Custom-designed scaffold for bone tissue engineering: an in vivo study

Critical-sized bone defects often cannot be fully healed with conventional grafting techniques. Bone tissue engineering offers alternative strategies using natural or synthetic materials to enhance bone regeneration. The objective of this study was to evaluate the biological performance of custom-designed 3D-printed scaffolds made from a novel composite material for potential orthopedic applications. All the laboratory animal procedures in this study were approved by the Italian Ministry of Health (authorization number 224/2022-PR). Twenty SpragueDawley rats were used, each receiving two critical-sized calvarial defects: one treated with the scaffold and one left untreated as a control. Animals were euthanized at four and eight weeks for micro-CT and histological analyses. Results of both analyses showed significantly greater bone regeneration in the scaffold-treated defects compared to controls at both time points (p < 0.05). Histological evaluation also revealed significantly lower inflammation and hemorrhage in the scaffold group (p < 0.05). These findings indicate that the composite scaffold is biocompatible and promotes osteogenesis, suggesting its potential as an alternative bone substitute. Further studies are needed before clinical application.