Prachar, Sonia Bartakova, Jiri Vanek
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引用次数: 3

Abstract

Aim: The aim of this study was to use the beta-titanium alloy Ti38Nb6Ta for production of a new construction line of implants, perform testing on animals and preclinical tests.

Materials and methods: Within this study, a new PV I implant with five construction variants was developed. The implant includes three types of threads - microthreads and flat threads of two types with a different depth. Further, the PV I implant was tested on minipigs. Subsequently, preclinical tests of 150 implants were performed and assessed. The age interval of patients was from 18 to 74 years.

Results: Beta titanium alloy exhibited higher strength than titanium alloys. Anti-corrosion resistance was also higher. The implant from beta-alloy was inserted in the tibias of minipigs. Sections showed good osseointegration of the PV I implant. During the preclinical tests, 150 implants were inserted with the success rate of 99.33% after the two year assessment. The assessment also included handicapped patients who are not usually assessed in classical studies. Finally, the implantation protocol and documentation of a new implantation system PV I was designed. At the same time the industrial sample of this implant was formed and accepted.

Conclusion: A new anti-rotation PV I implant with microthreads and conical anchorage of the abutment into the fixture was formed. The beta-titanium alloy Ti38Nb6Ta used for the implant was biocompatible and had higher mechanical and physical properties than the existing titanium alloys. The PV I implant was recommended for clinical application.

β -钛合金Ti 38Nb 6Ta制备的钛PV - I内嵌体。
目的:本研究的目的是利用β -钛合金Ti38Nb6Ta生产一种新的种植体结构线,进行动物试验和临床前试验。材料和方法:在本研究中,开发了一种具有五种结构变体的新型PV I种植体。植入物包括三种类型的螺纹-微螺纹和两种不同深度的平螺纹。此外,PV I植入物在小型猪上进行了测试。随后,进行了150个植入物的临床前测试并进行了评估。患者年龄间隔为18 ~ 74岁。结果:β钛合金比钛合金具有更高的强度。耐腐蚀性能也较高。将β -合金植入体置入小型猪胫骨。切片显示PV - I种植体骨整合良好。在临床前试验中,共植入150颗种植体,经过两年的评估,成功率为99.33%。该评估还包括在经典研究中通常不被评估的残疾患者。最后,设计了新型植入系统PV - 1的植入方案和文件。同时,该植入物的工业样品形成并接受。结论:形成了一种新型的抗旋转PV - I种植体,其微螺纹与基台的锥形支抗结合。所制备的β -钛合金Ti38Nb6Ta具有生物相容性,并且比现有钛合金具有更高的力学和物理性能。pvi型种植体被推荐用于临床应用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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