A Novel Biomimetic Bone Cement For Immediately Loaded Dental Implants

描述（由申请人提供）：到2010年，种植体牙科重建产品的全球市场将接近35亿美元，年增长率为15%。目前，种植患者从拔牙开始等待3-14个月，直到一个功能齐全的冠到位，这给患者带来了极大的不便，而且整个过程的成本也很高。这项小型企业技术转移研究（STTR）提案的目标是开发一种新型骨水泥种植体系统，可以消除等待时间并为患者提供更广泛的服务。由于生物和机械的原因，目前可用的骨水泥如聚（甲基丙烯酸甲酯）水泥和磷酸钙水泥通常用于骨水泥骨科植入物（例如，髋关节和膝关节）不适合颌骨（牙科）植入物。我们开发了一种溶胶凝胶修饰的仿生羟基磷灰石-明胶纳米复合材料，称为gemsil，它有很大的潜力成为一种骨水泥，可以立即加载牙科种植体。我们期望GEMOSIL的机械性能和作为骨骼生长支架的能力的结合，将使患者在拔牙的同一天内获得功能正常的牙齿替换。如果成功，这将是第一个商业化的骨水泥种植体系统。在这个一期项目中，我们将重点开发和优化用于即刻加载牙科种植体的GEMOSIL。提出了两个具体目标：1)开发使用GEMOSIL生物材料的腻子水泥工艺；2)使用小动物进行体内试验。这些目标的完成将创造新的水泥，并证明新的水泥可以在体内使用。该结果将为我们的第二阶段研究奠定基础，以进一步开发技术并将产品商业化。我们的产品最初的市场将是作为牙种植体的骨增强和锚定材料，这将对患者产生立竿见影的积极影响。GEMOSIL在美国牙科种植应用的潜在市场估计约为1亿美元。其他下游的好处包括提供一种新的组织工程生物材料来替代先天性、发展性或创伤性骨畸形患者的缺失组织。我们相信，我们的产品不仅可以成功地打入种植体市场，而且可以扩大种植体市场。

DESCRIPTION (provided by applicant): The worldwide market for implant-based dental reconstruction products will approach nearly $3.5 billion by 2010 with an annual growth rate of 15%. Currently, an implant patient waits 3-14 months from the time of tooth extraction until a functioning crown is in place, resulting in significant inconvenience for the patient and high cost for the overall procedure. The goal of this Small Business Technology Transfer Research (STTR) proposal is to develop a novel cemented dental implant system that can eliminate the waiting time and provide broader service for patients. Due to biological and mechanical reasons, the currently available bone cements such as poly(methyl methacrylate) cement and calcium phosphate cement typically used in the cemented orthopedic implants (e.g., hip and knee) are not suitable for jawbone (dental) implants. We have developed a sol gel modified biomimetic hydroxyapatite-gelatin nano- composite, called GEMOSIL, that has great potential to be a bone cement that can permit the immediate loading of dental implants. We expect that GEMOSIL's combination of mechanical properties and capability to be a scaffold for bone growth will allow patients to have a functioning tooth replacement in the same day as tooth extraction. If successful, this will provide the first commercial system for the cemented dental implant. In this Phase I project, we will focus on the development and optimization of GEMOSIL for immediately loaded dental implants. Two specific aims are proposed: 1) Develop a process for putty cement using GEMOSIL biomaterials, and 2) Perform a pilot in vivo test using small animals. The completion of these aims will create new cement and demonstrate that the new cement can be used in vivo. The outcome will position us for the Phase II study to further develop the technology and commercialize the product. The initial market for our product will be as a bone augmentation and anchoring material for dental implants, which will have immediate and significant positive benefits to patients. The addressable market in the US for the dental implant application of GEMOSIL is estimated to be approximately $100M. Other downstream benefits include providing a new tissue engineering biomaterial to replace missing tissues in patients with congenital, developmental or trauma-induced bone deformities. With significant advantages over alternatives, we believe that our product not only can successfully penetrate but also enhance the dental implant market. PUBLIC HEALTH RELEVANCE: Currently, an implant patient needs to wait for 3 -14 months from the time of tooth extraction until he/she has a functioning tooth replacement, resulting in the significant inconvenience for the patient and the high cost of the procedure. The goal of this STTR proposal is to develop a novel GEMOSIL cemented dental implant system that can eliminate the waiting time and provide broader service for disparity patients. We expect that GEMOSIL's combination of mechanical properties and capability to be a scaffold for bone growth will allow patients to have a functioning tooth replacement in the same day as tooth extraction.