Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction (Randomized Controlled Clinical Trial)

Conditions
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Orbital Deformity

Intervention / Treatment
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* Other: Coated titanium mesh
* Other: Uncoated titanium mesh


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br> | Other: Coated titanium mesh<br>* patients will undergo repairing of defects or reconstruction using the titanium mesh coated with hydroxyapatite nanocrystals.<br>|
| Active Comparator: Control group<br> | Other: Uncoated titanium mesh<br>* patients will undergo reconstruction using the conventional uncoated titanium mesh.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in wound healing criteria | 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 | after 24-hours, one week, four weeks, and six weeks | 
| Change in bone density | All patients will be radiographically examined immediately and 3 months postoperatively using multi-slice computerized tomography (CT) using OnDemand3D software | at baseline and 3 months |