Fracture Mandible
Conditions
Keywords
titanium angle fracture mandible
Brief summary
Is patient specific customized computer assisted 3D PEEK plates more superior to 3D titanium plate in fixation of mandibular angle fractures?
Detailed description
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.
Interventions
DEVICEPatient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws.
Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws.
DEVICEConventional 3D titanium plates
Conventional 3D titanium plates used for fixation of mandibular angle fractures with titanium screws.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
Two groups of patients were assigned in this randomized clinical trial. Group I (Study group): Patients were treated using patient-specific customized 3D PEEK plates for fixation of mandibular angle fractures. Group II (Control group): Patients were treated using conventional 3D titanium plates for fixation of mandibular angle fractures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative occlusion stability(binary: yes/no) | 1 week, 1 month, and 6 months postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Condylar seating (binary: yes/no) | 1 week, 1 month, and 6 months postoperatively | Condylar seating was assessed radiographically using standardized panoramic radiographs. The position of the mandibular condyle within the glenoid fossa was evaluated. Proper condylar seating was defined as a normal anatomical position without displacement. Any deviation from the normal position was recorded as improper. |
| Postoperative infection (binary: yes/no) | 1 week, 1 month, and 6 months postoperatively | Postoperative infection was recorded as present or absent. |
| Wound dehiscence (binary: yes/no) | 1 week, 1 month, and 6 months postoperatively | Wound dehiscence was recorded as present or absent. |
| Need for second surgical intervention ( binary: yes/no) | 1 week, 1 month, and 6 months postoperatively | Need for second surgery was recorded as yes or no. |
Countries
Egypt
Contacts
STUDY_CHAIRHamida Refaae, PhD
Cairo University
Outcome results
None listed