Orbital Deformity
Conditions
Brief summary
Reconstruction of maxillofacial continuity defects has always been a challenging task for scientists and surgeons over the years. The main goal of the reconstruction of the maxillofacial region is to restore facial form, function, and full rehabilitation of occlusion and articulation. A refinement in surgical technique and methods of reconstruction has improved patients' quality of life. Aim of this study: Evaluation of titanium mesh coated with natural hydroxyapatite in orbital reconstruction.
Detailed description
Twelve patients having orbital defects will be selected. Six defects will be reconstructed using titanium mesh coated with natural hydroxyapatite nanocrystals (study group) and the other six will be treated with uncoated titanium mesh (control group). Patients will be evaluated clinically, then a radiographic follow-up will be performed immediately postoperatively and after three months to evaluate the bone density at the defect. Also, the coated and uncoated titanium mesh will be mechanically evaluated to compare the tensile strength of the two groups.
Interventions
OTHERCoated titanium mesh
patients will undergo repairing of defects or reconstruction using the titanium mesh coated with hydroxyapatite nanocrystals.
OTHERUncoated titanium mesh
patients will undergo reconstruction using the conventional uncoated titanium mesh.
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* All patients requiring reconstruction of acquired orbital defects using titanium mesh. * Both genders with age group ranging from 18-60 years old. * Limited size defects according to Cordeiro and Santamaria. * Isolated unilateral or bilateral orbital fractures or combined with other facial fractures. * Orbital reconstruction after removal of benign pathological lesions.
Exclusion criteria
* Infected fracture sites. * Chronic systemic diseases such as uncontrolled diabetes, rheumatoid arthritis, metabolic bone disease, immunocompromised status etc. * Defects requiring soft tissue reconstruction. * Patients suffering from burns. * Patients suffering from carcinomas and sarcomas in the oral cavity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in wound healing criteria | after 24-hours, one week, four weeks, and six weeks | The sutured wounds will be examined for signs and symptoms of infection. Yes: for presence of signs and sympotms No: for absence of signs and symptoms |
| Change in bone density | at baseline and 3 months | All patients will be radiographically examined immediately and 3 months postoperatively using multi-slice computerized tomography (CT) using OnDemand3D software |
Countries
Egypt
Outcome results
None listed