# Assessment of a New Medical Device (PirifixTM) for Positioning and Maintaining the Upper Dental Arch during Le Fort I Osteotomy

## TL;DR

This study evaluates a new medical device called PirifixTM for positioning the upper dental arch during a specific surgical procedure, showing promising results compared to traditional methods.

## Contribution

The novel contribution is the introduction and assessment of PirifixTM, a medical device that combines positioning and holding functions during Le Fort I osteotomies.

## Key findings

- PirifixTM showed a mean difference of 0.84 mm compared to the planned position.
- The control group had a mean difference of 0.69 mm, with a statistically significant difference (p = 0.036).

## Abstract

Introduction: 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 (PirifixTM) coupling these two functions during LFIO on 3D-printed models. Materials and Methods: 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 PirifixTM group. Each patient’s model was planned with the objective of horizontalizing and recentering the UDA. After positioning, models were digitalized using Einscan Pro 2X and compared to the planned model with CloudCompare. The statistical analysis was performed using the Wilcoxon Mann–Whitney test. The result was considered significant if the p-value was less than 0.05. Results: 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 PirifixTM group (p = 0.036). Conclusion: PirifixTM may be a new alternative to available MDs. Further investigations are needed to describe the relationship between the device and facial soft tissues.