Anterior Mandibular FracturePhase 4InterFlexNCT06740292
InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures.
A Phase 4 study testing conventional miniplates and InterFlex plates in people with Anterior Mandibular Fracture, run by Alexandria University at 1 site in Egypt.
Trial summary
the study aims to compare InterFlex plate with conventional miniplates in management of symphyseal mandibular fracture clinically regarding pain, wound healing and postoperative occlusion, and radiographically regrading bone density. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Mandibular Fracture
- What is being tested?
- conventional miniplates and InterFlex plates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2024to 1 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with recent anterior mandibular fracture located between the mental foramina.
- adults without gender predilection who agreed to follow-up,
- fractures requiring open reduction and internal fixation, and
- those medically fit for general anesthesia were included
Who cannot join
- medically compromised patients,
- fractures with infection,
- pathological or old fractures,
- completely edentulous patients,
- comminuted fractures
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, 21523
About this study
Official title: InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures. a Randomized Controlled Clinical Trial
the study aims to compare InterFlex plate with conventional miniplates in management of symphyseal mandibular fracture clinically regarding pain, wound healing and postoperative occlusion, and radiographically regrading bone density.
Read the detailed description
A total of 18 patients with recent symphyseal mandibular fractures were allocated into two groups. Group A, comprising 9 patients, underwent treatment with the InterFlex plate, while Group B, also consisting of 9 patients, was treated with conventional two miniplates. Clinical evaluations were carried at multiple intervals up to 12 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line.
- Conditions
- Anterior Mandibular Fracture
- Being tested
- conventional miniplates, InterFlex plates
- Keywords
- anterior mandibular fracture, symphyseal fracture, para-symphyseal fracture, InterFlex plate, functionally stabilized fixation, miniplate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional miniplatesDevice
conventional miniplates in double configuration
InterFlex platesDevice
InterFlex plates in configuration
| Study group | Role | What they receive |
|---|---|---|
| Patients with anterior mandibular fracture managed with conventional miniplates | Active comparator | Patients with anterior mandibular fracture managed with conventional miniplates Receives: Device: conventional miniplates |
| Patients with anterior mandibular fracture managed with InterFlex plates | Experimental | Patients with anterior mandibular fracture managed with InterFlex plates Receives: Device: InterFlex plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic evaluation for the assessment of mean bone density at the fracture line
Mean bone density at the fracture line was assessed using Cone-Beam Computed Tomography (CBCT) scan in Hounsfield Units (HU)
Measured: 3 months
Secondary outcomes (1)
Clinical evaluation for pain
Pain was assessed using Visual Analogue Scale (VAS)
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start25 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 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
- NCT06740292
- Sponsor's protocol ID
- 0117-12/24
- Acronym
- InterFlex
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures. a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06740292
- Acronym / sponsor ID
- InterFlex / 0117-12/24
- Conditions
- Anterior Mandibular Fracture
- Keywords
- anterior mandibular fracture, symphyseal fracture, para-symphyseal fracture, InterFlex plate, functionally stabilized fixation, miniplate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 18 Dec 2024 (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 study aims to compare InterFlex plate with conventional miniplates in management of symphyseal mandibular fracture clinically regarding pain, wound healing and postoperative occlusion, and radiographically regrading bone density.
Detailed description
A total of 18 patients with recent symphyseal mandibular fractures were allocated into two groups. Group A, comprising 9 patients, underwent treatment with the InterFlex plate, while Group B, also consisting of 9 patients, was treated with conventional two miniplates. Clinical evaluations were carried at multiple intervals up to 12 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with anterior mandibular fracture managed with conventional miniplates | Active comparator | Device: conventional miniplatesPatients with anterior mandibular fracture managed with conventional miniplates |
| Patients with anterior mandibular fracture managed with InterFlex plates | Experimental | Device: InterFlex platesPatients with anterior mandibular fracture managed with InterFlex plates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with recent anterior mandibular fracture located between the mental foramina.
- adults without gender predilection who agreed to follow-up,
- fractures requiring open reduction and internal fixation, and
- those medically fit for general anesthesia were included
Key exclusion criteria (5 listed)
- medically compromised patients,
- fractures with infection,
- pathological or old fractures,
- completely edentulous patients,
- comminuted fractures
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 |
|---|---|---|
| conventional miniplatesconventional miniplates in double configuration | Device | Patients with anterior mandibular fracture managed with conventional miniplates |
| InterFlex platesInterFlex plates in configuration | Device | Patients with anterior mandibular fracture managed with InterFlex plates |
Primary outcome
Radiographic evaluation for the assessment of mean bone density at the fracture line
Time frame: 3 months
Mean bone density at the fracture line was assessed using Cone-Beam Computed Tomography (CBCT) scan in Hounsfield Units (HU)
1 secondary outcome
Clinical evaluation for pain
Time frame: six 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 18 Dec 2024.
- Individual participant dataSharing planned: Yes. all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
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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 conventional miniplates and InterFlex plates in people with Anterior 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 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: finished, as of the sponsor's last update on 18 Dec 2024. 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?
Radiographic evaluation for the assessment of mean bone density at the fracture line (time frame: 3 months). 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 18 Dec 2024.