Mandibular Angle FracturePhase 4NCT07390734
Patient Specific 3d Titanium Plate Versus Standard Two Mini Plates in the Fixation of Mandibular Angle Fractures (a Randomized Controlled Clinical Trial)
A Phase 4 study testing custom-made 3D titanium plates and standared two mini plates in people with Mandibular Angle Fracture, run by Alexandria University at 1 site in Egypt.
Trial summary
To compare the effectiveness of custom-made (3D) titanium plates to standard two titanium mini plates in fixation of mandibular angle fracture. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Mandibular Angle Fracture
- What is being tested?
- custom-made 3D titanium plates and standared two mini plates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 30 Apr 2026
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients suffering from mandibular angle fracture indicated for open reduction and fixation.
- Non infected mandibular angle fractures present less than two weeks. 3. Good oral hygiene.
Who cannot join
- Medically compromised patients contradicting operation (ASA III, IV \& V).
- Patients receiving radiotherapy or chemotherapy. 3- Bone diseases (Osteoporosis, Osteopetrosis, Osteomalacia…etc.) 4- Pathological fracture. 5- Old untreated fracture.
Trial locations and contacts
1 site in 1 country.
About this study
To compare the effectiveness of custom-made (3D) titanium plates to standard two titanium mini plates in fixation of mandibular angle fracture.
Read the detailed description
16 patients with mandibular angle fractures will be selected. In 8 fractures, custom-made three dimensional titanium plates will be used for fracture fixation (study group); while in the other 8, conventional two mini plates will be used (control group),via intra oral approach (combined with transbuccal approach) for both groups. Patients will be evaluated clinically, and radiographically (immediate and four months post operative) to evaluate the bone density at the fracture line.
- Conditions
- Mandibular Angle Fracture
- Being tested
- custom-made 3D titanium plates, standared two mini plates
- Keywords
- three dimensional plates, mandibular angle fracture, patient specific plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custom-made 3D titanium platesDevice
custom-made 3D titanium plates through intaoral and transbuccal approach .
standared two mini platesDevice
internal fixation with standared two mini plates through intaoral and transbuccal approach.
| Study group | Role | What they receive |
|---|---|---|
| patients with recent mandibular angle fractures managed with custom-made 3D titanium plates | Experimental | patients that will undergo internal fixation with custom-made 3D titanium plates through intaoral and transbuccal approach . Receives: Device: custom-made 3D titanium plates |
| patients with recent mandibular angle fractures managed with standared two mini plates | Experimental | patient that will undergo internal fixation with standared two mini plates through intaoral and transbuccal approach. Receives: Device: standared two mini plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal mouth opening
measurement of inter incisal distance between maxillary and mandibular central incisors.
Measured: This will be assessed at 1, 7, 14, 30 days postoperatively.
Secondary outcomes (6)
Post operative pain
- Post operative pain This will be subjectively evaluated with a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain).
Measured: 3 months
Radiographic evaluation for the assessment of mean bone density at the fracture line
Mean bone density at the fracture line was assessed using Computed Tomography (CT) scan in Hounsfield Units (HU)
Measured: Immediately postopreative and at 4 months
Postoperative occlusion
By checking the maximal inter-cuspal position (centric occlusion) to ensure proper occlusal relationship including molar relation, canine relation and midline centralization. Any occlusal disturbance including open bite or improper tooth contact will be noted.
Measured: This will be assessed at 1, 7, 14, 30 days postoperatively.
Edema
determined using a measuring tape. Three measurements were made between 5 reference points: tragus, soft tissue pogonion, lateral corner of the eye, angle of the mandible, and outer corner of the mouth, preoperatively, and on the 1 ,7 ,14,30 postoperative days.
Measured: This will be assessed at 1, 7, 14, 30 days postoperatively.
Wound healing
The sutured wounds will be examined for signs and symptoms of infection including swelling, redness, hotness, pus discharge, and pain in addition to observation for any manifestations of wound healing disturbance, as wound dehiscence and hardware exposure, and the wound will be assessed according to Landry et al. index
Measured: the wound will be assessed aat 1, 7 and 14,30 days postoperatively.
Operative time
Time form start of fracture reduction to fixation measured in minutes
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 posted5 Feb 2026
- Study start1 Jan 2025
- Primary completion30 Dec 2025
- Study completion30 Apr 2026
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.
- 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
- Outcomes assessor
- Enrolment
- 16 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
- NCT07390734
- Sponsor's protocol ID
- 1023-01/2025
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 28 Sep 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Specific 3d Titanium Plate Versus Standard Two Mini Plates in the Fixation of Mandibular Angle Fractures (a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07390734
- Acronym / sponsor ID
- 1023-01/2025
- Conditions
- Mandibular Angle Fracture
- Keywords
- three dimensional plates, mandibular angle fracture, patient specific plate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 5 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.
To compare the effectiveness of custom-made (3D) titanium plates to standard two titanium mini plates in fixation of mandibular angle fracture.
Detailed description
16 patients with mandibular angle fractures will be selected. In 8 fractures, custom-made three dimensional titanium plates will be used for fracture fixation (study group); while in the other 8, conventional two mini plates will be used (control group),via intra oral approach (combined with transbuccal approach) for both groups. Patients will be evaluated clinically, and radiographically (immediate and four months post operative) to evaluate the bone density at the fracture line.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| patients with recent mandibular angle fractures managed with custom-made 3D titanium plates | Experimental | Device: custom-made 3D titanium platespatients that will undergo internal fixation with custom-made 3D titanium plates through intaoral and transbuccal approach . |
| patients with recent mandibular angle fractures managed with standared two mini plates | Experimental | Device: standared two mini platespatient that will undergo internal fixation with standared two mini plates through intaoral and transbuccal approach. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients suffering from mandibular angle fracture indicated for open reduction and fixation.
- Non infected mandibular angle fractures present less than two weeks. 3. Good oral hygiene.
Key exclusion criteria (2 listed)
- Medically compromised patients contradicting operation (ASA III, IV \& V).
- Patients receiving radiotherapy or chemotherapy. 3- Bone diseases (Osteoporosis, Osteopetrosis, Osteomalacia…etc.) 4- Pathological fracture. 5- Old untreated fracture.
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 |
|---|---|---|
| custom-made 3D titanium platescustom-made 3D titanium plates through intaoral and transbuccal approach . | Device | patients with recent mandibular angle fractures managed with custom-made 3D titanium plates |
| standared two mini platesinternal fixation with standared two mini plates through intaoral and transbuccal approach. | Device | patients with recent mandibular angle fractures managed with standared two mini plates |
Primary outcome
Maximal mouth opening
Time frame: This will be assessed at 1, 7, 14, 30 days postoperatively.
measurement of inter incisal distance between maxillary and mandibular central incisors.
6 secondary outcomes
Post operative pain
Time frame: 3 months
Radiographic evaluation for the assessment of mean bone density at the fracture line
Time frame: Immediately postopreative and at 4 months
Postoperative occlusion
Time frame: This will be assessed at 1, 7, 14, 30 days postoperatively.
Edema
Time frame: This will be assessed at 1, 7, 14, 30 days postoperatively.
Wound healing
Time frame: the wound will be assessed aat 1, 7 and 14,30 days postoperatively.
Operative 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 28 Sep 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 custom-made 3D titanium plates and standared two mini plates 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 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 28 Sep 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?
Maximal mouth opening (time frame: This will be assessed at 1, 7, 14, 30 days 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 28 Sep 2026.