Bio-Functionalized Ti Implants Via Nanotechnology

通过纳米技术实现生物功能化钛植入物

• 批准号: 7051652
• 负责人: Yuhong Huang
• 金额: $ 40.9万
• 依托单位: CHEMAT TECHNOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7051652
• 关键词: bone; implant; nanotechnology

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.

描述（由申请人提供）：每年在美国进行数百万个牙科植入程序，以每年20％的估计速度增加。在更具挑战性的情况下，临床牙科界对新植入物系统的需求不断增长，该系统提供了加速的组织植入物整合并改善了治疗应用。在第一阶段和第I阶段研究期间，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的植入物表面。使用低成本溶液和基于溶液的自组装过程，将20-60 nm厚的纳米-HA材料通过氨基官能化的二氧化硅生物相容性分子层粘合到钛植入物表面。体内大鼠推入测试已经证实，通过Chemat的纳米HA处理的表面可以实现愈合的显着加速和生物力学强度的改善。仅两周后，新骨/植入物的粘结已经变得如此牢固，以至于在新骨骼中实际上发生了生物活化植入物周围的裂缝，而用于受控（未处理的）植入物，裂缝发生在植入物表面的界面上和新的骨头。通过该纳米技术在I期实现了组织/植入物整合的大量加速，其愈合率是两周的对照植入物的两倍以上。初步的生物相容性测试未显示毒性或其他不良反应，HA处理的纳米级性质被认为可以解决厚HA涂层所经历的历史问题。现在已经与牙科植入物（“合作伙伴”）的主要制造商签署了一项协议，他们将在该协议中为纳米-HA技术的进一步开发和评估提供大量帮助。 N期的目标是（a）进一步开发和优化纳米处理过程； （b）将纳米-HA功能化植入物的生物学性能扩展到早期和长期植入物，包括临床试验（其中大部分将由伴侣完成）； （c）进一步开发用于表征处理过的表面的方法； （d）开发用于解决方案和处理处理的原型生产线。该项目旨在在市售的微米粗糙的牙科植入物上开发纳米结构的生物活性功能化表面。这种生物活性纳米结构可促进植入物和新骨之间更快的组织植入物整合和更强的键合。该项目的成功通常会导致牙齿植入的愈合时间较短，并改善了骨结构不足的患者的结果。