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OpenTrials
Completed

NCT Number: NCT06294535

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

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tanta University

Tanta, 3111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reconstruction of orbital walls

Device

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.

Primary outcomes

  1. restoring the accurate position of eye

    Time frame: one month- six months

    using exophthalmometer to measure enophthalmous

  2. motility of eye

    Time frame: one month

    using 9 gaze test to evaluate motility of eye

  3. volume of orbit

    Time frame: one to six months

    using CT scan to measure orbital volume pre and postoperative

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant : A Prospective Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 5, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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