CMFlex® Bone Graft Accelerates Bone Formation and Contour Recovery in Multi-Centimeter Porcine Mandibular Defects: A Pilot Study

Abstract

Background: This study aimed to evaluate the performance of CMFlex® bone grafts in regenerating bone and restoring anatomical contour of large, irregular mandibular defects in a porcine model. Methods: Two adult (6-9 months of age) Yorkshire pigs with ramus defects (~12.7 cm2 area), treated with CMFlex® bone grafts (experimental) or left untreated (negative control). Animals were euthanized at 16- and 32-weeks post-implantation. Bone regeneration was assessed using CT, micro-CT, histology and mechanical testing to evaluate new bone formation, scaffold integration and contour restoration. Findings: CT imaging showed that CMFlex® grafts promoted significant bone formation, with substantial defect filling by 12-16 weeks. Two out of three defects successfully restored the jawline contour, while the third showed partial extrusion of new bone due to scaffold displacement. Micro-CT imaging confirmed scaffold material integrated within the bone and surrounding tissues at both time points. Histological analysis revealed active bone formation and maturation around and within the scaffold, along with evidence of scaffold degradation. Mechanical testing via nanoindentation showed no significant difference in Young’s Modulus between regenerated bone and native bone, suggesting comparable mechanical properties. Conclusion: This pilot study demonstrates that CMFlex® bone grafts can effectively regenerate bone in large (>5 cm2, which is ~25 mm diameter) mandibular defects and restore anatomical contour. These findings support the potential of CMFlex® as a promising scaffold-based solution for large-scale bone defects in human patients, warranting further clinical investigation.