Clinical Trial of 3D-Printed PCL/β-TCP Composite Scaffold for Craniofacial Reconstruction in China

This study presents the first clinical application in China of a 3D-printed polycaprolactone (PCL)/ β-tricalcium phosphate(β-TCP) composite scaffold for craniofacial bone defect reconstruction. The clinical trial involved 2 patients with varying craniofacial defects who underwent reconstruction using customized PCL/β-TCP composite scaffolds. The scaffolds were designed based on CT imaging and fabricated through low-temperature 3D printing, ensuring personalized fit and biocompatibility. Postoperative follow-up demonstrated good scaffold integration, tissue ingrowth, and patient satisfaction without serious complications. This pioneering trial confirms the feasibility and safety of PCL/β-TCP composite scaffolds for craniofacial reconstruction, laying a foundation for broader clinical applications.