A Novel Surface Modification for Dental Implants

描述（由申请人提供）：这项持续的研究旨在评估钛牙种植体表面新型表面修饰的适用性，以仿生方式诱导早期成骨细胞反应和矿化，以改善骨与种植体的相互作用。据估计，仅在美国，每年就有超过100万的牙科和骨相关的假体被放置。其中总共有11%以失败告终，除了给病人带来巨大的痛苦外，还在医疗成本和生产力损失方面给经济造成了数十亿美元的损失。根据一份政府报告，与植入失败相关的最常见并发症是它们的松动。因此，研究的意义，可以导致永久锚定牙种植产品是巨大的。它是种植体与宿主组织直接接触的表面，因此在决定种植体表面的生物相容性和诱导生物活性方面起着至关重要的作用。目前迫切需要一种能够仿生诱导种植体表面与周围组织之间的成骨活性的表面修饰技术，以实现骨-种植体界面的真正整合。在成功完成本研究的第二阶段，即确定最佳成骨涂层并扩大其规模，确保质量控制并验证在钛植入物上创建涂层的标准操作程序后，该产品将在获得FDA批准后准备推向市场。因此，在本研究完成后，将向FDA提交上市前通知和其他必要的通知，以升级产品，使其适合未来的临床研究。

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.