Zygomaticomaxillary Complex (ZMC) FracturesNCT07788885
Evaluation of Custom-Made Plates in the Treatment of Zygomaticomaxillary Complex (ZMC) Fractures.
A study testing Custom-made 3D-printed titanium plate in people with Zygomaticomaxillary Complex (ZMC) Fractures, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This prospective, single-arm clinical trial evaluated the clinical and radiographic outcomes of custom-made, 3D-printed titanium plates in the surgical treatment of unilateral zygomaticomaxillary complex (ZMC) fractures. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Zygomaticomaxillary Complex (ZMC) Fractures
- What is being tested?
- Custom-made 3D-printed titanium plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 6 Jun 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years. Unilateral ZMC fractures indicated for open reduction and internal fixation (ORIF).
- Medically fit for general anesthesia. Trauma occurring within 10 days. Commitment to 3 months of follow-up.
Who cannot join
- Exclusion Criteria Bilateral or panfacial fractures. Pathological fractures or previous ZMC surgery. Systemic disease affecting bone healing. Patients refusing consent. Sex: All
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Oral and Maxillofacial Surgery, Faculty of Dental Medicine, Al-Azhar University - Assiut Branch
Asyut, Assuit, 71511
About this study
Official title: Evaluation of Custom-Made Plates in the Treatment of Zygomaticomaxillary Complex (ZMC) Fractures
This prospective, single-arm clinical trial evaluated the clinical and radiographic outcomes of custom-made, 3D-printed titanium plates in the surgical treatment of unilateral zygomaticomaxillary complex (ZMC) fractures. The study assessed the accuracy of anatomical reduction, postoperative functional and esthetic outcomes, surgical efficiency, patient satisfaction, and postoperative complications.
Read the detailed description
Patients with unilateral ZMC fractures requiring open reduction and internal fixation underwent virtual surgical planning based on preoperative CT imaging. Custom-made 3D-printed titanium plates were designed according to the patient's anatomy and used for fracture fixation. Clinical and radiographic outcomes were assessed postoperatively at 1 week, 1 month, and 3 months.
- Being tested
- Custom-made 3D-printed titanium plate
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-made 3D-printed titanium plateDevice
Custom-made 3D-printed titanium plates designed through virtual surgical planning based on preoperative CT imaging. The healthy side was mirrored to assist in virtual reconstruction and plate design. The plates were fabricated from biocompatible titanium and sterilized before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Custom-Made 3D-Printed Titanium Plate | Experimental | Custom-made 3D-printed titanium plates designed through virtual surgical planning based on preoperative CT imaging. The healthy side was mirrored to assist in virtual reconstruction and plate design. The plates were fabricated from biocompatible titanium and sterilized before surgery. Receives: Device: Custom-made 3D-printed titanium plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Anatomical Reduction
Accuracy of anatomical reduction assessed by comparing postoperative CT findings with the preoperative virtual surgical plan.
Measured: Immediate postoperative assessment and 3 months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Oct 2025
- Primary completion6 Jun 2026
- Study completion6 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygomaticomaxillary Complex (ZMC) FracturesStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants underwent surgical fixation of unilateral ZMC fractures using custom-made 3D-printed titanium plates.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abu Alhassan Refaei Saied Mahmoud, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788885
- Sponsor's protocol ID
- Evaluation of Custom-Made Plat
- Status last verified
- Oct 2025
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Custom-Made Plates in the Treatment of Zygomaticomaxillary Complex (ZMC) Fractures
- ClinicalTrials.gov ID
- NCT07788885
- Acronym / sponsor ID
- Evaluation of Custom-Made Plat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 6 Jun 2026 (actual)
- Study completion
- 6 Jun 2026 (actual)
- First posted
- 27 Aug 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.
This prospective, single-arm clinical trial evaluated the clinical and radiographic outcomes of custom-made, 3D-printed titanium plates in the surgical treatment of unilateral zygomaticomaxillary complex (ZMC) fractures. The study assessed the accuracy of anatomical reduction, postoperative functional and esthetic outcomes, surgical efficiency, patient satisfaction, and postoperative complications.
Detailed description
Patients with unilateral ZMC fractures requiring open reduction and internal fixation underwent virtual surgical planning based on preoperative CT imaging. Custom-made 3D-printed titanium plates were designed according to the patient's anatomy and used for fracture fixation. Clinical and radiographic outcomes were assessed postoperatively at 1 week, 1 month, and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants underwent surgical fixation of unilateral ZMC fractures using custom-made 3D-printed titanium plates.
| Arm | Type | Receives |
|---|---|---|
| Custom-Made 3D-Printed Titanium Plate | Experimental | Device: Custom-made 3D-printed titanium plateCustom-made 3D-printed titanium plates designed through virtual surgical planning based on preoperative CT imaging. The healthy side was mirrored to assist in virtual reconstruction and plate design. The plates were fabricated from biocompatible titanium and sterilized before surgery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-50 years. Unilateral ZMC fractures indicated for open reduction and internal fixation (ORIF).
- Medically fit for general anesthesia. Trauma occurring within 10 days. Commitment to 3 months of follow-up.
Key exclusion criteria (1 listed)
- Exclusion Criteria Bilateral or panfacial fractures. Pathological fractures or previous ZMC surgery. Systemic disease affecting bone healing. Patients refusing consent. Sex: All
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 |
|---|---|---|
| Custom-made 3D-printed titanium plateCustom-made 3D-printed titanium plates designed through virtual surgical planning based on preoperative CT imaging. The healthy side was mirrored to assist in virtual reconstruction and plate design. The plates were fabricated from biocompatible titanium and sterilized before surgery. | Device | Custom-Made 3D-Printed Titanium Plate |
Primary outcome
Accuracy of Anatomical Reduction
Time frame: Immediate postoperative assessment and 3 months postoperative.
Accuracy of anatomical reduction assessed by comparing postoperative CT findings with the preoperative virtual surgical plan.
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 27 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Zygomaticomaxillary Complex (ZMC) Fractures
Not yet recruiting
Accuracy of Virtual Surgical Planning Versus Traditional Technique in Zygomaticomaxillary Fracture Reduction
Facial Bone Fracture, Maxillofacial Injury
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 Custom-made 3D-printed titanium plate in people with Zygomaticomaxillary Complex (ZMC) Fractures, run by Al-Azhar 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 27 Aug 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?
Accuracy of Anatomical Reduction (time frame: Immediate postoperative assessment and 3 months postoperative.). 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 27 Aug 2026.