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°, 0.90°, and 0.60°, 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.

Clinical relevance: Its clinical outcomes and accuracy are comparable to commercial PSIs for orthognathic surgery.

Trial registration: Clinical trial registration number: HKUCTR-2113. Date of registration: 29 July 2016.

Keywords: Accuracy; Le Fort I osteotomy; Orthognathic surgery; Patient-specific implants; Virtual surgical planning.