Mandibular Angle FracturePhase 4NCT07375030
Evaluation of Patient-specific Surgical Stents and Plates for Guided Reduction And Fixation of Mandibular Angle Fractures
A Phase 4 study testing Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation and fracture reduction performed using conventional intraoperative manual techniques without a reduction guide. in people with Mandibular Angle Fracture, run by Alexandria University at 1 site in Egypt.
Trial summary
This study will evaluate the patient specific surgical stent and plate for guided reduction and fixation of mandibular angle fractures. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mandibular Angle Fracture
- What is being tested?
- Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation and fracture reduction performed using conventional intraoperative manual techniques without a reduction guide.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Dec 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.
- Patients with mandibular angle fracture indicated for open reduction and internal fixation.
- Presented within 2 weeks from trauma.
Who cannot join
- Infected fracture site.
- Patients with systemic bone diseases.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the patient specific surgical stent and plate for guided reduction and fixation of mandibular angle fractures.
Read the detailed description
14 Patients were allocated into 2 groups: Group A underwent reduction using a patient-specific surgical reduction guide generated through virtual surgical planning, whereas Group B underwent conventional manual reduction Follow-up extended to 12 weeks. Clinical parameters included pain, operative time, postoperative occlusion, wound healing and mouth opening. Radiographic evaluation was conducted using computed tomography scans acquired preoperatively and postoperatively ,superimposition of the pre and postoperative models will be done to create error map and measure the accuracy
- Conditions
- Mandibular Angle Fracture
- Being tested
- Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation, fracture reduction performed using conventional intraoperative manual techniques without a reduction guide.
- Keywords
- Mandibular angle fracture, guided reduction and fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixationDevice
Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation
fracture reduction performed using conventional intraoperative manual techniques without a reduction guide.Device
manual fracture reduction without a guide
| Study group | Role | What they receive |
|---|---|---|
| patients with recent mandibular angle fractures managed with patient specific stents and plates | Experimental | Not described Receives: Device: Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation |
| patients with recent mandibular angle fractures managed with manual techniques. | Active comparator | Not described Receives: Device: fracture reduction performed using conventional intraoperative manual techniques without a reduction guide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of accuracy of surgical reduction and fixation
Evaluation of accuracy of surgical guide will be done using slicer and blender, and mimics 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.
Measured: Day 1
Secondary outcomes (1)
Clinical evaluation for Intra-opreative time
Measured: Intra-opreative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Jan 2024
- Primary completion1 Jun 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Angle 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 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
- NCT07375030
- Sponsor's protocol ID
- 00010824-12/2023
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient-specific Surgical Stents and Plates for Guided Reduction And Fixation of Mandibular Angle Fractures
- ClinicalTrials.gov ID
- NCT07375030
- Acronym / sponsor ID
- 00010824-12/2023
- Conditions
- Mandibular Angle Fracture
- Keywords
- Mandibular angle fracture, guided reduction and fixation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 29 Jan 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 patient specific surgical stent and plate for guided reduction and fixation of mandibular angle fractures.
Detailed description
14 Patients were allocated into 2 groups: Group A underwent reduction using a patient-specific surgical reduction guide generated through virtual surgical planning, whereas Group B underwent conventional manual reduction Follow-up extended to 12 weeks. Clinical parameters included pain, operative time, postoperative occlusion, wound healing and mouth opening. Radiographic evaluation was conducted using computed tomography scans acquired preoperatively and postoperatively ,superimposition of the pre and postoperative models will be done to create error map and measure the accuracy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| patients with recent mandibular angle fractures managed with patient specific stents and plates | Experimental | Device: Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation |
| patients with recent mandibular angle fractures managed with manual techniques. | Active comparator | Device: fracture reduction performed using conventional intraoperative manual techniques without a reduction guide. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Medically fit patients free from relevant conditions contraindicating surgery.
- Patients with mandibular angle fracture indicated for open reduction and internal fixation.
- Presented within 2 weeks from trauma.
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 |
|---|---|---|
| Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixationPatient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation | Device | patients with recent mandibular angle fractures managed with patient specific stents and plates |
| fracture reduction performed using conventional intraoperative manual techniques without a reduction guide.manual fracture reduction without a guide | Device | patients with recent mandibular angle fractures managed with manual techniques. |
Primary outcome
Evaluation of accuracy of surgical reduction and fixation
Time frame: Day 1
Evaluation of accuracy of surgical guide will be done using slicer and blender, and mimics 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.
1 secondary outcome
Clinical evaluation for Intra-opreative time
Time frame: Intra-opreative
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 Aug 2026.
- Individual participant dataSharing planned: Yes
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Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
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Safety-zone Approach and Facial Nerve Preservation in Transbuccal-accessed Fixation of Mandibular Fractures
Facial Nerve Injuries, Mandibular Fractures
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Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures
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Accuracy of Computer Guided Screw Holes Locating Guide and Patient Specific Champy Plate vs Conventional Champy Plate Osteosynthesis in Management of Mandibular Angle Fracture: Randomized Controlled Trial
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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 Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation and fracture reduction performed using conventional intraoperative manual techniques without a reduction guide. in people with Mandibular Angle 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 3 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 18 Aug 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 surgical reduction and fixation (time frame: Day 1). 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 Aug 2026.