Calcium Sulfate Based Bioactive Bone Graft

描述（由申请人提供）：本研究的目的是开发一种用于牙科的改良的合成骨移植材料。牙齿的脱落往往伴随着颌骨的脱落。修复这些丢失的骨头通常是安装植牙和维持正常面部特征的先决条件。硫酸钙是一种很好的骨再生材料。它不仅可以作为缺损填充物，而且具有生物相容性，促进新骨生长，促进新血管生长。然而，其主要缺点是降解快，限制了其在骨移植中的应用。基于成功的一期可行性研究，该项目提出开发一种新材料：具有抗炎特性和骨生长因子输送能力的硫酸钙/可吸收聚合物复合材料。一期研究已经证明，硫酸钙/可吸收聚合物复合材料的降解速度比纯硫酸钙慢，从而克服了这种材料作为骨再生产品的一个重大缺点。现在的计划是开发一种产品，牙医可以在骨移植手术中使用，这将与使用患者自己的骨头所看到的骨再生潜力相媲美。该产品是硫酸钙和聚阿司匹林的复合材料，可提供骨生长因子PDGF，该产品采用了一种新型聚合物，其体内骨反应已在几种动物模型中进行了研究。由于其特殊的化学结构，这种聚合物引起了良好的细胞和组织反应，并在口腔环境中具有重要的抗炎作用。由于该产品的早期版本已经商业化，因此该新产品将迅速推向市场并作为改进的替代品。公共卫生相关性：骨移植是面部和牙齿维护的重要组成部分。最近对同种异体骨供应的关注使得开发一种可靠、负担得起的合成材料对这一过程至关重要。该项目描述了一种具有与自体移植物相媲美的骨再生能力的合成材料的开发，该材料基于一种简单、经济、安全历史悠久的材料，硫酸钙，结合抗炎可吸收聚合物和骨生长因子。

DESCRIPTION (provided by applicant): The aim of this research is to develop an improved, synthetic bone graft material for use in dentistry. The loss of teeth is often accompanied by the loss of jaw bone. Restoring this lost bone is often a prerequisite for the installation of dental implants and the maintenance of normal facial features. Calcium sulfate works quite well as a bone regeneration material. It serves not only as a defect filler, but is also biocompatible, conducts new bone growth and encourages the growth of new blood vessels. However, its fast degradation is its major shortcoming, restricting its use in bone grafting applications. Based upon a successful phase I feasibility study, this project proposes the development of a new material: a calcium sulfate/absorbable polymer composite with anti-inflammatory properties and bone growth factor delivery capability. Phase I studies have already demonstrated that calcium sulfate/ absorbable polymer composites undergo slower degradation than pure calcium sulfate and thus overcomes a significant drawback of this material as a bone regeneration product. The plan now is to develop a product that dentists can use in bone grafting procedures that will rival the bone regeneration potential seen with the use of the patients own harvested bone. The product, a composite of calcium sulfate and Poly-Aspirin that delivers a bone growth factor, PDGF, utilizes a new polymer whose in vivo bone response has been studied in several animal models. Because of its specific chemical structure, this polymer elicits an excellent cell and tissue response and has an anti-inflammatory effect of great value in the oral environment. Since an earlier version of this product has already been commercialized, this new product will be rapidly introduced to the marketplace and an improved replacement. PUBLIC HEALTH RELEVANCE: Bone grafting is an essential component of facial and dental maintenance. Recent concern about allograft bone supply makes the development of a reliable, affordable synthetic essential to this process. This project describes the development of just such a synthetic with bone regeneration capability rivaling autografts based on a simple, affordable material with a long safety history, calcium sulfate, combined with an anti-inflammatory absorbable polymer and a bone growth factor.