Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Orbital Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Study group

Group Type EXPERIMENTAL

Coated titanium mesh

Intervention Type OTHER

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

Control group

Group Type ACTIVE_COMPARATOR

Uncoated titanium mesh

Intervention Type OTHER

patients will undergo reconstruction using the conventional uncoated titanium mesh.

Interventions

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Coated titanium mesh

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

Intervention Type OTHER

Uncoated titanium mesh

patients will undergo reconstruction using the conventional uncoated titanium mesh.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No