Back to resultsTitanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction
Primary Purpose
Orbital Deformity
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Coated titanium mesh
Uncoated titanium mesh
Sponsored by
About this trial
This is an interventional treatment trial for Orbital Deformity
Eligibility Criteria
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.
Sites / Locations
- Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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
Change in bone density
All patients will be radiographically examined immediately and 3 months postoperatively using multi-slice computerized tomography (CT) using OnDemand3D software
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05437731
Brief Title
Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction
Official Title
Evaluation of Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction (Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orbital Deformity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Coated titanium mesh
Intervention Description
patients will undergo repairing of defects or reconstruction using the titanium mesh coated with hydroxyapatite nanocrystals.
Intervention Type
Other
Intervention Name(s)
Uncoated titanium mesh
Intervention Description
patients will undergo reconstruction using the conventional uncoated titanium mesh.
Primary Outcome Measure Information:
Title
Change in wound healing criteria
Description
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
Title
Change in bone density
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
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Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction
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