Complications arising from clinical application of composite polycaprolactone/bioactive glass ceramic implants for craniofacial reconstruction: A prospective study

Abstract

This study aimed to demonstrate the in vitro performance of a novel polymer-ceramic composite incorporating polycaprolactone (PCL) and bioactive glass (BGS-7), and investigate its clinical outcomes in craniofacial reconstruction. After preparation of the material, the biochemical properties of the composite PCL/BGS-7 implant were tested to evaluate apatite formation in simulated body fluid (SBF). Changes in the implant surface after soaking in the SBF were determined using field-emission scanning electron microscopy. For clinical application of the implant, patients with craniofacial defects were prospectively enrolled to receive three-dimensional (3D)-printed PCL/BGS-7 implants. Clinical outcomes were investigated by reviewing postoperative complications, including wound problems, allergic responses, hematoma, seroma, implant displacement, and bone union. The accuracy of reconstruction was assessed by measuring the surface error between the reconstructed and mirrored models. Upon exposure of the PCL/BGS-7 implant to SBF, apatite particles were actively developed on the surface of the PCL/BGS-7 sample, showing favorable bone-binding capacity. Regarding the clinical application, seven patients with craniofacial defects were included. The clinical outcome was favorable in terms of complications, except in one patient, who presented with delayed wound healing due to previous irradiation. The patients showed improvements in symmetry, with a significant change in mean ± SD surface error between preoperative (5 ± 3 mm) and postoperative (1.5 ± 0.65 mm) status (p = 0.018). Wthin the limitations of the study it seems that the PCL/BGS-7 implants might be a relevant option for repairing craniofacial bone defects, owing to its favorable bone-binding property and clinical safety, with few complications.