Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction

Hams Hamed Abdelrahman12 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Orbital Deformity

Interventions

Coated titanium meshOTHER

patients will undergo repairing of defects or reconstruction using the titanium mesh coated with hydroxyapatite nanocrystals.

Uncoated titanium meshOTHER

patients will undergo reconstruction using the conventional uncoated titanium mesh.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: at baseline and 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.