From Bench to Bedside: A Pilot Clinical Study on NANOTEX Bone Graft for Fibula Onlay Augmentation in Mandibular...

Mandibular continuity defects following tumor resection or trauma present significant reconstructive challenges, particularly for subsequent dental rehabilitation. While the fibula free flap remains the gold standard, its limited vertical height often necessitates augmentation. This prospective, single-center, non-randomized pilot clinical trial evaluated the safety and efficacy of a novel silica-coated nanohydroxyapatite-gelatin/PLLA scaffold (NANOTEX), manufactured under GMP conditions and ISO 13485-certified quality standards, for vertical augmentation over fibula flaps in ten patients undergoing segmental mandibulectomy for benign jaw tumors. Customized NANOTEX scaffolds were placed intraoperatively, and safety (inflammation, wound dehiscence, infection laboratory parameters) and efficacy (bone height gain, radiodensity, bone union, and implant stability) were assessed at baseline, 3 and 6 months. No scaffold-related serious adverse events were observed; mild to moderate inflammation and wound dehiscence were transient. Significant bone regeneration was achieved, with a mean vertical gain of 26.99% at 6 months, which was higher in regions contacting the native mandible (32.58%) compared to non-contact areas (25.02%). Radiodensity progressed from cancellous to cortical levels, and implant placement at 6 months demonstrated high stability in 88.6% of cases (ISQ > 70). Overall, NANOTEX was safe and promoted vertical bone regeneration, highlighting its translational potential for mandibular reconstruction.