Precision of virtual surgical planning employing screw-holes locator and patient-specific implants versus conventional plate osteosynthesis for parasymphyseal mandibular fracture: a double-blinded randomized control trial.

BACKGROUND

Conventional plate osteosynthesis is the corner stone for management of displaced parasymphyseal mandibular fractures that necessitate open reduction and internal fixation (ORIF). Yet, the conventional workflow is labor-intensive, time consuming and limited by variable reduction accuracy as it relies solely on surgeon experience. Recently, various novel computer-guided techniques have been introduced for mandibular fracture repair, hiring surgical guides of diverse designs and strategies. These techniques served as a substitute for the conventional treatment modalities, offering improved precision, speed and reproducibility. Therefore, this randomized controlled trial (RCT) compares the overall precision of this distinct complete computer-guided virtual surgical planning (VSP) protocol as a whole, employing screw-holes locator and custom-made plates versus the conventional workflow for parasymphyseal mandibular fracture repair.

METHODS

Twenty-six cases presented with uncomminuted parasymphyseal mandibular fracture were enrolled and randomized into two groups. The interventional group underwent ORIF utilizing a screw-hole locator and custom-made plates, while the control group utilized ready-made mini-plates for ORIF. In both groups, virtual surgical planning of the fractured mandible was accomplished, creating a virtual reduced model by Mimics software aided by preoperative computer tomography (CT) scan. Then, three-dimensional model derived from the postoperative CT scan was superimposed onto the VSP reduced model. Linear deviations between predefined dental and bony landmarks to established anatomical planes were measured and underwent statistical analysis.

RESULTS

The actual postoperative mandibular model in the computer-guided group demonstrated negligible deviation from the VSP model. While the conventional group revealed considerably greater deviation. The average deviation of the bony landmarks was 0.044 ± 0.14 mm for the intervention group versus 0.69 ± 0.5 mm for the control group (p < 0.001). The average deviation of the dental landmarks was 0.04 ± 0.13 mm for the intervention group versus 0.47 ± 0.33 mm for the control group (p < 0.001). The average surgical time of the intervention group was 1.46 ± 0.18 h versus 1.80 ± 0.34 h for the control group (p = 0.004), with the intergroup difference being statistically significant.

CONCLUSIONS

The integration of screw-holes locator and patient-specific implants (PSI) have improved anatomical reduction precision, facilitated reestablishment of the patient's native occlusion and ensured more standardized reproducible outcomes, especially beneficial for less experienced surgeons.

TRIAL REGISTRATION: The study is a randomized control trial, registered at ClinicalTrials.gov Protocol Registration and Results System Receipt, NCT05647460, Data: 2022-12-05.