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合成骨移植材料。牙齿的缺失往往伴随着颌骨的缺失。恢复这种丢失的骨骼通常是安装牙科植入物和维持正常面部特征的先决条件。硫酸钙作为骨再生材料效果很好。它不仅作为缺损填充物，而且具有生物相容性，可引导新骨生长并促进新血管生长。然而，其快速降解是其主要缺点，限制了其在骨移植应用中的使用。基于成功的I期可行性研究，该项目提出了一种新材料的开发：硫酸钙/可吸收聚合物复合材料，具有上级的生物相容性和骨相容性以及骨生长因子输送能力。I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，因此克服了这种材料作为骨再生产品的显著缺点。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，这种产品将与使用患者自己的骨再生潜力相媲美。该产品是硫酸钙和聚DTE碳酸酯的复合物，可输送骨生长因子rhBMP-2，采用了一种新的聚合物，已在几种动物模型中研究了其体内骨反应。由于其特殊的化学结构，这种聚合物具有优异的细胞和组织反应。由于该产品的早期版本已经商业化，因此该新产品将作为改进的替代品迅速推向市场。 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的、负担得起的合成骨对于该过程至关重要。该项目描述了这样一种具有骨再生能力的合成物的开发，该合成物基于具有长期安全历史的简单，负担得起的材料硫酸钙，结合新的高度骨相容性和生物相容性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 superior biocompatibility and bone-compatibility 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 DTE carbonate that delivers a bone growth factor, rhBMP-2, 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. Since an earlier version of this product has already been commercialized, this new product will be rapidly introduced to the marketplace as 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 a new highly bone-compatible and biocompatible polymer and a bone growth factor.