oa Novel biomaterial for bone grafting and healing synthesized from bovine serum albumin using sub-critical water technology

The interest in bone and softtissue replacement achieves rapid advances throughout the last decades. Injured bone has a unique ability to regenerate which leads to complete anatomic and physiologic repair. However, not every bony defect can beself-repaired. Repair of large osseous defects caused by neoplasms, cysts, trauma, infection, congenital diseases and surgical intervention are major problems in oral and maxillofacial field. The current approach is to use bone and bone substitutes for filling such defects. The aims of filling such osseous defects are to preserve the morphologic contour, restoration of the mechanical strength and function, elimination of the dead space to reduce postoperative infection, and the prevention of ingrowths of soft tissue. When conditions are favorable for regeneration of bone, such goals can be achieved without the need for grafting techniques. However, in many large lesions or in the absence of favorable conditions in small defects, the morphological contour is not completely restored and the bone remains weak. Different grafting materials have been introduced into the field in the last decade. The profound limitations of biological grafts have prompted the use of synthetic materials as an alternative to autogenous and allogenic bone grafts.In the present invention, we succeeded in manufacturing of a novel biomaterial in the field of bone healing. Our novel biomaterial synthesized from bovine serumalbumin using our newly developed technology (sub-critical water technology). The biomaterial showed a variety of mechanical properties and biodegradability that allowed for its application in the biomedical field and in particular as an alloplastic bone substitute. In our way to validate the applicability of our novel biomaterial, we co-operated with the department of Oral and Maxillofacial Surgery Faculty of Dentistry, Al Minia University, to evaluate our material as an alloplastic bone substitute through animal test. The results revealed satisfactory results when used as a bone grafting material in surgically created bone defects in the rabbit models. The obtained results showed that these novel materials have the following properties: Biocompatibility, Nontoxic and nonirritant, Act as a haemostatic agent and maintained the blood clot inside the defect, Osteoconductive property, Biodegradability property,easily manipulated and handled.The most important findings from the obtained results revealed that these novel materials have the ability to accelerate bone healing specially at the early stages following implementation of the material. Part of the work was patented in Japan with patent number 2005-028066 and published in high impact factor scientific journals worldwide 1, 2,3, 4, 5 . In the presnt work the most new obtained data concerning biocompatibility and animal test will be presented