Accuracy and safety of in-house surgeon-designed three-dimensional-printed patient-specific implants for wafer-less Le Fort I osteotomy

Abstract

Objectives The design and fabrication of three-dimensional (3D)-printed patient-specific implants (PSIs) for orthognathic surgery are customarily outsourced to commercial companies. We propose a protocol of designing PSIs and surgical guides by orthognathic surgeons-in-charge instead for wafer-less Le Fort I osteotomy. The aim of this prospective study was to evaluate the accuracy and post-operative complications of PSIs that are designed in-house for Le Fort I osteotomy. Materials and methods The post-operative cone beam computer tomography (CBCT) model of the maxilla was superimposed to the virtual surgical planning to compare the discrepancies of pre-determined landmarks, lines, and principal axes between the two models. Twenty-five patients (12 males, 13 females) were included. Results The median linear deviations of the post-operative maxilla of the x, y, and z axes were 0.74 mm, 0.75 mm, and 0.72 mm, respectively. The deviations in the principal axes for pitch, yaw, and roll were 1.40 degrees, 0.90 degrees, and 0.60 degrees, respectively. There were no post-operative complications related to the PSIs in the follow-up period. Conclusions The 3D-printed PSIs designed in-house for wafer-less Le Fort I osteotomy are accurate and safe. Trial registration Clinical trial registration number: HKUCTR-2113. Date of registration: 29 July 2016.