Zygomatic FracturesNCT06588075
A Full Digital VS Conventional Protocol in Management of Zygomatico-Maxillary Complex Fracture
A study testing Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow and Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol in people with Zygomatic Fractures, run by Cairo University at 1 site in Egypt.
Trial summary
this study aims To evaluate The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fracture reduction and fixation Using customized Patient-Specific implant and patient-specific predictive holes surgical guide Versus Conventional Technique of reduction and fixation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Zygomatic Fractures
- What is being tested?
- Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow and Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Sep 2024to 1 Jan 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Zygomatic Fracture Types III, IV, V, VII, and VIII according to Rowe and Killey's classification.
- Age range (18-60 years).
- Patients are willing for the surgical procedure and follow-up, with informed consent
Who cannot join
- Zygomatic Fracture Type I, II according to Rowe and Killey's classification.
- Patients with contraindications for general anesthesia.
- Patient on radiotherapy.
- Patients suffer from bone disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Accuracy of Zygomatico-Maxillary Complex Fracture Reduction And Fixation Using A Full Digital Workflow Versus Conventional Protocol: A Randomized Clinical Trial
this study aims To evaluate The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fracture reduction and fixation Using customized Patient-Specific implant and patient-specific predictive holes surgical guide Versus Conventional Technique of reduction and fixation.
Read the detailed description
The ZMC has multiple points of articulation with the craniofacial skeleton making accurate assessment of reduction at all articulations intraoperative in multiple planes very challenging and the interference of soft tissue edema and a narrowed visual field increases the possibility of intraoperative overcorrection or underestimation of pre-injured position of all fracture lines at the same time resulting in a suboptimal reduction. As a trial to maximize the benefits of digital planning carrying the plan into a real operating room using a patient-specific surgical guide to predrill screw holes and guide patient-specific implants during fixation according to the planning depend on CT scan.
- Conditions
- Zygomatic Fractures
- Being tested
- Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow, Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol
- Keywords
- Zygomatic fracture, computer guided surgery, patient specific implant, predictive holes surgical guide, Zygomatico-Maxillary complex fracture
- Medical subject headings
- Zygomatic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flowProcedure or surgery
All surgeries will be carried out under general anesthesia the fracture lines will be exposed then For the study group: following the exposure of all fracture lines , anatomically seated bone-supported predictive holes surgical guides will be inserted on the bone segments with intimate contact. Each segment hole will be drilled according to the predesigned predictive holes guide. The fractured segments will then be reduced and fixed using titanium miniplates customized for the patient and screws at least two screws for each fracture segment. then closure in layers will be performed using absorbable vicryl for deep layers and intraoral sutures and non-absorbable polyproline for skin closure.
Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocolProcedure or surgery
For the control group: all cases will be treated under general anesthesia and the fracture lines will be exposed then the conventional protocol of treatment depend mainly on visualization of the fracture line and tactile sensation of the operator intra-operative during reduction procedure and the fixation of fractured segments will be done using titanium miniplates and screws then closure in layers will be performed.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | all cases that will be allocated in this group will undergo treatment using a full digital protocol depending on planning software and the planning will be carried out into the operating room using 3D printed predictive holes surgical guides to determine accurately the optimum position of customized plates Receives: Procedure: Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow |
| control group | Active comparator | patients in this group will be treated using a conventional protocol of reduction depending on visualization intraoperative and tactile sensation and will be fixed using a stock miniplates and screws. Receives: Procedure: Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zygomatic reposition
the accuracy of zygomatic bone reduction and fixation using postoperative CT scan
Measured: immediate postoperative
Secondary outcomes (3)
intraoperative time
duration of operation using stopwatch
Measured: during the operation
paresthesia
sensation in the area supplied by the infraorbital nerve using a 2 points discrimination test
Measured: pre operative, immediate postoperative and 6 months post operative
patient satisfaction
patient aesthetic satisfaction will be measured using a visual analogue scale from 0 to 10 in a questionnaire form, zero mean not satisfied at all and 10 is the maximum satisfaction.
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Sep 2024
- Primary completion1 Jun 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygomatic FracturesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ayman Fayek, Cairo University
- Investigators
- Dina Ayman Fayek, M.Sc, Principal investigator, Assistant lecturer oral and maxillofacial surgery department Future university in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588075
- Sponsor's protocol ID
- OMFS 3319
- Status last verified
- Feb 2026
- First submitted
- 5 Sep 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the data will be available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Zygomatico-Maxillary Complex Fracture Reduction And Fixation Using A Full Digital Workflow Versus Conventional Protocol: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06588075
- Acronym / sponsor ID
- OMFS 3319
- Conditions
- Zygomatic Fractures
- Keywords
- Zygomatic fracture, computer guided surgery, patient specific implant, predictive holes surgical guide, Zygomatico-Maxillary complex fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 19 Sep 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.
this study aims To evaluate The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fracture reduction and fixation Using customized Patient-Specific implant and patient-specific predictive holes surgical guide Versus Conventional Technique of reduction and fixation.
Detailed description
The ZMC has multiple points of articulation with the craniofacial skeleton making accurate assessment of reduction at all articulations intraoperative in multiple planes very challenging and the interference of soft tissue edema and a narrowed visual field increases the possibility of intraoperative overcorrection or underestimation of pre-injured position of all fracture lines at the same time resulting in a suboptimal reduction. As a trial to maximize the benefits of digital planning carrying the plan into a real operating room using a patient-specific surgical guide to predrill screw holes and guide patient-specific implants during fixation according to the planning depend on CT scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flowall cases that will be allocated in this group will undergo treatment using a full digital protocol depending on planning software and the planning will be carried out into the operating room using 3D printed predictive holes surgical guides to determine accurately the optimum position of customized plates |
| control group | Active comparator | Procedure: Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocolpatients in this group will be treated using a conventional protocol of reduction depending on visualization intraoperative and tactile sensation and will be fixed using a stock miniplates and screws. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Zygomatic Fracture Types III, IV, V, VII, and VIII according to Rowe and Killey's classification.
- Age range (18-60 years).
- Patients are willing for the surgical procedure and follow-up, with informed consent
Key exclusion criteria (4 listed)
- Zygomatic Fracture Type I, II according to Rowe and Killey's classification.
- Patients with contraindications for general anesthesia.
- Patient on radiotherapy.
- Patients suffer from bone disease.
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 |
|---|---|---|
| Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flowAll surgeries will be carried out under general anesthesia the fracture lines will be exposed then For the study group: following the exposure of all fracture lines , anatomically seated bone-supported predictive holes surgical guides will be inserted on the bone segments with intimate contact. Each segment hole will be drilled according to the predesigned predictive holes guide. The fractured segments will then be reduced and fixed using titanium miniplates customized for the patient and screws at least two screws for each fracture segment. then closure in layers will be performed using absorbable vicryl for deep layers and intraoral sutures and non-absorbable polyproline for skin closure. | Procedure or surgery | study group |
| Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocolFor the control group: all cases will be treated under general anesthesia and the fracture lines will be exposed then the conventional protocol of treatment depend mainly on visualization of the fracture line and tactile sensation of the operator intra-operative during reduction procedure and the fixation of fractured segments will be done using titanium miniplates and screws then closure in layers will be performed. | Procedure or surgery | control group |
Primary outcome
Zygomatic reposition
Time frame: immediate postoperative
the accuracy of zygomatic bone reduction and fixation using postoperative CT scan
3 secondary outcomes
intraoperative time
Time frame: during the operation
paresthesia
Time frame: pre operative, immediate postoperative and 6 months post operative
patient satisfaction
Time frame: 6 months 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 18 Feb 2026.
- Individual participant dataSharing planned: Undecided. the data will be available from the corresponding author upon reasonable request.
Related trials for Zygomatic Fractures
Enrolling by invitation
Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fracture
Zygomaticomaxillary Complex Fracture, Zygoma Fracture
Recruiting
BoneTape Feasibility Trial
Zygomaticomaxillary Complex Fracture, Zygomatic Fractures
Enrolling by invitationObservational study
Multi-Institutional IMPACT Validation
Facial Injuries, Mandible Fracture
Not yet recruitingObservational study
Outcomes of Zygomatic Fractures: Cross- Sectional Study
Zygoma Fracture
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.
Dina Ayman Fayek, M.Sc principal investigator
Assistant lecturer oral and maxillofacial surgery department Future university in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow and Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol in people with Zygomatic Fractures, 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 3 inclusion and 4 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 18 Feb 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?
Zygomatic reposition (time frame: immediate 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 18 Feb 2026.