Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction

NCT06369129 | Recruiting DMC

• 1 other identifier: CEBD-CU-2024-06-16
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures .

Conditions

Blow-Out Fractures; Orbital Fractures; Orbital Floor Fracture; Orbital Trauma

Outcome Measures

Primary Outcomes (1)

• Orbital Volume

  will be measured with CT scan in mm3

  immediately post operative

Secondary Outcomes (3)

• Accuracy of the patient specific implant in the orbital floor reconstruction

  immediately post operative

• Cost effectiveness

  through study completion, an average of 1 year

• Patient satisfaction

  through study completion, an average of 1 year

Study Arms (2)

Orbital floor reconstruction with Patient Specific Zirconia Implant

EXPERIMENTAL

Orbital floor reconstruction with Patient Specific Zirconia Implant will be done

Procedure: Orbital floor reconstruction with Patient Specific Zirconia Implant

Orbital floor reconstruction with Patient Specific Titanium Implant

ACTIVE COMPARATOR

Orbital floor reconstruction with Patient Specific Titanium Implant will be done.

Procedure: Orbital floor reconstruction with Patient Specific Titanium Implant

Interventions

Orbital floor reconstruction with Patient Specific Zirconia Implant PROCEDURE

Orbital floor reconstruction with Patient Specific Zirconia Implant will be done

Orbital floor reconstruction with Patient Specific Zirconia Implant

Orbital floor reconstruction with Patient Specific Titanium Implant PROCEDURE

Orbital floor reconstruction with Patient Specific Titanium Implant will be done

Orbital floor reconstruction with Patient Specific Titanium Implant

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with blow out fracture isolated and / or combined with other fracture.
• Age group: from 18 to 60 years old
• No sex predilection
• Patients with no contraindications to surgical intervention.
• Patients willing for the surgical procedure and follow-up, with an informed consent.

You may not qualify if:

• Medically compromised patients.
• Patients with history of previous orbital reconstruction surgery.
• Uncooperative patients.
• Patients with systemic contraindication to general anesthesia.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11511, Egypt

RECRUITING

MeSH Terms

Conditions

Orbital Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• OLA A. ELMORSY, PHD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

OLA A. ELMORSY, PHD

CONTACT

00201141234877; dr.ola.elmorsy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: A randomized clinical trial. * Parallel group study. * A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University . * Equal randomization : participants with equal probabilities for intervention. * Positive controlled : Both groups receiving treatment.

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 16, 2024
• Study Start: April 6, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)