Objective

Polysaccharide-based composite matrices consisting of natural polysaccharides, pullulan and dextran supplemented with hydroxyapatite (Matrix-HA) have recently been developed. The principal objective of this study was to evaluate the capacities of this composite material to promote new bone formation in a sinus lift model in the sheep. Secondary objectives were to evaluate in vitro properties of the material regarding cell adhesion and proliferation.

Methods

In this report, once such composite matrix was prepared as injectable beads after dispersion in a physiological buffer, and evaluated using a large animal model (sheep) for a sinus lift procedure.

Results

In vitro studies revealed that these microbeads (250–550 μm in diameter) allow vascular cell adhesion and proliferation of Endothelial Cells (EC) after 1 and 7 days of culture. In vivo studies were performed in 12 adult sheep, and newly formed tissue was analyzed by Cone Beam Computed Tomography (CBCT scanning electron microscopy (SEM) and by histology 3 and 6 months post-implantation. CBCT analyses at the implantation time revealed the radiolucent properties of these matrices. Quantitative analysis showed an increase of a dense mineralized tissue in the Matrix-HA group up to 3 months of implantation. The mineralized volume over total volume after 6 months reached comparable values to those obtained for Bio-Oss^® used as positive control. Histological examination confirmed that the Matrix-HA did not induce any long term inflammatory events, and promoted direct contact between the osteoid tissue and lamellar bone structures and beads. After 6 months, we observed a dense network of osteocytes surrounding both biomaterials as well as a newly vascularized formed tissue in close contact to the biomaterials.

Significance

In conclusion, the absence of animal components in Matrix-HA, the osteoconductive property of Matrix-HA in sheep, resulting in a dense bone and vascularized tissue, and the initial radiolucent property to follow graft integration offer great promises of this composite material for clinical use.

中文翻译：

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用于鼻窦底增大术的可注射多糖-羟基磷灰石复合材料的体外和体内设计与验证

客观的

最近已经开发了由天然多糖，支链淀粉和右旋糖酐加羟基磷灰石（Matrix-HA）组成的基于多糖的复合基质。这项研究的主要目的是评估这种复合材料在绵羊鼻窦举升模型中促进新骨形成的能力。次要目的是评估该材料在细胞粘附和增殖方面的体外特性。

方法

在该报告中，一旦将这种复合基质制成在生理缓冲液中分散后的可注射小珠，并使用大型动物模型（绵羊）对窦提拉程序进行了评估。

结果

体外研究表明，这些微珠（直径250-550μm）在培养1天和7天后可使血管细胞粘附和内皮细胞（EC）增殖。在12只成年绵羊中进行了体内研究，并在植入后3个月和6个月通过锥束计算机断层扫描（CBCT扫描电子显微镜（SEM）以及组织学）对新形成的组织进行了分析。的这些矩阵。定量分析表明矩阵-HA组长达3个月植入在密集矿化组织的增加。矿化的体积超过总体积6个月后达到可比值，为生物奥斯获得的那些^®用作阳性对照。组织学检查证实，Matrix-HA不会引起任何长期的炎症事件，并促进了类骨组织与层状骨结构和珠粒之间的直接接触。6个月后，我们观察到了围绕着两种生物材料以及与生物材料紧密接触的新血管化组织的密集的骨细胞网络。

意义

总之，Matrix-HA中没有动物成分，Matrix-HA在羊中具有骨传导特性，导致致密的骨骼和血管化组织，以及移植物整合后的初始射线可透性，为这种复合材料的临床应用提供了广阔的前景采用。