Mandibular FractureNCT07590401
Modified 3d Rectangular Grid Plate for Fixation of Anterior and Body Mandibular Fractures
A study testing Modified 3D Rectangular Grid plate and Two conventional miniplates in people with Mandibular Fracture, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: Fractures of anterior mandible (symphysis and parasymphysis) make up about 9% to 57%, of mandibular fractures, and body fractures make up about 21%; posing challenges for stabilization due to anatomical constraints. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Mandibular Fracture
- What is being tested?
- Modified 3D Rectangular Grid plate and Two conventional miniplates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2025to 7 Apr 2026
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients suffering from recent fractures at the symphysis, parasymphysis and body regions
- Adult patients with no gender predilection who agreed to present for follow-up visits
- A fracture that demands open reduction and internal fixation.
- The patient is medically fit for general anesthesia
Who cannot join
- ASA classification IV, V, VI
- Existence of infection at the fracture line
- Pathological fracture
- An old fracture
- Completely edentulous patient
- Patients with a comminuted fracture
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Evaluation of the Use of Modified 3d Rectangular Grid Plate for Fixation of Anterior and Body Mandibular Fractures (Randomized Controlled Clinical Trial)
Background: Fractures of anterior mandible (symphysis and parasymphysis) make up about 9% to 57%, of mandibular fractures, and body fractures make up about 21%; posing challenges for stabilization due to anatomical constraints. Traditional 3D plates have limitations in this area, leading to the development of Modified 3D Rectangular Grid plates. Studies have shown that these plates offer superior stabilization over larger configurations while maintaining a low profile like miniplates. Additionally, design modifications ensure mental nerve preservation, balancing effective fixation with neurovascular safety.
Aim of this study: To evaluate the use of Modified 3D Rectangular Grid plates in comparison with conventional mini plates for fixation of mandibular fracture in the anterior and body regions, clinically regarding pain, interfragmentary mobility, maximal inter-incisal opening, wound healing, and sensory nerve evaluation, and radiographically regrading fracture reduction.
- Conditions
- Mandibular Fracture
- Being tested
- Modified 3D Rectangular Grid plate, Two conventional miniplates
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified 3D Rectangular Grid plateOther
The system consists of a lower 1.5-mm rectangular plate and an upper linear plate that interlock through circular recesses and elevations. Each component is 0.75 mm thick at the junction, giving a total thickness of 1.5 mm. After screw fixation, it provides 3D stability similar to standard 3D plates while minimizing risk to the mental nerve.
Two conventional miniplatesOther
conventional mini plates for fixation of mandibular fracture in the anterior and body regions
| Study group | Role | What they receive |
|---|---|---|
| 3D plates | Experimental | Not described Receives: Other: Modified 3D Rectangular Grid plate |
| Conventional plates | Active comparator | Not described Receives: Other: Two conventional miniplates |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in maximum mouth opening
Using a millimetre ruler to measure maximal inter-incisal mouth opening; considered to be adequate if >30 mm and inadequate if <30 mm
Measured: up to 12 weeks
change in pain scores
Will be assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe
Measured: up to 12 weeks
change in Neurosensory function
patient was asked about prescence of sensation alteration
Measured: up to 12 weeks
Secondary outcomes (3)
change in Inter-fragmentary Mobility
The mobility will be assessed by bi-manual palpation across the fracture site.
Measured: up to 12 weeks
change in Wound Evaluation
The sutured wounds will be examined for signs and symptoms of infection uisng modified Landry's index
Measured: up to12 weeks
adequacy of fracture line reduction
Whenever alignment of the inferior border of the mandible will be maintained across the fracture line, it will be considered an excellent reduction. If a discrepancy of 1-3 mm will be noted, it will be considered a good reduction. If a discrepancy of 3-5 mm will be noted, it will be labeled as a fair reduction. If the discrepancy will be > 5 mm, it will be considered a poor reduction.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start2 May 2025
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT07590401
- Sponsor's protocol ID
- 1058-04/2025
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 30 Sep 2026
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Modified 3d Rectangular Grid Plate for Fixation of Anterior and Body Mandibular Fractures (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07590401
- Acronym / sponsor ID
- 1058-04/2025
- Conditions
- Mandibular Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 15 May 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.
Background: Fractures of anterior mandible (symphysis and parasymphysis) make up about 9% to 57%, of mandibular fractures, and body fractures make up about 21%; posing challenges for stabilization due to anatomical constraints. Traditional 3D plates have limitations in this area, leading to the development of Modified 3D Rectangular Grid plates. Studies have shown that these plates offer superior stabilization over larger configurations while maintaining a low profile like miniplates. Additionally, design modifications ensure mental nerve preservation, balancing effective fixation with neurovascular safety.
Aim of this study: To evaluate the use of Modified 3D Rectangular Grid plates in comparison with conventional mini plates for fixation of mandibular fracture in the anterior and body regions, clinically regarding pain, interfragmentary mobility, maximal inter-incisal opening, wound healing, and sensory nerve evaluation, and radiographically regrading fracture reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D plates | Experimental | Other: Modified 3D Rectangular Grid plate |
| Conventional plates | Active comparator | Other: Two conventional miniplates |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients suffering from recent fractures at the symphysis, parasymphysis and body regions
- Adult patients with no gender predilection who agreed to present for follow-up visits
- A fracture that demands open reduction and internal fixation.
- The patient is medically fit for general anesthesia
Key exclusion criteria (6 listed)
- ASA classification IV, V, VI
- Existence of infection at the fracture line
- Pathological fracture
- An old fracture
- Completely edentulous patient
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 |
|---|---|---|
| Modified 3D Rectangular Grid plateThe system consists of a lower 1.5-mm rectangular plate and an upper linear plate that interlock through circular recesses and elevations. Each component is 0.75 mm thick at the junction, giving a total thickness of 1.5 mm. After screw fixation, it provides 3D stability similar to standard 3D plates while minimizing risk to the mental nerve. | Other | 3D plates |
| Two conventional miniplatesconventional mini plates for fixation of mandibular fracture in the anterior and body regions | Other | Conventional plates |
Primary outcome
change in maximum mouth opening
Time frame: up to 12 weeks
Using a millimetre ruler to measure maximal inter-incisal mouth opening; considered to be adequate if >30 mm and inadequate if <30 mm
change in pain scores
Time frame: up to 12 weeks
Will be assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe
change in Neurosensory function
Time frame: up to 12 weeks
patient was asked about prescence of sensation alteration
3 secondary outcomes
change in Inter-fragmentary Mobility
Time frame: up to 12 weeks
change in Wound Evaluation
Time frame: up to12 weeks
adequacy of fracture line reduction
Time frame: 12 weeks
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 30 Sep 2026.
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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 study testing Modified 3D Rectangular Grid plate and Two conventional miniplates in people with 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 4 inclusion and 6 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 30 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.
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?
change in maximum mouth opening (time frame: up to 12 weeks). The study lists 3 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 30 Sep 2026.