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Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction

H

Hams Hamed Abdelrahman

Status

Active, not recruiting

Conditions

Orbital Deformity

Treatments

Other: Uncoated titanium mesh
Other: Coated titanium mesh

Study type

Interventional

Funder types

Other

Identifiers

NCT05437731
Orbital_Reconstruction_2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

12 participants in 2 patient groups

Study group
Experimental group
Treatment:
Other: Coated titanium mesh
Control group
Active Comparator group
Treatment:
Other: Uncoated titanium mesh

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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