Orbital FracturesNCT06294535
The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant
A study testing reconstruction of orbital walls in people with Orbital Fractures, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Orbital Fractures
- What is being tested?
- reconstruction of orbital walls
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Dec 2023to 6 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patient had fractured orbital walls suffering from enophthalmous, hypoglobus, diplopia
Who cannot join
- systemic disease interfere with bone healing enophthamous less than 2 mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant : A Prospective Study
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.
Read the 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.
- Conditions
- Orbital Fractures
- Being tested
- reconstruction of orbital walls
- Keywords
- orbital wall reconstruction, prebent titanium mesh, patient specific implant, PEEK
- Medical subject headings
- Orbital Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reconstruction of orbital wallsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| prebent titanium mesh | Experimental | reconstruction of fractured orbital walls with perbent titanium mesh Receives: Device: reconstruction of orbital walls |
| customized titanium implant (patient specific implant) | Experimental | econstruction of fractured orbital walls with patient specific implant (customized titanium implant) Receives: Device: reconstruction of orbital walls |
What is being measured
The primary outcome is the main question the study is designed to answer.
restoring the accurate position of eye
using exophthalmometer to measure enophthalmous
Measured: one month- six months
motility of eye
using 9 gaze test to evaluate motility of eye
Measured: one month
volume of orbit
using CT scan to measure orbital volume pre and postoperative
Measured: one to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start11 Dec 2023
- Primary completion18 May 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orbital FracturesStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mona samy sheta, Tanta University
- Investigators
- mona s sheta, lecturer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294535
- Sponsor's protocol ID
- 2024
- Status last verified
- May 2025
- First submitted
- 28 Feb 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sheta MS, Elsaadany WH. The accuracy of reconstruction of orbital wall fractures using prebent mesh versus patient specific implants: a randomized clinical trial. BMC Oral Health. 2025 Nov 1;25(1):1719. doi: 10.1186/s12903-025-07082-z.
PubMed 41176602
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant : A Prospective Study
- ClinicalTrials.gov ID
- NCT06294535
- Acronym / sponsor ID
- 2024
- Conditions
- Orbital Fractures
- Keywords
- orbital wall reconstruction, prebent titanium mesh, patient specific implant, PEEK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 18 May 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prebent titanium mesh | Experimental | Device: reconstruction of orbital wallsreconstruction of fractured orbital walls with perbent titanium mesh |
| customized titanium implant (patient specific implant) | Experimental | Device: reconstruction of orbital wallseconstruction of fractured orbital walls with patient specific implant (customized titanium implant) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patient had fractured orbital walls suffering from enophthalmous, hypoglobus, diplopia
Key exclusion criteria (1 listed)
- systemic disease interfere with bone healing enophthamous less than 2 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reconstruction of orbital wallsunder 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. | Device | customized titanium implant (patient specific implant), prebent titanium mesh |
Primary outcome
restoring the accurate position of eye
Time frame: one month- six months
using exophthalmometer to measure enophthalmous
motility of eye
Time frame: one month
using 9 gaze test to evaluate motility of eye
volume of orbit
Time frame: one to six months
using CT scan to measure orbital volume pre and postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Derived from this study: PubMed 41176602Sheta MS, Elsaadany WH. The accuracy of reconstruction of orbital wall fractures using prebent mesh versus patient specific implants: a randomized clinical trial. BMC Oral Health. 2025 Nov 1;25(1):1719. doi: 10.1186/s12903-025-07082-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mona s sheta, lecturer principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reconstruction of orbital walls in people with Orbital Fractures, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
restoring the accurate position of eye (time frame: one month- six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06294535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.