Zygomaticomaxillary Complex FractureNCT05819372
Finite Element and One Point Fixation
A study testing Zygomaticomaxillary fracture repair in people with Zygomaticomaxillary Complex Fracture, run by Fayoum University at 1 site in Egypt.
Trial summary
A cone beam CT (CBCT) scan of the patient, will be used to create a 3D scanned image of ZMC 3D images will be introduced to finite element (FA)software to evaluate Stresses (MPa) and Life time (cycle) For each model and determine which point of fixation is the best After application this point of fixation on the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Zygomaticomaxillary Complex Fracture
- What is being tested?
- Zygomaticomaxillary fracture repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2023to 30 Jun 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fit to general anesthesia (GA)
- Isolated minimally displaced zygomaticomaxillary complex (ZMC) fracture
Who cannot join
- absence of other facial trauma, mandibular condylar fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Finite Element Analysis for Selection of Single Point Fixation in Zygomaticomaxillary Complex Fracture
- A cone beam CT (CBCT) scan of the patient, will be used to create a 3D scanned image of ZMC
- 3D images will be introduced to finite element (FA)software to evaluate Stresses (MPa) and Life time (cycle) For each model and determine which point of fixation is the best
- After application this point of fixation on the patient
- Finite element analysis will be done again to verify the previous results
- Conditions
- Zygomaticomaxillary Complex Fracture
- Being tested
- Zygomaticomaxillary fracture repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zygomaticomaxillary fracture repairProcedure or surgery
A cone beam CT (CBCT) scan of the patient will be used to create a 3D scanned image of zygomaticomaxillary complex fracture (ZMC)
- 3D images will be introduced to finite element (FA) software to evaluate Stresses (MPa), Micromotion (microns), and Life time (cycle) For each model and determine which point of fixation is the best
- After application this point of fixation on the patient
- Finite element analysis will be done again to verify the previous results
| Study group | Role | What they receive |
|---|---|---|
| finite arm | Experimental | Not described Receives: Procedure: Zygomaticomaxillary fracture repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stresses by megapascal (MPa)
stress on the plate will be measured for each point of application by finite element (FA) software
Measured: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start28 Feb 2023
- Primary completion1 Jun 2023
- Study completion30 Jun 2023
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 Zygomaticomaxillary Complex FractureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819372
- Sponsor's protocol ID
- R-OS-2-23-3
- Status last verified
- Dec 2023
- First submitted
- 24 Mar 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Refahee SM, Khalifa ME, Askar MG, Breshah MN. Role of finite element analysis for selection of single point fixation in zygomaticomaxillary complex fracture. BMC Oral Health. 2024 Jan 4;24(1):15. doi: 10.1186/s12903-023-03822-1.
PubMed 38178180
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Finite Element Analysis for Selection of Single Point Fixation in Zygomaticomaxillary Complex Fracture
- ClinicalTrials.gov ID
- NCT05819372
- Acronym / sponsor ID
- R-OS-2-23-3
- Conditions
- Zygomaticomaxillary Complex Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Apr 2023 (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.
- A cone beam CT (CBCT) scan of the patient, will be used to create a 3D scanned image of ZMC
- 3D images will be introduced to finite element (FA)software to evaluate Stresses (MPa) and Life time (cycle) For each model and determine which point of fixation is the best
- After application this point of fixation on the patient
- Finite element analysis will be done again to verify the previous results
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| finite arm | Experimental | Procedure: Zygomaticomaxillary fracture repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fit to general anesthesia (GA)
- Isolated minimally displaced zygomaticomaxillary complex (ZMC) fracture
Key exclusion criteria (1 listed)
- absence of other facial trauma, mandibular condylar 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 |
|---|---|---|
| Zygomaticomaxillary fracture repairA cone beam CT (CBCT) scan of the patient will be used to create a 3D scanned image of zygomaticomaxillary complex fracture (ZMC) * 3D images will be introduced to finite element (FA) software to evaluate Stresses (MPa), Micromotion (microns), and Life time (cycle) For each model and determine which point of fixation is the best * After application this point of fixation on the patient * Finite element analysis will be done again to verify the previous results | Procedure or surgery | finite arm |
Primary outcome
Stresses by megapascal (MPa)
Time frame: immediately after procedure
stress on the plate will be measured for each point of application by finite element (FA) software
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 2 Jan 2024.
- Derived from this study: PubMed 38178180Refahee SM, Khalifa ME, Askar MG, Breshah MN. Role of finite element analysis for selection of single point fixation in zygomaticomaxillary complex fracture. BMC Oral Health. 2024 Jan 4;24(1):15. doi: 10.1186/s12903-023-03822-1.
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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 Zygomaticomaxillary fracture repair in people with Zygomaticomaxillary Complex Fracture, run by Fayoum 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 2 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 2 Jan 2024. 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?
Stresses by megapascal (MPa) (time frame: immediately after procedure). 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 NCT05819372, 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 2 Jan 2024; AzTrials last refreshed its copy on 27 Oct 2026.