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

NCT06294535 | Completed

• 1 other identifier: 2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Orbital Fractures

Keywords

orbital wall reconstruction; prebent titanium mesh; patient specific implant; PEEK

Outcome Measures

Primary Outcomes (3)

• restoring the accurate position of eye

  using exophthalmometer to measure enophthalmous

  one month- six months

• motility of eye

  using 9 gaze test to evaluate motility of eye

  one month

• volume of orbit

  using CT scan to measure orbital volume pre and postoperative

  one to six months

Study Arms (2)

prebent titanium mesh

EXPERIMENTAL

reconstruction of fractured orbital walls with perbent titanium mesh

Device: reconstruction of orbital walls

customized titanium implant (patient specific implant)

EXPERIMENTAL

econstruction of fractured orbital walls with patient specific implant (customized titanium implant)

Device: reconstruction of orbital walls

Interventions

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.

customized titanium implant (patient specific implant); prebent titanium mesh

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, 3111, Egypt

Location

MeSH Terms

Conditions

Orbital Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• mona s sheta, lecturer

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patient select randomly from closed label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of oral and maxillofacial surgery department

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: December 11, 2023
• Primary Completion: May 18, 2024
• Study Completion: December 6, 2024
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

EG (1)