Mandibular Class Iv FracturesNCT07153354
Patient-Specific Guides vs. Classical Workflow in Class IV Mandibular Fracture Fixation
A study testing patient-specific screw holes locating surgical guide and pre-bent plates and 2 titanium per-bent mini plates in people with Mandibular Class Iv Fractures, run by Mohamed abdelsalam Gaber elkhouly.
Trial summary
This study aims to overcome the limitations of current, standard approach of mandibular fracture reduction and fixation including improper alignment of segments, malocclusion, nerve affections and related teeth roots injury. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandibular Class Iv Fractures
- What is being tested?
- patient-specific screw holes locating surgical guide and pre-bent plates and 2 titanium per-bent mini plates
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with delayed mandibular class IV fracture need open reduction and internal fixation.
- Patients with a medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene.
- Both genders, males and females, will be included
Who cannot join
- General contraindications to surgery.
- Patients with unfavorable or comminuted fractures.
- Subjected to irradiation in the head and neck area less than 1 year before fixation.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
- Pregnant or nursing.
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- Substance abuse.
- Psychiatric problems or unrealistic expectations.
- Severe bruxism or clenching.
- Immunosuppressed or immunocompromised.
- Treated or under treatment with intravenous amino-bisphosphonates.
- Patients participating in other studies, if the present protocol could not be properly followed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Precision of Patient-specific Screw Holes Locating Surgical Guide and Pre-bent Plates Osteosynthesis Versus Classical Workflow in the Management of Class IV Mandibular Fractures
This study aims to overcome the limitations of current, standard approach of mandibular fracture reduction and fixation including improper alignment of segments, malocclusion, nerve affections and related teeth roots injury. The introduction of Computer Aided designing/Computer Aided manufacturing software has provided surgeons with an opportunity to perform virtual manipulations of computed tomography datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication.
- Conditions
- Mandibular Class Iv Fractures
- Being tested
- patient-specific screw holes locating surgical guide and pre-bent plates, 2 titanium per-bent mini plates
- Keywords
- Per-bent plates, Class iv mandibular fractures, Surgical guide, patient-specific screw holes locating surgical guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient-specific screw holes locating surgical guide and pre-bent platesDevice
Virtual reduction of the fracture will be done, followed by 3D printing of the corrected mandible model. Plates will be pre-bent on the model, then scanned in position to create a surgical guide for accurate screw hole placement during surgery.
2 titanium per-bent mini platesDevice
The fixation will be performed according to established surgical principles for managing class iv mandibular fractures, without patient-specific planning
| Study group | Role | What they receive |
|---|---|---|
| patient-specific screw holes locating surgical guide and pre-bent plates osteosynthesis | Experimental | Patients In this group will be reduced using patient computer-guided specific screw holes locating guide and pre-bent plates(2.3 for inferior border and 2.0 for superior border) Receives: Device: patient-specific screw holes locating surgical guide and pre-bent plates |
| classical work-flow | Active comparator | Patients In this group will be reduced by classical reduction and fixation protocol Receives: Device: 2 titanium per-bent mini plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of fracture reduction
Accuracy of fracture reduction, measured as the mean linear deviation (in millimeters) between the postoperative Computed Tomography scan and the preoperative virtual surgical plan
Method of assessment: Postoperative Computed Tomography scans will be superimposed onto the preoperative virtual plan using 3D analysis software (e.g., Mimics/3-matic or equivalent). Linear and angular deviations of fracture segments will be calculated at predefined anatomical landmarks.
Measured: Within one week postoperatively
Secondary outcomes (2)
Occlusion
change in occlusion will be assessed by a maxillofacial surgeon at each follow-up visit (1 week, 1 month, 3 months, 6 months postoperatively) using Angle's classification and clinical examination.
Unit of Measure: Presence/absence of malocclusion (Yes/No)
Measured: At 1 week, 1 month, 3 months, and 6 months postoperatively
Operation time
Total duration from skin incision to wound closure, recorded intraoperatively.
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Class Iv FracturesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed abdelsalam Gaber elkhouly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed abdelsalam Gaber elkhouly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153354
- Sponsor's protocol ID
- 3D-T4F-RCT-2025
- Status last verified
- Aug 2025
- First submitted
- 26 May 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision of Patient-specific Screw Holes Locating Surgical Guide and Pre-bent Plates Osteosynthesis Versus Classical Workflow in the Management of Class IV Mandibular Fractures
- ClinicalTrials.gov ID
- NCT07153354
- Acronym / sponsor ID
- 3D-T4F-RCT-2025
- Conditions
- Mandibular Class Iv Fractures
- Keywords
- Per-bent plates, Class iv mandibular fractures, Surgical guide, patient-specific screw holes locating surgical guide
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mohamed abdelsalam Gaber elkhoulyUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 3 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.
This study aims to overcome the limitations of current, standard approach of mandibular fracture reduction and fixation including improper alignment of segments, malocclusion, nerve affections and related teeth roots injury. The introduction of Computer Aided designing/Computer Aided manufacturing software has provided surgeons with an opportunity to perform virtual manipulations of computed tomography datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient-specific screw holes locating surgical guide and pre-bent plates osteosynthesis | Experimental | Device: patient-specific screw holes locating surgical guide and pre-bent platesPatients In this group will be reduced using patient computer-guided specific screw holes locating guide and pre-bent plates(2.3 for inferior border and 2.0 for superior border) |
| classical work-flow | Active comparator | Device: 2 titanium per-bent mini platesPatients In this group will be reduced by classical reduction and fixation protocol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with delayed mandibular class IV fracture need open reduction and internal fixation.
- Patients with a medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene.
- Both genders, males and females, will be included
Key exclusion criteria (12 listed)
- General contraindications to surgery.
- Patients with unfavorable or comminuted fractures.
- Subjected to irradiation in the head and neck area less than 1 year before fixation.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
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 screw holes locating surgical guide and pre-bent platesVirtual reduction of the fracture will be done, followed by 3D printing of the corrected mandible model. Plates will be pre-bent on the model, then scanned in position to create a surgical guide for accurate screw hole placement during surgery. | Device | patient-specific screw holes locating surgical guide and pre-bent plates osteosynthesis |
| 2 titanium per-bent mini platesThe fixation will be performed according to established surgical principles for managing class iv mandibular fractures, without patient-specific planning | Device | classical work-flow |
Primary outcome
Accuracy of fracture reduction
Time frame: Within one week postoperatively
Accuracy of fracture reduction, measured as the mean linear deviation (in millimeters) between the postoperative Computed Tomography scan and the preoperative virtual surgical plan Method of assessment: Postoperative Computed Tomography scans will be superimposed onto the preoperative virtual plan using 3D analysis software (e.g., Mimics/3-matic or equivalent). Linear and angular deviations of fracture segments will be calculated at predefined anatomical landmarks.
2 secondary outcomes
Occlusion
Time frame: At 1 week, 1 month, 3 months, and 6 months postoperatively
Operation time
Time frame: During the surgery
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 3 Sep 2025.
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.
Questions about this trial
What is this clinical trial studying?
A study testing patient-specific screw holes locating surgical guide and pre-bent plates and 2 titanium per-bent mini plates in people with Mandibular Class Iv Fractures, run by Mohamed abdelsalam Gaber elkhouly.
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 12 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: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mohamed Abelsalam Gaber Elkhouly (01009837389, mohamed.gaber@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of fracture reduction (time frame: Within one week postoperatively). 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 3 Sep 2025.