Titanium Mesh Coated With Natural Hydroxyapatite Nanocrys... | NCT05437731

Studies
Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction

NCT05437731

Sponsor

Hams Hamed Abdelrahman

Status

Unknown status

Last Update Posted

Jun 29, 2022Actual

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Orbital Deformity

Interventions

Coated titanium mesh
Uncoated titanium mesh

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Oct 30, 2022Estimated

Completion Date

Oct 30, 2022Estimated

First Submitted Date

Jun 27, 2022

First Submission Date that Met QC Criteria

Jun 27, 2022

First Posted Date

Jun 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2022

Last Update Posted Date

Jun 29, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria UniversitySponsor-Investigator

Lead Sponsor

Hams Hamed AbdelrahmanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental		Other: Coated titanium mesh
Control group	Active Comparator		Other: Uncoated titanium mesh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coated titanium mesh	Other	patients will undergo repairing of defects or reconstruction using the titanium mesh coated with hydroxyapatite nanocrystals.	Study group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University		Alexandria			Egypt