Mandibular Fracture Treatmentz-FIXNCT07184762
Evaluation of Z-shaped Bone Plates in Management of Mandibular Fractures
A study testing open reduction and internal fixation with bone plate, z-plates. and conventional miniplates. in people with Mandibular Fracture Treatment, run by Suez Canal University at 1 site in Egypt.
Trial summary
he goal of this clinical trial is to evaluate Z shaped bone plate in mandibular fracture treatment regarding post operative healing, function restoration and esthetic. aims to answer are: In mandibular trauma population, what is the difference between internal fixation using conventional miniplates compared to z… Read more about this study
- Who is it for?
- Ages 19 to 50 years
- Conditions the study is for
- Mandibular Fracture Treatment
- What is being tested?
- open reduction and internal fixation with bone plate, z-plates. and conventional miniplates.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jan 2024to Nov 2025
- 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 19 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable fractures at the symphysial or parasymphysis region of the mandible.
- Adult patients with no gender predilection that agreed to present for follow-up visits for minimum postoperative period of immediate, month, 3 months,6 months.
- A fracture that demands open reduction and internal fixation
- Medically fit patients for general anesthesia
Who cannot join
- Comminuted, infected mandibular fracture.
- Pediatric patients below 14 years of age
- geriatric patients with completely edentulous mouth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical, Radiographic and Histological Evaluation of Z-shaped Bone Plates in Management of Mandibular Fractures
he goal of this clinical trial is to evaluate Z shaped bone plate in mandibular fracture treatment regarding post operative healing, function restoration and esthetic.
aims to answer are: In mandibular trauma population, what is the difference between internal fixation using conventional miniplates compared to z shaped bone plates regarding post operative healing, function restoration and esthetic?
Participants will be divided equally and randomly in 2 groups as follows:
Group A: eight patients treated with Z shaped bone plate. (Study group) Group B: eight patients restored with conventional two miniplates.(control group)
Read the detailed description
Introduction: Various miniplate systems have been developed in recent years including three-dimensional miniplate, microplates and bioresorbable plate, and their advantages and disadvantages have been compared and studied. To overcome the shortcomings of 3D plating system such as difficulty in adaptation and fixation in fractures involving the mental nerve, a Z plate has been designed. Aim: to evaluate Z shaped bone plates in mandibular fracture management clinically, radiographically, and histologically. Methodology: sixteen patients with mandibular fracture grouped to two groups group A managed by Z plates, group B managed by two miniplates. Patients will follow up clinically postoperative. Radiographic evaluation will be performed immediately postoperative, 1 month and 4 months Experimental study will be on dogs and histological evaluation.
- Conditions
- Mandibular Fracture Treatment
- Being tested
- open reduction and internal fixation with bone plate, z-plates., conventional miniplates.
- Keywords
- mandibular fracture, open reduction, z-shaped plate, conventional bone plates
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open reduction and internal fixation with bone plateProcedure or surgery
mandibular fracture were reduced and fixed with bone plates.
z-plates.Procedure or surgery
mandibular fracture were reduced and fixed with z-plate miniplates.
conventional miniplates.Procedure or surgery
mandibular fracture were reduced and fixed with conventional two miniplates.
| Study group | Role | What they receive |
|---|---|---|
| z-plate | Experimental | mandibular fracture will be reduced and fixed with Z shaped bone plate Receives: Procedure: open reduction and internal fixation with bone plate; Procedure: z-plates. |
| conventional Miniplate | Active comparator | mandibular fracture will be reduced and fixed with conventional two miniplates. Receives: Procedure: open reduction and internal fixation with bone plate; Procedure: conventional miniplates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic evaluation (Bone density ratio at fracture line ) measured using orthopantomograms (OPGs) by ImageJ software.
Radiographic evaluation using orthopantomograms (OPGs) is performed immediately postoperatively, at 1 month and 4 months.
To assess bone density along the fracture line, a densitometric analysis was conducted using the ImageJ system.
Digital images are analyzed using ImageJ software. The mean gray value of a region of interest (ROI) drawn along the entire length of the fracture line was calculated. This gray value represents the relative bone density within the fracture site. Range: 0.0 - 1.0 (unitless ratio).
Higher values indicate greater bone density and better healing
Measured: within 1week postoperative, 1month, 4month
Postoperative pain assessed using the Visual Analog Scale (VAS)
postoperative pain assessed using the Visual Analog Scale (VAS). Range: 0 (no pain) - 10 (worst imaginable pain). Higher scores indicate worse pain
Measured: day 1 , day 3, and 1week postoperative
Secondary outcomes (1)
Clinical fracture stability evaluated by manual mobility test and tenderness on palpation.
Outcome: Stable vs. unstable fracture (binary measure) assessed through bimanual digital manipulation i. Stable >> no movement of fragments. ii. Nonstable>> presence of movement
Measured: 1 week postoperative,1month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start28 Jan 2024
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Fracture TreatmentStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed Eldemardash Ali, Suez Canal University
- Investigators
- Mohamed S. Hamed, professor, Study chair, Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal UniversityMohamed A. Elsholkamy, professor, Study director, Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal UniversityAmr A. Gomaa, associate professor, Study director, plastic Surgery, Faculty of medicine, Suez Canal UniversityEman M. Eldemardash, assistant lecturer, Principal investigator, Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184762
- Sponsor's protocol ID
- 657\2023
- Acronym
- z-FIX
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Histological Evaluation of Z-shaped Bone Plates in Management of Mandibular Fractures
- ClinicalTrials.gov ID
- NCT07184762
- Acronym / sponsor ID
- z-FIX / 657\2023
- Conditions
- Mandibular Fracture Treatment
- Keywords
- mandibular fracture, open reduction, z-shaped plate, conventional bone plates
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 28 Jan 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 22 Sep 2025 (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.
he goal of this clinical trial is to evaluate Z shaped bone plate in mandibular fracture treatment regarding post operative healing, function restoration and esthetic.
aims to answer are: In mandibular trauma population, what is the difference between internal fixation using conventional miniplates compared to z shaped bone plates regarding post operative healing, function restoration and esthetic?
Participants will be divided equally and randomly in 2 groups as follows:
Group A: eight patients treated with Z shaped bone plate. (Study group) Group B: eight patients restored with conventional two miniplates.(control group)
Detailed description
Introduction: Various miniplate systems have been developed in recent years including three-dimensional miniplate, microplates and bioresorbable plate, and their advantages and disadvantages have been compared and studied. To overcome the shortcomings of 3D plating system such as difficulty in adaptation and fixation in fractures involving the mental nerve, a Z plate has been designed. Aim: to evaluate Z shaped bone plates in mandibular fracture management clinically, radiographically, and histologically. Methodology: sixteen patients with mandibular fracture grouped to two groups group A managed by Z plates, group B managed by two miniplates. Patients will follow up clinically postoperative. Radiographic evaluation will be performed immediately postoperative, 1 month and 4 months Experimental study will be on dogs and histological evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| z-plate | Experimental | Procedure: open reduction and internal fixation with bone plate, Procedure: z-plates.mandibular fracture will be reduced and fixed with Z shaped bone plate |
| conventional Miniplate | Active comparator | Procedure: open reduction and internal fixation with bone plate, Procedure: conventional miniplates.mandibular fracture will be reduced and fixed with conventional two miniplates. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable fractures at the symphysial or parasymphysis region of the mandible.
- Adult patients with no gender predilection that agreed to present for follow-up visits for minimum postoperative period of immediate, month, 3 months,6 months.
- A fracture that demands open reduction and internal fixation
- Medically fit patients for general anesthesia
Key exclusion criteria (3 listed)
- Comminuted, infected mandibular fracture.
- Pediatric patients below 14 years of age
- geriatric patients with completely edentulous mouth.
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 |
|---|---|---|
| open reduction and internal fixation with bone platemandibular fracture were reduced and fixed with bone plates. | Procedure or surgery | conventional Miniplate, z-plate |
| z-plates.mandibular fracture were reduced and fixed with z-plate miniplates. | Procedure or surgery | z-plate |
| conventional miniplates.mandibular fracture were reduced and fixed with conventional two miniplates. | Procedure or surgery | conventional Miniplate |
Primary outcome
Radiographic evaluation (Bone density ratio at fracture line ) measured using orthopantomograms (OPGs) by ImageJ software.
Time frame: within 1week postoperative, 1month, 4month
Radiographic evaluation using orthopantomograms (OPGs) is performed immediately postoperatively, at 1 month and 4 months. To assess bone density along the fracture line, a densitometric analysis was conducted using the ImageJ system. Digital images are analyzed using ImageJ software. The mean gray value of a region of interest (ROI) drawn along the entire length of the fracture line was calculated. This gray value represents the relative bone density within the fracture site. Range: 0.0 - 1.0 (unitless ratio). Higher values indicate greater bone density and better healing
Postoperative pain assessed using the Visual Analog Scale (VAS)
Time frame: day 1 , day 3, and 1week postoperative
postoperative pain assessed using the Visual Analog Scale (VAS). Range: 0 (no pain) - 10 (worst imaginable pain). Higher scores indicate worse pain
1 secondary outcome
Clinical fracture stability evaluated by manual mobility test and tenderness on palpation.
Time frame: 1 week postoperative,1month, 3 months, 6 months
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 22 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Mohamed S. Hamed, professor study chair
Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University
Mohamed A. Elsholkamy, professor study director
Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University
Amr A. Gomaa, associate professor study director
plastic Surgery, Faculty of medicine, Suez Canal 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 open reduction and internal fixation with bone plate, z-plates. and conventional miniplates. in people with Mandibular Fracture Treatment, run by Suez Canal 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 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. 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?
Radiographic evaluation (Bone density ratio at fracture line ) measured using orthopantomograms (OPGs) by ImageJ software. (time frame: within 1week postoperative, 1month, 4month). The study lists 2 primary outcomes in all. 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 22 Sep 2025.