Assessment of a New Medical Device (Pirifix

Several medical devices (MDs) are used to assist surgeons in positioning the upper dental arch (UDA) during Le Fort I osteotomies (LFIOs). Some only allow holding, others only positioning. This study aimed to assess the accuracy of a new MD (Pirifix DICOM data were selected from patients who underwent surgical planning for LFIO between 27 July 2020 and 1 December 2022. Their anatomy was reproduced after segmentation, planning, and stereolithography in two models. Each model was assigned to one of two surgical groups: the control group (positioning by occlusal splint) and the Pirifix Twenty-one patients were selected. Forty-two anatomical models were 3D-printed. The mean difference compared to the planned and corrected positions was 0.69 mm for the control group and 0.84 mm for the Pirifix Pirifix