A Novel Surface Modification for Dental Implants

描述（由申请人提供）：该持续努力旨在评价钛牙科种植体表面新型表面改性对生物仿生诱导早期成骨细胞反应和矿化以改善骨-种植体相互作用的适用性。据估计，仅在美国，每年就有超过一百万的牙齿和骨骼相关假体被放置。其中有11%以失败告终，除了给患者带来巨大痛苦外，还造成了数十亿美元的医疗成本和生产力损失。根据一份政府报告，与植入物失效相关的最常见并发症是松动。因此，研究可以导致永久锚定牙科种植体产品的意义是巨大的。它是与宿主组织保持直接接触的植入物表面，因此在确定植入物表面的生物相容性和生物活性诱导方面起着关键作用。目前迫切需要一种能够在种植体表面与周围组织之间生物仿生诱导成骨的表面改性技术，以实现骨-种植体界面的真正整合。在成功完成本研究的第2阶段（确定最佳成骨涂层及其规模扩大，确保质量控制和钛植入物涂层创建程序的标准操作程序确认）后，产品将在获得FDA批准后准备上市。因此，在本研究完成后，将向FDA提交上市前通知和其他要求的通知，以升级产品，使其适用于未来的临床研究。

DESCRIPTION (provided by applicant): This continued effort is directed to evaluate the applicability of a novel surface modification on titanium Dental implant surfaces to biomimetically induce early osteoblast response and mineralization to improve bone-implant interaction. It is estimated that in U.S. alone more than a million Dental and bone related prostheses are placed annually. A total of 11% of these end up in failures, costing billions of dollars to the economy in terms of health-care costs and lost productivity, besides immense pain to the patients. According to a government report, the most common complication related to implant failures is their loosening. Therefore, the significance of research that can lead to a permanently anchored Dental implant product is immense. It is the surface of an implant that remains in direct contact with the host tissue, and therefore it plays a critical role in determining biocompatibility and induction of bioactivity on implant surface. A technique of surface modification that can biomimetically induce osteogenic activities between implant surface and the surrounding tissue is the desperate need at present to bring a true integration at bone-implant interface. After the successful completion of the Phase 2 of this research on identification of an optimum osteogenic coating and its scale up with assured quality control and validation of standard operating procedure on the procedure to create the coating on Ti implants, the product will be made ready to be brought to the market place after an approval from FDA. Therefore, after the completion of this research, Pre-market Notification and other required notifications will be filed with FDA to upgrade the product to be suitable for clinical studies in future.