Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction

Not Applicable

• Conditions: Orbital Deformity
• Interventions: Other: Uncoated titanium mesh; Other: Coated titanium mesh

• Registration Number: NCT05437731
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Study Timeline

• Study Start: 2022-03-01
• Status Verified: 2022-06
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Last Update Submitted: 2022-06-27
• Study First Posted: 2022-06-29
• Last Update Posted: 2022-06-29
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Uncoated titanium mesh	-
Study group	Coated titanium mesh	-

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt