In Vitro Biocompatibility Assessment and In Vivo Behavior of a New Osteoconductive βTCP Bone Substitute

Objective: Beta-tricalcium phosphate (beta TCP) granules (OsproLife) exhibit a pure crystalline phase and a rough microporous surface for promoting cell adhesion and microsized intragranule porosity for improving wettability and resorption necessary for bone regeneration. OsproLife is a fully resorbable, space-maintaining, and osteoconductive synthetic material for the filling of bone defects. To asses OsproLife properties, a similar synthetic biomaterial, already on the market, has been chosen as reference: Cerasorb has the same chemical composition, but different crystal structure, surface morphology, and granule size. The aim of this study is to compare the properties of OsproLife and Cerasorb. Methods: Chemical purity, composition and physical properties, in vitro cytotoxicity, and in vivo bone performance in a rabbit model were analyzed. beta TCP OsproLife granules (test) were compared with Cerasorb (control). Histological and mu CT analyses were performed at 6, 12, and 56 weeks after implantation. Results: beta TCP OsproLife and Cerasorb granules result to be both biocompatible and characterized by the same osteoconductivity and resorption rate. Conclusion: beta TCP OsproLife granules are a promising bone substitute for dental and orthopedic applications.