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

Not Applicable
Completed
Conditions
Orbital Fractures
Interventions
Device: reconstruction of orbital walls
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.

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
Arm && Interventions
GroupInterventionDescription
prebent titanium meshreconstruction of orbital wallsreconstruction of fractured orbital walls with perbent titanium mesh
customized titanium implant (patient specific implant)reconstruction of orbital wallseconstruction of fractured orbital walls with patient specific implant (customized titanium implant)
Primary Outcome Measures
NameTimeMethod
motility of eyeone month

using 9 gaze test to evaluate motility of eye

restoring the accurate position of eyeone month- six months

using exophthalmometer to measure enophthalmous

volume of orbitone to six months

using CT scan to measure orbital volume pre and postoperative

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Faculty of Dentistry, Tanta University

🇪🇬

Tanta, Egypt

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