A Novel Biomimetic Bone Cement For Immediately Loaded Dental Implants

描述(申请人提供)：到2010年，以种植体为基础的牙齿重建产品的全球市场将接近35亿美元，年增长率为15%。目前，种植体患者从拔牙起要等3-14个月，直到功能正常的牙冠就位，这给患者带来了极大的不便，整个手术的成本也很高。这项小企业技术转移研究(STTR)提案的目标是开发一种新型的骨水泥种植系统，可以减少等待时间，为患者提供更广泛的服务。由于生物和机械方面的原因，目前骨水泥如聚甲基丙烯酸甲酯和磷酸钙骨水泥通常用于骨水泥骨科植入物(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GEMOSIL，它很有可能成为一种可以立即加载牙种植体的骨水泥。我们预计，GEMOSIL的机械性能和能力相结合，将成为骨生长的支架，使患者能够在拔牙的同一天进行功能正常的牙齿替换。如果成功，这将为粘结式牙种植体提供第一个商业系统。在这个第一阶段的项目中，我们将重点开发和优化用于即刻加载的牙种植体的GEMOSIL。提出了两个具体的目标：1)开发一种使用GEMOSIL生物材料的油灰水泥工艺，以及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。这一结果将使我们为进一步开发技术和产品商业化的第二阶段研究奠定基础。我们产品的最初市场将是作为牙科植入物的骨增强和锚定材料，这将对患者产生直接和重大的积极好处。GEMOSIL的牙科植入物应用在美国的潜在市场估计约为1亿美元。其他下游好处包括提供一种新的组织工程生物材料，以取代先天性、发育性或外伤性骨畸形患者缺失的组织。与其他产品相比，我们的产品具有显著的优势，我们相信我们的产品不仅可以成功地渗透到牙科植入物市场，还可以促进牙种植体市场的发展。 公共卫生相关性：目前，种植牙的患者从拔牙到进行功能正常的牙齿替换需要等待3-14个月，这给患者带来了极大的不便，并导致了高昂的手术费用。这项建议的目标是开发一种新型的GEMOSIL骨水泥种植系统，可以减少等待时间，为视差患者提供更广泛的服务。我们预计，GEMOSIL的机械性能和能力相结合，将成为骨生长的支架，使患者能够在拔牙的同一天进行功能正常的牙齿替换。

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.