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. ? ?
