Custom-made 3D PEEK plates versus 3D titanium plates for mandibular angle fracture fixation: a randomized clinical trial

AIM: This study aimed to determine the clinical and radiographic efficacy of custom-made 3D PEEK plates in comparison with 3D titanium plates for the management of mandibular angle fractures. PATIENTS AND METHODS: Eighteen patients with recent mandibular angle fractures indicated for open reduction and internal fixation were randomly allocated into two groups. The study group (n = 9) underwent fixation with custom-made 3D PEEK plates, while the control group (n = 9) received prebent 3D titanium plates adapted on virtually reduced models. Primary outcomes were bite-force recovery and bone-density (Hounsfield units, HU) at the fracture line measured on CT immediately post-op and at 12 weeks. Secondary outcomes included operative time, occlusion, interfragmentary stability and wound healing. RESULTS: By the end of follow-up, Bite force increased significantly over time in both groups (p < 0.001) with no between-group differences at any time point. Mean bone density increased from 811.1 ± 68.2 HU to 1225.1 ± 111.7 HU in the PEEK group and from 809.0 ± 62.1 HU to 1248.3 ± 92.3 HU in the titanium group (p < 0.001); between-group differences were not significant. Operative time, occlusion outcomes and wound healing were similar between both groups. CONCLUSION: Custom-made 3D PEEK plates achieved comparable clinical, radiographic, and functional outcomes to 3D titanium plates, suggesting that PEEK is a viable alternative for mandibular angle fracture fixation. TRIAL REGISTRATION: Trial registered at (ClinicalTrials.gov/NCT07156812/2025-08-28).