Randomized Controlled Clinical Trial to Assess the Utility of Computer-Aided Intraoperative Navigation in Bimaxillary Orthognathic Surgery.

Abstract

Accurate application of the preoperative surgical plan in actual surgical settings is of paramount importance in orthognathic surgery. This randomized controlled clinical trial aimed to evaluate the accuracy of computer-aided intraoperative navigation (Ci-Navi) compared with that of conventional navigation methods in bimaxillary orthognathic surgery. Fifty-two patients were randomly divided into 2 groups. Group A (n = 26) patients underwent surgery assisted with Ci-Navi and group B (n = 26) patients underwent surgery assisted with conventional intraoperative navigation methods. During the operation, after LeFort I osteotomy, the mobile maxilla was repositioned to the designated position either using assistance from real-time Ci-Navi (group A) or using an intermediate splint (group B). Intra- and intergroup linear and angular differences between preoperative planning and postoperative outcomes were calculated. In group A, the overall mean linear difference was 0.79 mm (0.62 mm for the maxilla and 0.88 mm for the mandible) and the overall mean angular difference was 1.20°. In 23 cases, the difference from the upper incisor point to the Frankfort horizontal plane, midfacial sagittal plane, and coronal plane was less than 1 mm. In group B, the overall mean linear difference was 1.98 mm (1.76 mm for the maxilla and 2.02 mm for the mandible) and the overall mean angular difference was 2.08°. The difference from the upper incisor point to the Frankfort horizontal plane, midfacial sagittal plane, and coronal plane was less than 1 mm in 15 cases. This study demonstrates the utility of Ci-Navi is superior to the conventional methods in aiding the accurate repositioning of bony segments in bimaxillary orthognathic surgery.