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).