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. 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. 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°, 0.90° and 0.60°, respectively. There were no post-operative complications related to the PSIs in the follow-up period. The 3D-printed PSIs designed in-house for wafer-less Le Fort I osteotomy are accurate and safe. Its clinical outcomes and accuracy are comparable to commercial PSIs for orthognathic surgery.
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