Bio-Functionalized Ti Implants Via Nanotechnology

描述（由申请人提供）：每年在美国进行数百万例牙科种植手术，估计每年以20%的速度增长。临床牙科社区对新型种植体系统的需求日益增加，该系统可在更具挑战性的病例中提供加速的组织-种植体整合和改进的治疗应用。在I期和I期后研究期间，我们成功地开发了一种纳米技术，用于用纳米结构生物相容性羟基磷灰石处理粗糙植入物的表面。采用低成本的溶胶-凝胶和溶液自组装工艺，通过氨基功能化的二氧化硅生物相容性分子层将20-60 nm厚的纳米HA材料结合到钛植入物表面。体内大鼠推入试验证实，Chemat的纳米HA处理表面可显著加速愈合并改善生物力学强度。仅两周后，新骨/植入物的结合已经如此牢固，以至于生物活化植入物周围的推入式断裂实际上发生在新骨中，而对于对照（未处理）植入物，断裂发生在植入物表面和新骨的界面处。在第一阶段，通过这种纳米技术实现了组织/植入物整合的实质性加速，在两周的时间点，愈合率是对照植入物的两倍多。初步的生物相容性测试显示没有毒性或其他不良反应，并且HA治疗的纳米级性质被认为解决了厚HA涂层所经历的历史问题。现已与一家领先的牙科植入物制造商（“合作伙伴”）签署了一项协议，根据该协议，他们将为进一步开发和评估纳米HA技术提供实质性援助。第n阶段的目标是：（a）进一步开发和优化纳米治疗工艺;（B）将纳米HA功能化植入物的生物学性能研究扩展到早期和长期预防，包括临床试验（其中大部分将由合作伙伴完成）;（c）进一步开发表征处理表面的方法;及（d）发展溶解及处理工序的原型生产线。本计画主要是在市售的微米粗糙化牙科植体上，发展一奈米结构的生物活性功能化表面。这种生物活性纳米结构促进了组织-植入物更快的整合以及植入物和新骨之间更强的结合。该项目的成功将缩短牙齿矫正的愈合时间，并改善骨结构不足患者的治疗效果。

DESCRIPTION (provided by applicant): Millions of dental implant procedures are performed in the US every year, increasing at an estimated rate of 20% per year. There is an increasing demand in clinical dentistry communities for a new implant system that offers accelerated tissue-implant integration and improved treatment application in more challenging cases. During Phase I and post-Phase I research, we successfully developed a nanotechnology for treating the surface of roughened implants with nanostructured biocompatible hydroxyapatite. The 20-60 nm thick nano-HA material is bonded to titanium implant surface via amino functionalized silica biocompatible molecular layer, using low-cost solgel and solution-based self-assembly processes. In vivo rat push-in testing has confirmed significant acceleration of healing and improvement in biomechanical strength is achieved with Chemat's nano-HA treated surfaces. After only two weeks, the bonding of the new bone/implant was already so strong that the push-in fracture around the bioactivated implant actually occurred in the new bone, while for controlled (untreated) implants the fracture occurred at the interface of implant surface and new bone. Substantial acceleration of tissue/implant integration was achieved via this nanotechnology in Phase I, with the rate of healing more than double that for the control implants at the two-week point. Preliminary biocompatibility testing has shown no toxicity or other adverse reactions, and the nano-scale nature of the HA treatment is believed to resolve the historical issues experienced with thick HA coatings. An agreement has now been signed with a leading manufacturer of dental implants (the "Partner") under which they will provide substantial assistance with further development and evaluation of the nano-HA technology. The objectives of Phase n are to (a) further develop and optimize the nano-treatment processes; (b) extend studies of the biological performance of the nano-HA functionalized implants to early stage and long term implantations including clinical trials (much of which will be done by the Partner); (c) further develop methodologies for characterizing the treated surfaces; and (d) develop prototype production lines for solution and treatment processing. This project is to develop a nano-structured bioactive functionalized surface on commercially available micron roughened dental implants. This bioactive nano-structure promotes more rapid tissue-implant integration and stronger bonding between the implant and new bone. Success of this project will result in shorter healing times for dental implantations generally, and improved results for patients with inadequate bone structures.