A Quantitative and Qualitative Clinical Validation of Soft Tissue Simulation for Orthognathic Surgery Planning.

The purpose of this study was to perform a quantitative and qualitative validation of a soft tissue simulation pipeline for orthognathic surgery planning, necessary for clinical use. Simulation results were retrospectively obtained in 10 patients who underwent orthognathic surgery. Quantitatively, error was measured at 9 anatomical landmarks for each patient and different types of comparative analysis were performed considering two mesh resolutions, clinically accepted error, simulation time and error measured by means of percentage of the whole surface. Qualitatively, evaluation and binary questions were asked to two surgeons, both before and after seeing the actual surgical outcome, and their answers were compared. Finally, the quantitative and qualitative results were compared to check if these two types of validation are correlated. The quantitative results were accurate, with greater errors corresponding to gonions and lower lip. Qualitatively, surgeons answered similarly mostly and their evaluations improved when seeing the actual outcome of the surgery. The quantitative validation was not correlated to the qualitative validation. In this study, quantitative and qualitative validations were performed and compared, and the need to carry out both types of analysis in validation studies of soft tissue simulation software for orthognathic surgery planning was proved.