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Enrolling By InvitationNCT06661785

Interlocking Polyetheretherketone Implants for Orbital Floor Reconstruction

Interlocking Polyetheretherketone Patient-Specific Implants for Orbital Floor Reconstruction

Status
Enrolling By Invitation
Phase
N/A
Study type
Interventional
Enrollment
22 (estimated)
Sponsor
Tanta University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

Patients with large orbital floor fracture were reconstructed with interlocking polyetheretherketone patient-specific implant and will be evaluated clinically and radiographically

Detailed description

Twenty two patients with large orbital floor fracture will be included in this study. Patients will be received, examined and managed at the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Full clinical examination and radiographic examination using multi axial C.T Scan for proper diagnosis and treatment planning. DICOM files will be imported into surgical planning software and used for fabrication of interlocking polyetheretherketone patient specific implant which will be ready for sterilization and insertion. After written informed consent from the patient, the surgery will be done under G.A, either infraorbital or transconjunctival incision will be done according to the case. Follow up: All patients will be examined clinically for hypoglobus, enophthalmos, ocular motility and diplopia during 2nd week, 1st month and 6 months \& radiographically for orbital volume immediately and 6 months postoperatively

Conditions

Interventions

TypeNameDescription
PROCEDURElarge orbital floor fractureTwenty two patients with large orbital floor fracture will be reconstructed with interlocking polyetheretherketone patient-specific implant

Timeline

Start date
2024-04-25
Primary completion
2024-07-25
Completion
2025-11-02
First posted
2024-10-28
Last updated
2025-09-04

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06661785. Inclusion in this directory is not an endorsement.