Purpose To assess whether virtual simulations of the projection of the soft tissues of the face after class II bimaxillary orthognathic surgery, generated from 3D reconstruction of preoperative computed tomography (CT) scans, differed significantly from the actual soft tissue profile obtained in the late postoperative period (beyond 6 months). Secondarily, to validate the accuracy of a free, open-source software suite for virtual soft tissue planning in orthognathic surgery. Methods Helical CT scans were obtained pre- and postoperatively from 16 patients with Angle class II malocclusion who underwent bimaxillary orthognathic surgery. A comparative study between soft tissue meshes constructed for surgical simulation (M1) and the actual meshes obtained from postoperative scans (M2) was then performed. To establish the accuracy of 3D facial soft tissue simulation in a free and open-source software suite (OrtogOnBlender-OOB), 17 predetermined anatomic landmarks were measured in M1 and M2 scans after alignment of cranial structures. Results The mean error between preoperative simulations and actual postoperative findings was < 2 mm for all anthropometric landmarks. The overall average error for the facial soft tissues was 1.07 mm. Conclusion Comparison between preoperative simulation (M1) and actual postoperative findings (M2) showed clinically relevant ability of the method to reproduce actual surgical movement reliably (< 2-mm error). OOB is capable of accurate soft tissue planning for orthognathic surgery, but mesh deformation methods still require improvement. Trial registration RBR-88jff9 . Retrospectively registered at Brazilian Registry of Clinical trials-ReBec ( http://www.ensaiosclinicos.gov.br ) May 06, 2020.
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