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

项目摘要 目前用于牙科植入物功能康复的骨移植技术具有局限性-高- 成本、固定和稳定困难、骨再生不足、使用自体骨的高发病率 块移植和延长愈合长达9个月。现有的合成骨填充物无法匹配缺损形状 和体积，被弱地再吸收（如果有的话），在手术期间不能容易和快速地改变尺寸和形状， 不能促进早期和增强的新血管形成和骨整合;并且不适合 先进的重建目前的技术无法调整以匹配现有的骨结构- a 改善愈合的关键特征。尽管通常进行植入前重建手术， 估计有7%的患者由于这些限制而无法接受牙科植入物。我们打算证明 我们的NuCressTM支架是骨愈合领域的革命性进步，是一项变革性技术 牙医牙周病学家和口腔外科医生我们试图在临床前研究中证明，牙科植入物或其他 用于牙齿挽救治疗的骨再生治疗可以以一小部分的成本和愈合 今天的技术所需要的时间。我们建议展示我们的技术支持能力 再生的矿化组织，概括的机械，物理和生物学特性， 颅面骨和相应的微环境，以促进提高牙科植入物的成功率。我们 假设NuCress™支架技术在兔中的表现将优于目前可用的选择， 犬骨再生模型。在生产出具有类似于颅骨的增强孔隙率的优化支架后， 我们将在严重骨损伤模型中将NuCress™支架与等同器械和未处理对照组进行比较。 大小的颅骨缺损，在已建立的窦模型、已建立的临床前牙槽模型、已建立的 临床前节段性缺损模型和已建立的临床前牙种植体模型。成功的第一阶段 和II SBIR研究将导致首次在牙科植入患者中进行人体试验，并寻求FDA批准， 一种上级选择，以促进提高牙科植入物的成功率。

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.