The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant

Not Applicable

Completed

• Conditions: Orbital Fractures

• Registration Number: NCT06294535
• Lead Sponsor: Tanta University

Brief Summary

under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

Detailed Description

under GA, incision to access to orbital walls. complete reflection of orbital floor to be constructed then insertion of customized orbital implant of patient or insertion of titanium mrsh after adaption on the model and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

Study Timeline

• Study Start: 2023-12-11
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-05
• Primary Completion: 2024-05-18
• Study Completion: 2024-12-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-03
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• patient had fractured orbital walls suffering from enophthalmous, hypoglobus, diplopia

Exclusion Criteria

• systemic disease interfere with bone healing enophthamous less than 2 mm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
motility of eye	one month	using 9 gaze test to evaluate motility of eye
restoring the accurate position of eye	one month- six months	using exophthalmometer to measure enophthalmous
volume of orbit	one to six months	using CT scan to measure orbital volume pre and postoperative

Trial Locations

Locations (1)

Faculty of Dentistry, Tanta University; 🇪🇬 Tanta, Egypt