Feasibility study of a nanostructural system for bone regeneration in preparation for dental implants

项目摘要 目前用于牙种植体功能康复的骨移植技术存在局限性-高- 成本高，固定和稳定困难，骨再生不足，自体骨移植的发病率高 阻断移植物并延长愈合时间长达9个月。现有的合成骨填充物不能匹配缺陷形状 和体积，是弱吸收的(如果有的话)，在手术期间在大小和形状上不容易和快速地改变， 不能促进早期和增强的新生血管和骨整合；不适合于 高级重建。目前的技术无法进行调整，以匹配现有的骨骼结构-a 改善愈合的关键功能。虽然种植前重建手术是常见的，但一种 由于这些限制，估计有7%的患者无法接受牙科植入物。我们打算证明 我们的NuCressTM支架是骨愈合方面的革命性进步和变革性技术 适用于牙医、牙周病医生和口腔外科医生。我们试图在临床前研究中证明牙种植体或其他 骨再生治疗的牙齿挽救治疗可以进行的费用和愈合的一小部分 今天的技术所需的时间。我们建议展示我们的技术支持 矿化组织的再生，概括了骨组织的机械、物理和生物特性 颅面部骨骼和相应的微环境，以促进改进的牙种植体成功。我们 假设NuCress™支架技术将在兔子和 犬骨再生模型的建立。在生产出具有类似于颅骨的增孔性的优化支架后 骨，我们将比较NuCress™支架与谓词组和未处理的对照组在关键的 颅骨缺损大小，在已建立的鼻窦模型中，已建立的临床前颅窝模型中，已建立 临床前节段性缺陷模型，以及已建立的临床前种植模型。成功的第一阶段 和II SBIR研究将导致在牙科种植患者中进行第一次人体试验，并寻求FDA的批准，以提供 一个更好的选择，以促进改进的牙种植体成功。

Project Summary Current bone grafting techniques for functional rehabilitation with dental implants have limitations – high- cost, difficulties with fixation and stabilization, insufficient bone regeneration, high morbidity using autogenous block grafts and prolonged healing of up to 9 months. Existing synthetic bone fillers cannot match defect shape and volume, are weakly resorbed (if at all), are not easily and quickly modifiable in size and shape during surgery, cannot promote early and enhanced neovascularization and osseointegration; and are poorly suited for advanced reconstruction. Current technologies cannot be modulated to match existing bone architecture – a critical feature for improved healing. Although pre-implant reconstructive surgeries are commonly performed, an estimated 7% of patients are unable to receive dental implants due to these limitations. We propose to prove that our NuCressTM scaffold is a revolutionary advancement in bone healing and a transformational technology for dentists, periodontists and oral surgeons. We seek to prove in preclinical studies that dental implants or other bone regeneration treatments for tooth salvage treatments can be performed at a fraction of the cost and healing times required for today’s technologies. We propose to demonstrate the ability of our technology to support regeneration of mineralized tissues that recapitulate the mechanical, physical and biological properties of craniofacial bones and corresponding microenvironments, to facilitate improved dental implant success. We hypothesize that the NuCress™ scaffold technology will outperform currently available options in rabbit and canine bone regeneration models. After producing optimized scaffolds with enhanced porosity similar to calvarial bone, we will compare the NuCress™ scaffold to a predicate and untreated control groups in models of critical sized calvarial defects, in an established sinus model, an established pre-clinical socket model, an established pre-clinical segmental defect model, and an established pre-clinical dental implant model. Successful Phase I and II SBIR studies will lead to first in human trials in dental implant patients and seek FDA approval to provide a superior option to facilitate improved dental implant success.