Condylar Process of Mandible Open FractureNCT07858890
Assessment of Condylar Position With Management of Unilateral Mandibular Angle Fracture
A study testing 2 mini plates and patient specific plates in people with Condylar Process of Mandible Open Fracture, run by Cairo University at 1 site in Egypt.
Trial summary
The objective of this study is to assess condylar position and occlusion after open reduction and internal fixation using two miniplates versus patient specific plate Read more about this study
- Who is it for?
- Ages 17 to 60 years
- Conditions the study is for
- Condylar Process of Mandible Open Fracture
- What is being tested?
- 2 mini plates and patient specific plates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2025to 25 Dec 2025
- 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 17 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Patients with a unilateral angle fracture indicated for Open reduction internal Fixation alone or in combination with fracture elsewhere in the mandible.
- 3. Patients should be free from any systemic disease that may affect normal healing of the bone.
- 4. Patients with good general condition allowing major surgical procedure under general anesthesia.
- 5. Patients with physical and psychological tolerance No history of previous surgical intervention in the angle site
Who cannot join
- Patients with high risk systemic diseases like uncontrolled diabetes mellitus. as uncontrolled diabetes mellitus has a negative impact on normal bone healing
- Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
- Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Condylar Position With Management of Unilateral Mandibular Angle Fracture Using Patient Specific Angle Plate Versus Two Mini Plates (Randomized Clinical Trial)
The objective of this study is to assess condylar position and occlusion after open reduction and internal fixation using two miniplates versus patient specific plate
Read the detailed description
Accordingly, this trial will be held using self-positioning specific plate to overcome such problems of the two-point fixation of mini plates : 1. The virtual planning and with aid of plate wings minimize the need for intra-operative IMF during fixation stage.
2.The virtual planning and fabrication of self-seating wings (lips) of the patient-specific plate ensure the seating of the condyle and centric relation.
Finally, the PSP will make fracture the reduction more accurate and will offer a great advantage of reduction of the operative time .
- Being tested
- 2 mini plates, patient specific plates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 mini platesProcedure or surgery
patients with mandibular angle fractures fixed by 2 mini plates
patient specific platesProcedure or surgery
Angle fracture will be fixed by patient specific plates customized for him
| Study group | Role | What they receive |
|---|---|---|
| patients treated by two mini plates | Active comparator | patient fixed by 2 mini plates Receives: Procedure: 2 mini plates |
| fixation with patient specific plate | Experimental | the Patient specific plate will make fracture the reduction more accurate and will offer a great advantage of reduction of the operative time Receives: Procedure: patient specific plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of condylar position (Linear displacement)
Linear displacement (inter condylar distance) with computed tomography in millimeters
Measured: 3 months
Assessment of condylar position (Angular displacement)
Angular displacement with specialized software in degrees
Measured: 3 months
Secondary outcomes (1)
assessment of occlusion
Assessed by clinical photographs (Binary)
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 posted5 Oct 2026
- Study start25 Aug 2025
- Primary completion25 Nov 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condylar Process of Mandible Open FractureStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yara mamdouh mustafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858890
- Sponsor's protocol ID
- omfs3-3-19
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Condylar Position With Management of Unilateral Mandibular Angle Fracture Using Patient Specific Angle Plate Versus Two Mini Plates (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07858890
- Acronym / sponsor ID
- omfs3-3-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 5 Oct 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.
The objective of this study is to assess condylar position and occlusion after open reduction and internal fixation using two miniplates versus patient specific plate
Detailed description
Accordingly, this trial will be held using self-positioning specific plate to overcome such problems of the two-point fixation of mini plates : 1. The virtual planning and with aid of plate wings minimize the need for intra-operative IMF during fixation stage.
2.The virtual planning and fabrication of self-seating wings (lips) of the patient-specific plate ensure the seating of the condyle and centric relation.
Finally, the PSP will make fracture the reduction more accurate and will offer a great advantage of reduction of the operative time .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients treated by two mini plates | Active comparator | Procedure: 2 mini platespatient fixed by 2 mini plates |
| fixation with patient specific plate | Experimental | Procedure: patient specific platesthe Patient specific plate will make fracture the reduction more accurate and will offer a great advantage of reduction of the operative time |
Who may qualify
- Ages
- 17 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 1. Patients with a unilateral angle fracture indicated for Open reduction internal Fixation alone or in combination with fracture elsewhere in the mandible.
- 3. Patients should be free from any systemic disease that may affect normal healing of the bone.
- 4. Patients with good general condition allowing major surgical procedure under general anesthesia.
- 5. Patients with physical and psychological tolerance No history of previous surgical intervention in the angle site
Key exclusion criteria (3 listed)
- Patients with high risk systemic diseases like uncontrolled diabetes mellitus. as uncontrolled diabetes mellitus has a negative impact on normal bone healing
- Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
- Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity
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 |
|---|---|---|
| 2 mini platespatients with mandibular angle fractures fixed by 2 mini plates | Procedure or surgery | patients treated by two mini plates |
| patient specific platesAngle fracture will be fixed by patient specific plates customized for him | Procedure or surgery | fixation with patient specific plate |
Primary outcome
Assessment of condylar position (Linear displacement)
Time frame: 3 months
Linear displacement (inter condylar distance) with computed tomography in millimeters
Assessment of condylar position (Angular displacement)
Time frame: 3 months
Angular displacement with specialized software in degrees
1 secondary outcome
assessment of 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 5 Oct 2026.
Related trials for Condylar Process of Mandible Open Fracture
Recruiting
Treatment of Intra-articular Fractures of the Mandibular Condyle
Intra-articular Fracture of the Mandibular Condyle
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 study testing 2 mini plates and patient specific plates in people with Condylar Process of Mandible Open Fracture, 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 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: finished, as of the sponsor's last update on 5 Oct 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?
Assessment of condylar position (Linear displacement) (time frame: 3 months). 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 5 Oct 2026.