Zygomaticomaxillary Complex FractureNCT07608380
Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fracture
A study testing Patient-specific positioning guide and Customized titanium plate in people with Zygomaticomaxillary Complex Fracture and Zygoma Fracture, run by Cairo University at 1 site in Egypt.
Trial summary
This prospective, single-arm case series aims to evaluate the accuracy of a virtual planning-based positioning guide and customized titanium plate for the reduction and fixation of unilateral zygomaticomaxillary complex (ZMC) fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Zygomaticomaxillary Complex Fracture, Zygoma Fracture, Zygomatic Fractures
- What is being tested?
- Patient-specific positioning guide and Customized titanium plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Dec 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients diagnosed with Zygomatico-maxillary complex fractures requiring surgical intervention.
- Patients aged 18 years or older.
- Patients willing to provide informed consent and comply with follow-up protocols.
- Patients with adequate bone quality and quantity for stable fixation.
Who cannot join
- Patients with comminuted ZMC fractures that preclude the use of custom-made guides based on mirroring the contra lateral side.
- Patients with pre-existing facial deformities or asymmetries that would interfere with accurate assessment of fracture reduction.
- Patients with systemic diseases or conditions that contraindicate elective surgery or impair bone healing (e.g., uncontrolled diabetes, severe osteoporosis, active malignancy, and immunosuppression).
- Patients on medications affecting bone metabolism (e.g., long-term corticosteroids, bisphosphonates). Patients with active infections in the maxillofacial region.
- Pregnant or lactating women.
- Patients with psychiatric disorders or unrealistic expectations.
- Patients who are unable to undergo CT scans or follow post-operative instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
department of oral and maxillofacial surgery, faculty of dentistry, Cairo university
Cairo
About this study
Official title: Accuracy of Positioning Guide and Customized Titanium Plate for Reduction and Fixation of Zygomaticomaxillary Complex Fracture: A Case Series
This prospective, single-arm case series aims to evaluate the accuracy of a virtual planning-based positioning guide and customized titanium plate for the reduction and fixation of unilateral zygomaticomaxillary complex (ZMC) fractures.
The primary objective is to assess fracture reduction accuracy by comparing postoperative CT findings with the preoperative virtual surgical plan. Secondary objectives are to evaluate fixation stability and patient satisfaction.
Participants undergo preoperative CT imaging for virtual surgical planning, followed by surgical reduction and fixation using a patient-specific positioning guide and customized titanium plate. Postoperative CT imaging is used to assess reduction accuracy, with subsequent follow-up to evaluate fixation stability and patient satisfaction.
Read the detailed description
The study evaluates the accuracy of a patient-specific positioning guide and customized titanium plate for the reduction and fixation of unilateral zygomaticomaxillary complex (ZMC) fractures.
All patients undergo a thorough medical and dental history and comprehensive clinical examination. Clinical measurements and photographic documentation are obtained to assess facial symmetry, ocular function, and mouth opening. A preoperative computed tomography (CT) scan (T0) is obtained within one week before surgery to assess the fracture pattern and the extent of displacement. The Digital Imaging and Communications in Medicine (DICOM) data are imported into specialized medical imaging software (e.g., Mimics, 3-matic, or equivalent) for three-dimensional reconstruction and virtual surgical planning (VSP).
During the virtual planning phase, the fractured zygomaticomaxillary complex is first virtually reduced by mirroring the unaffected contralateral side to establish the planned anatomical position. If mirroring is not feasible, established anatomical landmarks and anatomical norms are used to guide the virtual reduction. The customized titanium plate is then designed on the virtually reduced model to fit the planned bone contours. The screw positions and trajectories are also planned, and the screws are virtually positioned within their corresponding fracture segments to define the intended fixation configuration.
After finalizing the plate and screw design in the reduced position, the zygomatic complex is virtually returned to its original displaced fracture position while maintaining the planned screw positions relative to their respective bone segments. The patient-specific positioning guide is then designed on this unreduced model. The guide incorporates the planned drilling locations, allowing the screw holes to be predrilled in the original fracture position. These predrilled holes subsequently guide the reduction and allow the customized plate to be positioned and fixed according to the original virtual surgical plan.
The customized titanium plate is designed using computer-aided design (CAD) and manufactured using computer-aided manufacturing (CAM). The design is exported in STL format, and machining programs are generated for production. The plate is fabricated from medical-grade Titanium Grade 4 using a three-axis CNC milling machine (MILLSTAR, Taiwan), through a subtractive manufacturing process. The machined plate undergoes deburring, polishing, anodizing, cleaning, and packing before use. Digital planning and fabrication are performed by Arab Engineers for Designs and Medical Instrumentation in collaboration with the research team.
Surgical treatment is performed under general anesthesia using lateral eyebrow and intraoral vestibular incisions to expose the fracture site. The patient-specific positioning guide is placed on the zygomatic complex in its original displaced fracture position. The planned screw holes are predrilled through the guide. After removal of the guide, the fracture segments are reduced using the predrilled holes as references to reproduce the planned anatomical position. The customized titanium plate is then positioned according to the planned screw positions and secured with screws to achieve fixation. The surgical site is irrigated and the incisions are closed in layers.
A postoperative CT scan (T1) is obtained within one week after surgery to assess the accuracy of fracture reduction and plate placement. The preoperative virtual surgical plan and postoperative CT model are imported into imaging software and superimposed. Linear and angular deviations between the planned and achieved positions of anatomical landmarks and plate positions are measured in millimeters and degrees. Measurements are performed by the researcher and verified by the main supervisor.
Clinical follow-up is conducted at 1 week, 1 month, 3 months, 6 months to assess wound healing, facial symmetry, ocular function, mouth opening, and postoperative complications, including infection, nerve paresthesia, malunion, and non-union. A follow-up CT scan (T2) is planned at 6 months to evaluate bone healing and fixation stability, including any signs of loosening or displacement. Patient satisfaction is assessed using a Visual Analog Scale (VAS) ranging from 0 to 10.
- Being tested
- Patient-specific positioning guide, Customized titanium plate
- Keywords
- Zygomaticomaxillary Complex Fracture, Zygoma Fracture, custom made titanium plate, virtual surgical planning, positioning guide
- Medical subject headings
- Zygomatic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-specific positioning guideDevice
Also called positioning guide
A 3D-printed positioning guide designed through virtual surgical planning to assist in the accurate reduction of ZMC fractures.
Customized titanium plateDevice
Also called customised plate
A custom-fabricated titanium plate designed to fit the patient's specific anatomy for rigid fixation of ZMC fractures.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Planning and Customized Plates | Experimental | Patients with ZMC fractures undergoing surgical treatment using 3D virtual planning and patient-specific titanium plates. Receives: Device: Patient-specific positioning guide; Device: Customized titanium plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Fracture Reduction
Evaluation of the accuracy of fracture reduction achieved using the positioning guide and customized titanium plate. This will be assessed by superimposing the post-operative computed tomography (CT) scans onto the pre-operative virtual surgical plan. The difference will be reported as linear deviation, measured in millimeters (mm).
Measured: one week postoperative
Secondary outcomes (2)
Fixation stability
Measured in millimeters by comparing the 6-month follow-up CT to the immediate postoperative CT to check for hardware or bone displacement.
Measured: 6 months postoperatively
Patient satisfaction
Evaluation of the patient's overall satisfaction with the functional and aesthetic outcomes of the procedure. This will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates "completely dissatisfied" and 10 indicates "completely satisfied". The reported value will be the numerical score on this scale
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start18 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygomaticomaxillary Complex FractureStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdellatif Saad Abdellatif Nawar, Cairo University
- Investigators
- Prof. Ramy Ragab Elbialy, prof. of maxillofacial surgery, Study director, Department of Oral and maxillofacial surgery,Faculty of dentistry, Cairo universityDr. Mohamed Ali Zain Elabden, lecturer of maxillofacial surg, Study director, Department of Oral and maxillofacial surgery, Faculty of dentistry, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608380
- Sponsor's protocol ID
- OMFS3319
- Status last verified
- Nov 2026
- First submitted
- 29 Apr 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Positioning Guide and Customized Titanium Plate for Reduction and Fixation of Zygomaticomaxillary Complex Fracture: A Case Series
- ClinicalTrials.gov ID
- NCT07608380
- Acronym / sponsor ID
- OMFS3319
- Keywords
- Zygomaticomaxillary Complex Fracture, Zygoma Fracture, custom made titanium plate, virtual surgical planning, positioning guide
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 May 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 case series aims to evaluate the accuracy of a virtual planning-based positioning guide and customized titanium plate for the reduction and fixation of unilateral zygomaticomaxillary complex (ZMC) fractures.
The primary objective is to assess fracture reduction accuracy by comparing postoperative CT findings with the preoperative virtual surgical plan. Secondary objectives are to evaluate fixation stability and patient satisfaction.
Participants undergo preoperative CT imaging for virtual surgical planning, followed by surgical reduction and fixation using a patient-specific positioning guide and customized titanium plate. Postoperative CT imaging is used to assess reduction accuracy, with subsequent follow-up to evaluate fixation stability and patient satisfaction.
Detailed description
The study evaluates the accuracy of a patient-specific positioning guide and customized titanium plate for the reduction and fixation of unilateral zygomaticomaxillary complex (ZMC) fractures.
All patients undergo a thorough medical and dental history and comprehensive clinical examination. Clinical measurements and photographic documentation are obtained to assess facial symmetry, ocular function, and mouth opening. A preoperative computed tomography (CT) scan (T0) is obtained within one week before surgery to assess the fracture pattern and the extent of displacement. The Digital Imaging and Communications in Medicine (DICOM) data are imported into specialized medical imaging software (e.g., Mimics, 3-matic, or equivalent) for three-dimensional reconstruction and virtual surgical planning (VSP).
During the virtual planning phase, the fractured zygomaticomaxillary complex is first virtually reduced by mirroring the unaffected contralateral side to establish the planned anatomical position. If mirroring is not feasible, established anatomical landmarks and anatomical norms are used to guide the virtual reduction. The customized titanium plate is then designed on the virtually reduced model to fit the planned bone contours. The screw positions and trajectories are also planned, and the screws are virtually positioned within their corresponding fracture segments to define the intended fixation configuration.
After finalizing the plate and screw design in the reduced position, the zygomatic complex is virtually returned to its original displaced fracture position while maintaining the planned screw positions relative to their respective bone segments. The patient-specific positioning guide is then designed on this unreduced model. The guide incorporates the planned drilling locations, allowing the screw holes to be predrilled in the original fracture position. These predrilled holes subsequently guide the reduction and allow the customized plate to be positioned and fixed according to the original virtual surgical plan.
The customized titanium plate is designed using computer-aided design (CAD) and manufactured using computer-aided manufacturing (CAM). The design is exported in STL format, and machining programs are generated for production. The plate is fabricated from medical-grade Titanium Grade 4 using a three-axis CNC milling machine (MILLSTAR, Taiwan), through a subtractive manufacturing process. The machined plate undergoes deburring, polishing, anodizing, cleaning, and packing before use. Digital planning and fabrication are performed by Arab Engineers for Designs and Medical Instrumentation in collaboration with the research team.
Surgical treatment is performed under general anesthesia using lateral eyebrow and intraoral vestibular incisions to expose the fracture site. The patient-specific positioning guide is placed on the zygomatic complex in its original displaced fracture position. The planned screw holes are predrilled through the guide. After removal of the guide, the fracture segments are reduced using the predrilled holes as references to reproduce the planned anatomical position. The customized titanium plate is then positioned according to the planned screw positions and secured with screws to achieve fixation. The surgical site is irrigated and the incisions are closed in layers.
A postoperative CT scan (T1) is obtained within one week after surgery to assess the accuracy of fracture reduction and plate placement. The preoperative virtual surgical plan and postoperative CT model are imported into imaging software and superimposed. Linear and angular deviations between the planned and achieved positions of anatomical landmarks and plate positions are measured in millimeters and degrees. Measurements are performed by the researcher and verified by the main supervisor.
Clinical follow-up is conducted at 1 week, 1 month, 3 months, 6 months to assess wound healing, facial symmetry, ocular function, mouth opening, and postoperative complications, including infection, nerve paresthesia, malunion, and non-union. A follow-up CT scan (T2) is planned at 6 months to evaluate bone healing and fixation stability, including any signs of loosening or displacement. Patient satisfaction is assessed using a Visual Analog Scale (VAS) ranging from 0 to 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Planning and Customized Plates | Experimental | Device: Patient-specific positioning guide, Device: Customized titanium platePatients with ZMC fractures undergoing surgical treatment using 3D virtual planning and patient-specific titanium plates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with Zygomatico-maxillary complex fractures requiring surgical intervention.
- Patients aged 18 years or older.
- Patients willing to provide informed consent and comply with follow-up protocols.
- Patients with adequate bone quality and quantity for stable fixation.
Key exclusion criteria (7 listed)
- Patients with comminuted ZMC fractures that preclude the use of custom-made guides based on mirroring the contra lateral side.
- Patients with pre-existing facial deformities or asymmetries that would interfere with accurate assessment of fracture reduction.
- Patients with systemic diseases or conditions that contraindicate elective surgery or impair bone healing (e.g., uncontrolled diabetes, severe osteoporosis, active malignancy, and immunosuppression).
- Patients on medications affecting bone metabolism (e.g., long-term corticosteroids, bisphosphonates). Patients with active infections in the maxillofacial region.
- Pregnant or lactating women.
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 |
|---|---|---|
| Patient-specific positioning guideAlso: positioning guideA 3D-printed positioning guide designed through virtual surgical planning to assist in the accurate reduction of ZMC fractures. | Device | Virtual Planning and Customized Plates |
| Customized titanium plateAlso: customised plateA custom-fabricated titanium plate designed to fit the patient's specific anatomy for rigid fixation of ZMC fractures. | Device | Virtual Planning and Customized Plates |
Primary outcome
Accuracy of Fracture Reduction
Time frame: one week postoperative
Evaluation of the accuracy of fracture reduction achieved using the positioning guide and customized titanium plate. This will be assessed by superimposing the post-operative computed tomography (CT) scans onto the pre-operative virtual surgical plan. The difference will be reported as linear deviation, measured in millimeters (mm).
2 secondary outcomes
Fixation stability
Time frame: 6 months postoperatively
Patient satisfaction
Time frame: 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 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.
Prof. Ramy Ragab Elbialy, prof. of maxillofacial surgery study director
Department of Oral and maxillofacial surgery,Faculty of dentistry, Cairo university
Dr. Mohamed Ali Zain Elabden, lecturer of maxillofacial surg study director
Department of Oral and maxillofacial surgery, Faculty of dentistry, Cairo 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 Patient-specific positioning guide and Customized titanium plate in people with Zygomaticomaxillary Complex Fracture and Zygoma Fracture, run by Cairo 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 7 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: enrolling by invitation, as of the sponsor's last update on 4 Nov 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?
This study is still under way. Results are not available in the source record yet.
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 Fracture Reduction (time frame: one week 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 4 Nov 2026.