Orbital VolumeNCT07879729
Comparison Study Between Custom Made and Ready Made Titanium Mesh in Orbital Floor Reconstruction
A study testing reconstruction of orbital floor with custom made mesh and reconstruction of orbital floor with ready made mesh in people with Orbital Volume and Orbital Floor Reconstruction, run by Alexandria University at 1 site in Egypt.
Trial summary
compare between Custom made titanium mesh and ready-made titanium mesh in reconstruction of orbital floor. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Orbital Volume, Orbital Floor Reconstruction
- What is being tested?
- reconstruction of orbital floor with custom made mesh and reconstruction of orbital floor with ready made mesh
- 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
- 1 Jan 2024to 18 Aug 2026
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with unilateral orbital floor fractures either isolated or combined with other facial fractures that require open reduction and internal fixation.
- Patients must be presented within 7 to 10 days from trauma.
- Patients suffering from one or more of the following features: diplopia, restricted eye movement, enophthalmos more than 2 mm and infraorbital anesthesia or paresthesia resulting from fracture.
- Both sexes are included, with an age range from 20 to 50 years.
Who cannot join
- Patient suffering from intra-ocular or global hematoma.
- Chronic systemic diseases such as uncontrolled diabetes, rheumatoid arthritis, immunocompromised status.
- Patients suffering from bilateral orbital fractures.
- Infected fracture site.
- Non displaced fracture.
- Comminuted fracture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Custom-Made Versus Ready-Made Titanium Mesh in Orbital Floor Reconstruction (A Randomized Controlled Clinical Trial)
compare between Custom made titanium mesh and ready-made titanium mesh in reconstruction of orbital floor.
- Conditions
- Orbital Volume, Orbital Floor Reconstruction
- Being tested
- reconstruction of orbital floor with custom made mesh, reconstruction of orbital floor with ready made mesh
- Keywords
- orbital floor reconstruction, custom-made mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reconstruction of orbital floor with custom made meshDevice
reconstruction of orbital floor with custom made mesh
reconstruction of orbital floor with ready made meshDevice
reconstruction of orbital floor with ready made mesh
| Study group | Role | What they receive |
|---|---|---|
| custom made titanium mesh | Experimental | Not described Receives: Device: reconstruction of orbital floor with custom made mesh |
| ready made titanium mesh | Active comparator | Not described Receives: Device: reconstruction of orbital floor with ready made mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
orbital volume
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Jan 2024
- Primary completion8 Jun 2026
- Study completion18 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital VolumeStudies of the same condition, open and under way.
- 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
- Model description
- randomized controlled clinical trial done on two groups. Study group treated with custom made mesh and the other treated with ready made mesh
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879729
- Sponsor's protocol ID
- 0945-08/2024
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Custom-Made Versus Ready-Made Titanium Mesh in Orbital Floor Reconstruction (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07879729
- Acronym / sponsor ID
- 0945-08/2024
- Conditions
- Orbital Volume, Orbital Floor Reconstruction
- Keywords
- orbital floor reconstruction, custom-made mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 19 Oct 2026 (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.
compare between Custom made titanium mesh and ready-made titanium mesh in reconstruction of orbital floor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled clinical trial done on two groups. Study group treated with custom made mesh and the other treated with ready made mesh
| Arm | Type | Receives |
|---|---|---|
| custom made titanium mesh | Experimental | Device: reconstruction of orbital floor with custom made mesh |
| ready made titanium mesh | Active comparator | Device: reconstruction of orbital floor with ready made mesh |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with unilateral orbital floor fractures either isolated or combined with other facial fractures that require open reduction and internal fixation.
- Patients must be presented within 7 to 10 days from trauma.
- Patients suffering from one or more of the following features: diplopia, restricted eye movement, enophthalmos more than 2 mm and infraorbital anesthesia or paresthesia resulting from fracture.
- Both sexes are included, with an age range from 20 to 50 years.
Key exclusion criteria (6 listed)
- Patient suffering from intra-ocular or global hematoma.
- Chronic systemic diseases such as uncontrolled diabetes, rheumatoid arthritis, immunocompromised status.
- Patients suffering from bilateral orbital fractures.
- Infected fracture site.
- Non displaced fracture.
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 floor with custom made meshreconstruction of orbital floor with custom made mesh | Device | custom made titanium mesh |
| reconstruction of orbital floor with ready made meshreconstruction of orbital floor with ready made mesh | Device | ready made titanium mesh |
Primary outcome
orbital volume
Time frame: 6 months
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 19 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 floor with custom made mesh and reconstruction of orbital floor with ready made mesh in people with Orbital Volume and Orbital Floor Reconstruction, run by Alexandria 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 4 inclusion and 6 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 19 Oct 2026. 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?
orbital volume (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.