Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction

NCT05437731 | Unknown

• 1 other identifier: Orbital_Reconstruction_2022
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Orbital Deformity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Study group

EXPERIMENTAL

Other: Coated titanium mesh

Control group

ACTIVE COMPARATOR

Other: Uncoated titanium mesh

Interventions

Coated titanium mesh OTHER

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

Study group

Uncoated titanium mesh OTHER

patients will undergo reconstruction using the conventional uncoated titanium mesh.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

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

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 29, 2022
• Study Start: March 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: June 29, 2022

Record last verified: 2022-06

Locations

EG (1)