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

OBJECTIVE: Beta-tricalcium phosphate (ßTCP) 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. ßTCP OsproLife granules (test) were compared with Cerasorb (control). Histological and µCT analyses were performed at 6, 12, and 56 weeks after implantation. RESULTS: ßTCP OsproLife and Cerasorb granules result to be both biocompatible and characterized by the same osteoconductivity and resorption rate. CONCLUSION: ßTCP OsproLife granules are a promising bone substitute for dental and orthopedic applications.

Characterization and cytocompatibility of a new injectable multiphasic bone substitute based on a combination of polysaccharide gel-coated OSPROLIFE(®) HA/TTCP granules and bone marrow concentrate.

The purpose of this study was to examine the in vitro cytocompatibility of a novel injectable multiphasic bone substitute (MBS) based on polysaccharide gel-coated OSPROLIFE(®) hydroxyapatite (HA)/tetracalcium phosphate (TTCP) granules combined with bone marrow concentrate (BMC). Polysaccharide gel-coated granules loaded in syringe were combined with BMC diluted in ionic crosslinking solution. The product was then maintained in culture to investigate the cytocompatibility, distribution, and osteogenic differentiation function of cells contained in the BMC. The in vitro cytocompatibility was assessed after 0, 24, and 96 h from the injectable MBS preparation using the LIVE/DEAD(®) staining kit. The results highlighted that cells remained viable after combination with the polysaccharide gel-coated granules; also, viability was maintained over time. The distribution of the cells in the product, observed using confocal microscopy, showed viable cells immersed in the polysaccharide gel formed between the granules after ionic crosslinking. The mesenchymal stromal cells (MSC) contained in the injectable MBS, the basic elements for bone tissue regeneration, were able to differentiate toward osteoblasts, producing an osteogenic matrix as evidenced by alizarin red-s (AR-S) staining. In conclusion, we found that the injectable MBS may have the potential to be used as a bone substitute by applying a "one-step" procedure in bone tissue engineering applications. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 894-902, 2016.

A new HA/TTCP material for bone augmentation: an in vivo histological pilot study in primates sinus grafting.

OBJECTIVE: Synthetic calcium phosphate bone substitutes are widely used in sinus graft procedures due to their osteoconductive and biocompatible properties. Hydroxyapatite (HA), beta-tricalcium phosphate (ß-TCP), and HA/ß-TCP composite are the most applied materials. The aim of this study was to propose a new mineralogical formulation, HA/tetracalcium phosphate (TTCP), as biomaterial for bone regeneration in the maxillary sinus. METHODS: Sinus grafts were performed by using granules of a HA/TTCP blend and a collagen membrane. Bone response at time points of 14 and 17 weeks was histologically evaluated. RESULTS: After 14 weeks of healing, histomorphometric analysis showed the formation of new bone trabeculae among HA/TTCP granules. After 17 weeks, the bone trabeculae were thicker and HA/TTCP granules were still present. Histomorphometric analysis revealed a bone graft contact (BGC) of 64%. CONCLUSIONS: After 17 weeks from implantation, HA/TTCP synthetic bone graft performed very well as osteoconductive material: BGC was found very high, and bone volume and vital bone showed an ideal bone density for implant placement. HA/TTCP granules are accounted for to accelerate new bone formation and to reduce the time needed for the graft healing, thus achieving high quantity of the new bone formed.