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

초록

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 com-posite 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 re-sponses, 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 expo -sure 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 pa-tients with craniofacial defects were included. The clinical outcome was favorable in terms of compli-cations, 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 1/4 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.(c) 2023 The Authors. Published by Elsevier Ltd on behalf of European Association for Cranio-Maxillo-Facial Surgery. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).

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