Mandibular Fracture TreatmentNCT07263893
Inter Flex Three Dimensional Plate in Management of Mandibular Fracture RCT
A study testing Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture in people with Mandibular Fracture Treatment, run by Suez Canal University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if The use of a 3D-designed Inter-flex plate will achieve safe and desirable anatomical \& functional restoration with reduced operative time in mandibular fracture, Improvement of occlusal and inter-cuspal relation in addition to stabilized intra-fragmentary mobility, Offer… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Mandibular Fracture Treatment
- What is being tested?
- Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture
- 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
- 1 Jan 2026to 3 Dec 2026
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable mandibular fractures
- Adult patients with no gender predilection that agreed to present for follow-up visits for minimum postoperative period of immediate,3 months,6 months.
- A fracture that demands open reduction and internal fixation
- Patients under ASA-1 category
Who cannot join
- Comminuted, infected mandibular fracture.
- Pediatric patients below 4 years old and geriatric patients with completely edentulous mouth.
- Patient with osteoporosis
- Medical compromised patient (Poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), Recent (<3 months) MI, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, shock, sepsis, undergoing regularly scheduled dialysis, history (>3 months)
- Fractures in completely edentulous patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mataria Teaching Hospital
Cairo, 2211
abdelkader hegazy, bachelor, 01119980050, abdokita35@gmail.com
About this study
Official title: Evaluation of the Efficacy of Custom-Made Inter-flex Three-Dimensional Plate in Treatment of Mandibular Fracture A Randomized Controlled Clinical Trial
The goal of this clinical trial is to learn if The use of a 3D-designed Inter-flex plate will achieve safe and desirable anatomical \& functional restoration with reduced operative time in mandibular fracture,
- Improvement of occlusal and inter-cuspal relation in addition to stabilized intra-fragmentary mobility,
- Offer greatest resistance to displacement
- shows most favorable biomechanical behavior
Read the detailed description
Mandibular fractures most commonly accompany facial trauma, with nearly half of the patients requiring surgical repair. The treatment of fractures prioritizes the restoration of functionality through The realignment of fractured segments. Conventional methods, such as titanium plates, have been employed for this purpose; however, certain limitations have been observed, such as there is a chance of potential infection and mal-union in mandibular fracture site. Leading to the development of patient specific plates. Furthermore, recent advancements in digital technology in Dentistry enable creation of virtual models and simulations of surgical Procedures. Aim: Is to evaluate the effect of custom-made Inter-flex three dimensional plate vs conventional ready-made Titanium plates in Management of Mandibular Fracture Methodology: This study will be conducted on 20 sites with mandibular fracture in patients. The sites of fracture will be divided into two groups (Group I and Group II) randomly and equally via www.randomizer.org Group I: site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture, Group II: site with mandibular fracture will be treated with a ready-made Titanium plates in site of mandibular fracture. The postoperative clinical evaluation included presence of infection, stability of the mandibular lower border, state of occlusion, maximal mouth opening. Postoperative radiographic examinations to evaluate the accuracy of reduction and bony union using postoperative c.t 24hour and 3 months by measuring the inter-fragmentary gap and the Intergonial distance.
- Conditions
- Mandibular Fracture Treatment
- Being tested
- Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture
- Keywords
- INTER-FLEX 3D PLATE, mandibular fractures, radiographic assesment, time of surgery, healing
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fractureProcedure or surgery
site with mandibular fracture will be reduced and fixation will be done .visibility using custom made Inter-flex three dimensional plate plates in Group I and fixation using custom made Inter-flex three dimensional according to champ's lines of osteo-synthesis in Group I. closure of the surgical field with vicryl suture material (90% glycolide and 10% L-lactide: Ethicon part of Johnson \& Johnson Int, US.).
| Study group | Role | What they receive |
|---|---|---|
| Group I: site with mandibular fracture will be treated with custom made Inter-flex three dimensional | Experimental | site with mandibular fracture will be reduced and fixation will be done .visibility using custom made Inter-flex three dimensional plate plates in Group I and fixation using custom made Inter-flex three dimensional according to champ's lines of osteo-synthesis in Group I. closure of the surgical field with vicryl suture material (90% glycolide and 10% L-lactide: Ethicon part of Johnson \& Johnson Int, US.). Receives: Procedure: Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture |
| Group II: site with mandibular fracture will be treated with a ready-made Titanium plates in site of | No intervention | site with mandibular fracture will be reduced and fixation will be done .visibility using conventional double-mini plates in Group II and fixation using 2 mini-plates according to champ's lines of osteo-synthesis in Group II. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic evaluation
- The linear inter-fragmentary gap between the fractured segments in mm
- Intergonial distance was measured between the most inferior, lateral, and posterior points of the mandible bilaterally as determined on CT in mm.
Measured: 24 hour after surgery and after 3 months
Mobility of fracture segments
assessed through bimanual digital manipulation
- Stable >> no movement of fragments.
- Nonstable >> presence of movement.
Measured: 24 hour after surgery
State of occlusion
will be assessed by asking the patient to bite in maximum intercuspation at each follow-up (intact/deranged) also by recording molar relation as (satisfactory or deranged).
Measured: after 24 hours and after 3 months of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandibular Fracture TreatmentStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Model description
- Brand name thickness Composition Company software Customized CAD CAM milled plates 1mm Titanium plate Arab engineers corporation blender Screws 2mm Titanium screw Arab engineers corporation blender II- Methods: 1. Study Design: Randomized clinical study via www.randomizer.org 2. Study Setting: This study will be conducted on twenty mandibular fracture sites 3. Study population and sampling: Patients will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery department in the Faculty of Dentistry, Suez Canal University also from emergency room of Mataria Teaching Hospital. All patients will be informed with all the details of the surgical procedures, complications and the whole study schedule. Then, each patient will sign an informed consent. Patients participating in the current study will have to fulfill the following eligibility criteria: Inclusion criteria: (Zhao et al., 2018) 1-Patients who are suffering from re
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Ah Elsholukamy, Professor, Study director, Suez Canal UniversityMohamed Na Gad Elhaq, lecturer, Study director, Suez Canal UniversityMaurice Fe khalil, consultant, Study director, Mataria Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263893
- Sponsor's protocol ID
- 2025/1012
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: because these are patient data that cant be shared
Publications
Saad, A., Khalil, A. F., & El-Mahallawy, Y. (2025). INTERFLEX PLATE VERSUS CONVENTIONAL MINIPLATES IN THE MANAGEMENT OF ANTERIOR MANDIBULAR FRACTURES. a RANDOMIZED CONTROLLED CLINICAL TRIAL. Alexandria Dental Journal, 0(0), 0. https://doi.org/10.21608/adjalexu.2025.344361.1572
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Custom-Made Inter-flex Three-Dimensional Plate in Treatment of Mandibular Fracture A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07263893
- Acronym / sponsor ID
- 2025/1012
- Conditions
- Mandibular Fracture Treatment
- Keywords
- INTER-FLEX 3D PLATE, mandibular fractures, radiographic assesment, time of surgery, healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 4 Dec 2025 (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 goal of this clinical trial is to learn if The use of a 3D-designed Inter-flex plate will achieve safe and desirable anatomical \& functional restoration with reduced operative time in mandibular fracture,
- Improvement of occlusal and inter-cuspal relation in addition to stabilized intra-fragmentary mobility,
- Offer greatest resistance to displacement
- shows most favorable biomechanical behavior
Detailed description
Mandibular fractures most commonly accompany facial trauma, with nearly half of the patients requiring surgical repair. The treatment of fractures prioritizes the restoration of functionality through The realignment of fractured segments. Conventional methods, such as titanium plates, have been employed for this purpose; however, certain limitations have been observed, such as there is a chance of potential infection and mal-union in mandibular fracture site. Leading to the development of patient specific plates. Furthermore, recent advancements in digital technology in Dentistry enable creation of virtual models and simulations of surgical Procedures. Aim: Is to evaluate the effect of custom-made Inter-flex three dimensional plate vs conventional ready-made Titanium plates in Management of Mandibular Fracture Methodology: This study will be conducted on 20 sites with mandibular fracture in patients. The sites of fracture will be divided into two groups (Group I and Group II) randomly and equally via www.randomizer.org Group I: site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture, Group II: site with mandibular fracture will be treated with a ready-made Titanium plates in site of mandibular fracture. The postoperative clinical evaluation included presence of infection, stability of the mandibular lower border, state of occlusion, maximal mouth opening. Postoperative radiographic examinations to evaluate the accuracy of reduction and bony union using postoperative c.t 24hour and 3 months by measuring the inter-fragmentary gap and the Intergonial distance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Brand name thickness Composition Company software Customized CAD CAM milled plates 1mm Titanium plate Arab engineers corporation blender Screws 2mm Titanium screw Arab engineers corporation blender II- Methods: 1. Study Design: Randomized clinical study via www.randomizer.org 2. Study Setting: This study will be conducted on twenty mandibular fracture sites 3. Study population and sampling: Patients will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery department in the Faculty of Dentistry, Suez Canal University also from emergency room of Mataria Teaching Hospital. All patients will be informed with all the details of the surgical procedures, complications and the whole study schedule. Then, each patient will sign an informed consent. Patients participating in the current study will have to fulfill the following eligibility criteria: Inclusion criteria: (Zhao et al., 2018) 1-Patients who are suffering from re
| Arm | Type | Receives |
|---|---|---|
| Group I: site with mandibular fracture will be treated with custom made Inter-flex three dimensional | Experimental | Procedure: Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracturesite with mandibular fracture will be reduced and fixation will be done .visibility using custom made Inter-flex three dimensional plate plates in Group I and fixation using custom made Inter-flex three dimensional according to champ's lines of osteo-synthesis in Group I. closure of the surgical field with vicryl suture material (90% glycolide and 10% L-lactide: Ethicon part of Johnson \& Johnson Int, US.). |
| Group II: site with mandibular fracture will be treated with a ready-made Titanium plates in site of | No intervention | –site with mandibular fracture will be reduced and fixation will be done .visibility using conventional double-mini plates in Group II and fixation using 2 mini-plates according to champ's lines of osteo-synthesis in Group II. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable mandibular fractures
- Adult patients with no gender predilection that agreed to present for follow-up visits for minimum postoperative period of immediate,3 months,6 months.
- A fracture that demands open reduction and internal fixation
- Patients under ASA-1 category
Key exclusion criteria (5 listed)
- Comminuted, infected mandibular fracture.
- Pediatric patients below 4 years old and geriatric patients with completely edentulous mouth.
- Patient with osteoporosis
- Medical compromised patient (Poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), Recent (<3 months) MI, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, shock, sepsis, undergoing regularly scheduled dialysis, history (>3 months)
- Fractures in completely edentulous patients
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 |
|---|---|---|
| Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracturesite with mandibular fracture will be reduced and fixation will be done .visibility using custom made Inter-flex three dimensional plate plates in Group I and fixation using custom made Inter-flex three dimensional according to champ's lines of osteo-synthesis in Group I. closure of the surgical field with vicryl suture material (90% glycolide and 10% L-lactide: Ethicon part of Johnson \& Johnson Int, US.). | Procedure or surgery | Group I: site with mandibular fracture will be treated with custom made Inter-flex three dimensional |
Primary outcome
Radiographic evaluation
Time frame: 24 hour after surgery and after 3 months
* The linear inter-fragmentary gap between the fractured segments in mm * Intergonial distance was measured between the most inferior, lateral, and posterior points of the mandible bilaterally as determined on CT in mm.
Mobility of fracture segments
Time frame: 24 hour after surgery
assessed through bimanual digital manipulation * Stable >> no movement of fragments. * Nonstable >> presence of movement.
State of occlusion
Time frame: after 24 hours and after 3 months of surgery
will be assessed by asking the patient to bite in maximum intercuspation at each follow-up (intact/deranged) also by recording molar relation as (satisfactory or deranged).
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 22 Jan 2026.
- Results publicationSaad, A., Khalil, A. F., & El-Mahallawy, Y. (2025). INTERFLEX PLATE VERSUS CONVENTIONAL MINIPLATES IN THE MANAGEMENT OF ANTERIOR MANDIBULAR FRACTURES. a RANDOMIZED CONTROLLED CLINICAL TRIAL. Alexandria Dental Journal, 0(0), 0. https://doi.org/10.21608/adjalexu.2025.344361.1572
- INTERFLEX PLATE VERSUS CONVENTIONAL MINIPLATES IN THE MANAGEMENT OF ANTERIOR MANDIBULAR FRACTURES. A RANDOMIZED CONTROLLED CLINICAL TRIALLink provided by the sponsor.
- Individual participant dataSharing planned: No. because these are patient data that cant be shared
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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.
Mohamed Ah Elsholukamy, Professor study director
Suez Canal University
Mohamed Na Gad Elhaq, lecturer study director
Suez Canal University
Maurice Fe khalil, consultant study director
Mataria Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture in people with Mandibular Fracture Treatment, run by Suez Canal 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 5 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: looking for participants now, as of the sponsor's last update on 22 Jan 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?
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?
Contact abdelkader hegazy, bachelor (+201119980050, abdokita35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic evaluation (time frame: 24 hour after surgery and after 3 months). 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?
On the ClinicalTrials.gov record for NCT07263893, which also lists 1 linked publication.
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 22 Jan 2026.