Comparative Evaluation of 3D-printed (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle

N/ACompletedNCT07520227

Cairo University22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fracture Mandible

Interventions

Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws.DEVICE

Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws.

Conventional 3D titanium platesDEVICE

Conventional 3D titanium plates used for fixation of mandibular angle fractures with titanium screws.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Osama Abdelaziz Abdelreheem

Cairo, Egypt

Outcomes

Primary Outcomes

Postoperative occlusion stability(binary: yes/no)

Occlusal stability was recorded as stable or unstable. Occlusal stability was assessed clinically by evaluating the intercuspation between maxillary and mandibular teeth. Proper occlusion was defined as normal intercuspation without premature contacts or occlusal discrepancies. Any deviation, including open bite or malocclusion, was recorded during follow-up.