Physico/chemical characterization and preliminary human histology assessment of a β-TCP particulate material for bone augmentation

This study aimed to physico/chemically characterize and evaluate the in vivo performance of a β-TCP particulate grafting material. SEM/TEM, and EDS and XPS were used for morphology and chemistry assessment, respectively. FTIR was used to determine Ca-P phases characteristic bands. Rietveld refinement/XRD spectra was performed for secondary phase detection. Particle size distribution and specific surface were assessed by a scattering-laser based technique and BET, respectively. Mercury porosimetry was employed to determine pore-size distribution. For in vivo evaluation, the grafting material was used in 12 patients' sinus lifts, and biopsies were obtained at post-operative times of 3, 6, and 9 months. SEM/TEM revealed multigrained particles with interconnected pores. EDS showed Ca, P, and O, with stoichiometry close to theoretical values. XRD/Rietveld showed that the material presented crystalline β-TCP with ~ 9% β-Ca₂P₂O₇ secondary phase. FTIR did not detect the presence of bands related to α-TCP. Human histologic assessment showed that newly formed bone was present at 3 months, and degrees of bone organization increased as time elapsed in vivo. Human histology showed that the material is suitable for bone regeneration in a maxillofacial complex region.