Novel chitosan-based bone substitute. A summary of in vitro and in vivo evaluation

Author(s): Witold Bojar, Tomasz Ciach, Sylwia Flis, Micha? Sza?wi?ski, Maciej Jagielak

Backgorund: Composite bone substitute materials have been raising more interest as an alternative for autologous transplants and pure xenogenic materials in oral surgery for last few years. These not immunogenic and completely resorbable biomaterials may become the basis for complete and predictable guided bone regeneration. In the majority of cases the deciding factor is ease of application of the material by a surgeon.

Objectives: The main objective of our project was to design and fabricate an osteoconductive, injectable and well tolerated by human tissues biomaterial for guided bone regeneration.

Materials and methods: For this purpose, a self-setting composite consisting of chitosan/tricalcium phosphate microparticles and sodium alginate was formulated. The obtained material was characterized as far as microsphere, agglomerates morphology and microstructure are concerned. Physical properties relating to setting time and mechanical properties were precisely investigated. Our material was evaluated according to EN ISO 10993 Biological evaluation of medical devices. Then, the implantation tests on small and big animal model were performed. Results: The tested material showed high degree of cytocompatibility, fulfilled the requirements of the International Standards, confirmed its osteoconductivity after implantation and seems to be a “user friendly” material for oral, orthopedics and neurosurgeons.

Conclusions: On the basis of positive in vitro and in vivo test results an attempt at introducing new biotechnology was made.