Is patient specific customized computer assisted 3D PEEK plates more superior to 3D titanium plate in fixation of mandibular angle fractures?

Open Reduction Internal fixation (ORIF) of mandibular angle fractures using titanium plating systems had several drawbacks including sepsis with subsequent wound dehiscence and the need for 2nd surgery which is attributed to bone loss as a result of the elevated modulus of elasticity of titanium hardware. Accordingly, attempts were made to overcome problems encountered with the titanium plating system. In this study, custom made PEEK 3D plates will be used in ORIF of mandibular angle fractures. The main beneficial property of PEEK material is its lower modulus of elasticity that is close to that of living bone with subsequent elimination of the problem of stress shielding phenomenon encountered with titanium plating system. PEEK material has other advantages including biocompatibility, mechanical strength, durability, resistance to high degree of temperature without dimensional alteration.

Inclusion Criteria:

1. Patients with mandibular angle fractures indicated for open reduction and internal fixation (ORIF).
2. Patients aged 18 years and above.
3. Both male and female patients.
4. Patients medically fit for surgery under general anesthesia.
5. Patients providing informed consent.

Exclusion Criteria:

1. Patients with pathological fractures.
2. Patients with comminuted fractures not suitable for fixation with plates.
3. Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
4. Patients with a history of previous mandibular surgery in the same region.
5. Patients who are unable or unwilling to comply with follow-up.

Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations.

This study is an open-label randomized clinical trial. Due to the nature of the surgical intervention, blinding of participants and surgeons was not feasible.