Trials / Enrolling By Invitation
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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | large orbital floor fracture | Twenty 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.