In vivo evaluation of bone regeneration behavior of novel β‐tricalcium phosphate/layered double hydroxide nanocomposite granule as bone graft substitutes

Abstract
This study was based on in vivo assessment of bone regeneration capacity of synthesized porous β-tricalcium phosphate (β-TCP) nanocomposite granules and aimed to explore the effects of fabricated β-TCP granules reinforced with layered double hydroxides (LDH) nanoclay compared to β-TCP granules, in terms of osteoconductivity and biodegradability. Granules with diameters of 2–3 mm were implanted into cavities drilled in rabbit distal femur and were left in situ for up to 3 months. The mechanical study demonstrated that the presence of LDH nanoparticles in β-TCP granules resulted in a significant increase in compressive modulus from 174.4 to 231.4 MPa, while the porosity was constant at 76%–80%. The results revealed that the obtained granules showed no cytotoxicity. In this study, x-ray radiographic, micro-computed tomography, and histological staining analysis were taken to evaluate the percentage of bone ingrowth and biodegradability of the porous granules. The results exhibited that both granules support bone regeneration and also the amount of new bone formation in the bone defect filled with both granules was almost six times higher than the empty defects. Although no significant difference in bone formation for two different granules was observed, a higher biodegradability was detected in β-TCP granules in comparison to β-TCP/LDH granules. Overall, the addition of LDH nanoclay (10%) enhanced the physicochemical and mechanical properties of β-TCP granules while it is biological and osteoconductity properties have been maintained and its biodegradation rate has been decreased.

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