Mandibular FracturePhase 4NCT07385924
Evaluation of the Accuracy of 3d Printed Reduction Guide in Treatment of Mandibular Fractures Using Two Different Methods of Virtual Planning
A Phase 4 study testing Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique. and Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique. in people with Mandibular Fracture and Virtual Plan of Mandibular Fracture, run by Alexandria University at 1 site in Egypt.
Trial summary
This study will evaluate the accuracy of the use of 3-D printed reduction guide in treatment of mandibular fractures using two different methods of virtual planning. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mandibular Fracture, Virtual Plan of Mandibular Fracture
- What is being tested?
- Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique. and Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Nov 2025
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Medically fit patients free from relevant conditions contraindicating surgery.
- Unilateral mandibular fractures indicated for open reduction and internal fixation
Who cannot join
- Infected fracture site.
- Patients with systemic bone diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Accuracy of the Use of 3d Printed Reduction Guide in Treatment of Mandibular Fractures Using Two Different Methods of Virtual Planning
This study will evaluate the accuracy of the use of 3-D printed reduction guide in treatment of mandibular fractures using two different methods of virtual planning.
Read the detailed description
This study will be conducted clinically on 24 patients with mandibular fracture divided into 2 groups, (group A) virtual planning will be done using the manual virtual reduction method and (group B) virtual planning will be done using the mirror image technique. Design of the reduction guide will be done in accordance with the virtual plan. The surgical reduction will be done with the aid of the guide.
- Being tested
- Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique., Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique.
- Keywords
- mandibular fracture, virtual surgical planning
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique.Device
Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique.
Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique.Device
Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique.
| Study group | Role | What they receive |
|---|---|---|
| virtual planning will be done using the manual virtual reduction method | Experimental | virtual planning will be done using the manual virtual reduction method and . Design of the reduction guide will be done in accordance with the virtual plan. The surgical reduction will be done with the aid of the guide. Receives: Device: Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique. |
| virtual planning will be done using the mirror image technique. | Experimental | virtual planning will be done using the mirror image technique. Design of the reduction guide will be done in accordance with the virtual plan. The surgical reduction will be done with the aid of the guide. Receives: Device: Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of accuracy of mandibular reduction of each surgical guide.
Evaluation of accuracy of surgical guide will be done using slicer and blender software with the aid of the preoperative and postoperative CT.
Preoperative planning will be merged with the new CT data to identify the accuracy of reduction.
Landmark-Based Positional Analysis was used to quantify positional accuracy of the reduced mandibular segment. Bilateral mandibular landmarks were selected to represent the spatial position of the fractured and adjacent segments. The selected landmarks included condylion (Co), gonion (Go), and mental foramen (MF), which are distributed across the mandibular ramus, angle, and body regions. linear distances to the three reference planes were recorded in millimeters. To provide a comprehensive three-dimensional representation of positional discrepancy, an asymmetry index (AI) was calculated for each bilateral landmark.
Measured: Immediately after the surgery
Secondary outcomes (1)
Clinical evaluation of postoperative occlusion
Assessment of occlusion will be done By checking the maximal intercuspal position (centric occlusion) to ensure proper occlusal relationship including molar relation, canine relation and midline centralization.
The percentage of patients suffering from occlusal disturbances will be recorded.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Feb 2024
- Primary completion1 Jul 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular FractureStudies of the same condition, open and under way.
- More trials run by Alexandria 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385924
- Sponsor's protocol ID
- 00010825-12/2023
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy of the Use of 3d Printed Reduction Guide in Treatment of Mandibular Fractures Using Two Different Methods of Virtual Planning
- ClinicalTrials.gov ID
- NCT07385924
- Acronym / sponsor ID
- 00010825-12/2023
- Keywords
- mandibular fracture, virtual surgical planning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 4 Feb 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 study will evaluate the accuracy of the use of 3-D printed reduction guide in treatment of mandibular fractures using two different methods of virtual planning.
Detailed description
This study will be conducted clinically on 24 patients with mandibular fracture divided into 2 groups, (group A) virtual planning will be done using the manual virtual reduction method and (group B) virtual planning will be done using the mirror image technique. Design of the reduction guide will be done in accordance with the virtual plan. The surgical reduction will be done with the aid of the guide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| virtual planning will be done using the manual virtual reduction method | Experimental | Device: Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique.virtual planning will be done using the manual virtual reduction method and . Design of the reduction guide will be done in accordance with the virtual plan. The surgical reduction will be done with the aid of the guide. |
| virtual planning will be done using the mirror image technique. | Experimental | Device: Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique.virtual planning will be done using the mirror image technique. Design of the reduction guide will be done in accordance with the virtual plan. The surgical reduction will be done with the aid of the guide. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Medically fit patients free from relevant conditions contraindicating surgery.
- Unilateral mandibular fractures indicated for open reduction and internal fixation
Key exclusion criteria (2 listed)
- Infected fracture site.
- Patients with systemic bone diseases.
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 |
|---|---|---|
| Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique.Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique. | Device | virtual planning will be done using the manual virtual reduction method |
| Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique.Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique. | Device | virtual planning will be done using the mirror image technique. |
Primary outcome
Evaluation of accuracy of mandibular reduction of each surgical guide.
Time frame: Immediately after the surgery
Evaluation of accuracy of surgical guide will be done using slicer and blender software with the aid of the preoperative and postoperative CT. Preoperative planning will be merged with the new CT data to identify the accuracy of reduction. Landmark-Based Positional Analysis was used to quantify positional accuracy of the reduced mandibular segment. Bilateral mandibular landmarks were selected to represent the spatial position of the fractured and adjacent segments. The selected landmarks included condylion (Co), gonion (Go), and mental foramen (MF), which are distributed across the mandibular ramus, angle, and body regions. linear distances to the three reference planes were recorded in millimeters. To provide a comprehensive three-dimensional representation of positional discrepancy, an asymmetry index (AI) was calculated for each bilateral landmark.
1 secondary outcome
Clinical evaluation of postoperative occlusion
Time frame: 3 months
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 4 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
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 Phase 4 study testing Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique. and Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique. in people with Mandibular Fracture and Virtual Plan of Mandibular Fracture, run by Alexandria 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 2 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 4 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluation of accuracy of mandibular reduction of each surgical guide. (time frame: Immediately after the surgery). 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 Feb 2026.