Mandibular Angle FracturesNCT07902063
Clinical And Radiographic Assessment of H-shaped Bone Plates in Management of Body and Angle Mandibular Fractures
A study testing open reduction and fixation of the fracture and open reduction and fixation of body and angle mandible fracture in people with Mandibular Angle Fractures and Mandibular Body Fractures, run by Suez Canal University.
Trial summary
Clinical and Radiographic Assessment of H-shaped Bone Plates in Management of Body and Angle Mandibular Fractures Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Mandibular Angle Fractures, Mandibular Body Fractures
- What is being tested?
- open reduction and fixation of the fracture and open reduction and fixation of body and angle mandible fracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients presenting with recent, uninfected, and minimally displaced or unfavorable fractures at the body region of the mandible or the mandibular angle.
- Adult patients aged between 21 and 60 years old who agree to comply with the 6-month postoperative follow-up schedule (immediate, 1 month, 3 months, and 6 months).
- Patients with a mandibular fracture requiring open reduction and internal fixation (ORIF).
- Patients who are medically fit to undergo general anesthesia.
Who cannot join
- Patients presenting with comminuted or clinically infected mandibular fractures.
- Patients under 21 years of age, or patients over 60 years of age with a completely edentulous mouth.
- Patients with systemic medical conditions or compromises that interfere with normal bone healing or contraindicate general anesthesia.
About this study
Clinical and Radiographic Assessment of H-shaped Bone Plates in Management of Body and Angle Mandibular Fractures
Read the detailed description
Various miniplate systems have been developed in recent years including three-dimensional miniplate, microplates and bioresorbable plates, their advantages and disadvantages have been extensively compared and studied. To overcome the shortcomings of 3D plating system such as difficulty in adaptation and fixation in fractures involving the mental nerve, a novel Hplate has been designed. Aim: to evaluate H-shaped bone plates in mandibular fracture management clinically and radiographically.
- Being tested
- open reduction and fixation of the fracture, open reduction and fixation of body and angle mandible fracture
- Keywords
- Mandibular body fracture, Mandibular angle fracture, H shape plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open reduction and fixation of the fractureProcedure or surgery
the use of H shape plate in fixation of body and angle mandibular fracture
open reduction and fixation of body and angle mandible fractureProcedure or surgery
the use of conventional plate in fixation of body and angle mandibular fracture
| Study group | Role | What they receive |
|---|---|---|
| Patients that will receive H shape plates | Experimental | Patients with body or angle mandibular fracture will receive H shape plate for fixation Receives: Procedure: open reduction and fixation of the fracture |
| Control group conventional plates | Active comparator | paitents with body or angle mandiblar fracture will recive conventional plates for fixation Receives: Procedure: open reduction and fixation of body and angle mandible fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity as Assessed by a Visual Analogue Scale (VAS) at 1 and 7 Days Postoperatively
The Visual Analogue Scale (VAS) consists of a 10-centimeter (cm) line, with two endpoints representing a minimum value of 0 ("no pain") and a maximum value of 10 ("pain as bad as it could possibly be"). Patients rate their current level of pain by placing a mark on the line. Higher scores indicate a worse outcome (increased pain intensity).
Measured: one to seven days after operation
Postoperative Facial Edema as Measured by the Tape Measuring Test at 1 and 7 Days Postoperatively
Facial swelling is quantified using a flexible tape measure while the patient is seated upright with teeth in occlusion. Measurements are recorded in centimeters (cm) as the sum of two lines connecting four predetermined facial reference points: ear tragus to the corner of the mouth, and gonion to the external canthus of the eye. Changes occurring between the follow-up intervals and baseline will be reported. An increase in the sum of these measurements indicates a worse outcome (increased swelling).
Measured: one to seven days after operation
Proportion of Participants with Stable Fracture Segments as Assessed by Bimanual Digital Manipulation at 1 and 7 Days Postoperatively
Bimanual digital manipulation is performed clinically by the investigator to evaluate the mobility of the bone fracture segments. Fracture segment stability is recorded as a categorical outcome: 1) "Stable" (indicating no movement of fragments, representing a successful/better outcome) or 2) "Nonstable" (indicating the presence of movement, representing a worse outcome).
Measured: one to seven days
Change from Baseline in Radiographic Bone Density at the Fracture Line at 1 and 4 Months Postoperatively
Panoramic radiographs are performed using a digital panoramic machine to evaluate progressive bone healing. Bone density is quantified by measuring the radiographic gray-scale values at the site of the plate over the fracture line using OnDemand software. An increase in gray-scale value over time relative to the immediate postoperative baseline indicates progressive bone healing and successful bone union, representing a better outcome.
Measured: Immediate postoperatively (baseline), 1 month, and 4 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Angle FracturesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902063
- Sponsor's protocol ID
- 2026/1140
- Status last verified
- Jul 2026
- First submitted
- 30 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical And Radiographic Assessment of H-shaped Bone Plates in Management of Body and Angle Mandibular Fractures
- ClinicalTrials.gov ID
- NCT07902063
- Acronym / sponsor ID
- 2026/1140
- Keywords
- Mandibular body fracture, Mandibular angle fracture, H shape plate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 28 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.
Clinical and Radiographic Assessment of H-shaped Bone Plates in Management of Body and Angle Mandibular Fractures
Detailed description
Various miniplate systems have been developed in recent years including three-dimensional miniplate, microplates and bioresorbable plates, their advantages and disadvantages have been extensively compared and studied. To overcome the shortcomings of 3D plating system such as difficulty in adaptation and fixation in fractures involving the mental nerve, a novel Hplate has been designed. Aim: to evaluate H-shaped bone plates in mandibular fracture management clinically and radiographically.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients that will receive H shape plates | Experimental | Procedure: open reduction and fixation of the fracturePatients with body or angle mandibular fracture will receive H shape plate for fixation |
| Control group conventional plates | Active comparator | Procedure: open reduction and fixation of body and angle mandible fracturepaitents with body or angle mandiblar fracture will recive conventional plates for fixation |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients presenting with recent, uninfected, and minimally displaced or unfavorable fractures at the body region of the mandible or the mandibular angle.
- Adult patients aged between 21 and 60 years old who agree to comply with the 6-month postoperative follow-up schedule (immediate, 1 month, 3 months, and 6 months).
- Patients with a mandibular fracture requiring open reduction and internal fixation (ORIF).
- Patients who are medically fit to undergo general anesthesia.
Key exclusion criteria (3 listed)
- Patients presenting with comminuted or clinically infected mandibular fractures.
- Patients under 21 years of age, or patients over 60 years of age with a completely edentulous mouth.
- Patients with systemic medical conditions or compromises that interfere with normal bone healing or contraindicate general anesthesia.
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 |
|---|---|---|
| open reduction and fixation of the fracturethe use of H shape plate in fixation of body and angle mandibular fracture | Procedure or surgery | Patients that will receive H shape plates |
| open reduction and fixation of body and angle mandible fracturethe use of conventional plate in fixation of body and angle mandibular fracture | Procedure or surgery | Control group conventional plates |
Primary outcome
Postoperative Pain Intensity as Assessed by a Visual Analogue Scale (VAS) at 1 and 7 Days Postoperatively
Time frame: one to seven days after operation
The Visual Analogue Scale (VAS) consists of a 10-centimeter (cm) line, with two endpoints representing a minimum value of 0 ("no pain") and a maximum value of 10 ("pain as bad as it could possibly be"). Patients rate their current level of pain by placing a mark on the line. Higher scores indicate a worse outcome (increased pain intensity).
Postoperative Facial Edema as Measured by the Tape Measuring Test at 1 and 7 Days Postoperatively
Time frame: one to seven days after operation
Facial swelling is quantified using a flexible tape measure while the patient is seated upright with teeth in occlusion. Measurements are recorded in centimeters (cm) as the sum of two lines connecting four predetermined facial reference points: ear tragus to the corner of the mouth, and gonion to the external canthus of the eye. Changes occurring between the follow-up intervals and baseline will be reported. An increase in the sum of these measurements indicates a worse outcome (increased swelling).
Proportion of Participants with Stable Fracture Segments as Assessed by Bimanual Digital Manipulation at 1 and 7 Days Postoperatively
Time frame: one to seven days
Bimanual digital manipulation is performed clinically by the investigator to evaluate the mobility of the bone fracture segments. Fracture segment stability is recorded as a categorical outcome: 1) "Stable" (indicating no movement of fragments, representing a successful/better outcome) or 2) "Nonstable" (indicating the presence of movement, representing a worse outcome).
Change from Baseline in Radiographic Bone Density at the Fracture Line at 1 and 4 Months Postoperatively
Time frame: Immediate postoperatively (baseline), 1 month, and 4 months postoperative
Panoramic radiographs are performed using a digital panoramic machine to evaluate progressive bone healing. Bone density is quantified by measuring the radiographic gray-scale values at the site of the plate over the fracture line using OnDemand software. An increase in gray-scale value over time relative to the immediate postoperative baseline indicates progressive bone healing and successful bone union, representing a better outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing open reduction and fixation of the fracture and open reduction and fixation of body and angle mandible fracture in people with Mandibular Angle Fractures and Mandibular Body Fractures, run by Suez Canal University.
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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative Pain Intensity as Assessed by a Visual Analogue Scale (VAS) at 1 and 7 Days Postoperatively (time frame: one to seven days after operation). The study lists 4 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 28 Oct 2026.