Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Orbital Deformity
• Intervention / Treatment: Other: Coated titanium mesh; Other: Uncoated titanium mesh

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control group	Other: Uncoated titanium mesh; patients will undergo reconstruction using the conventional uncoated titanium mesh.
EXPERIMENTAL: Study group	Other: Coated titanium mesh; patients will undergo repairing of defects or reconstruction using the titanium mesh coated with hydroxyapatite nanocrystals.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2022
• Primary Completion (ANTICIPATED): October 30, 2022
• Study Completion (ANTICIPATED): October 30, 2022

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (ACTUAL): June 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: Orbital_Reconstruction_2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No