Mandibular FracturesPhase 4InterlockingNCT06939010
3D Interlocking Miniplates in Fixation of Mandibular Fractures in the Mental Foramen Region: A Split-mouth Study
A Phase 4 study testing 3d-interlocking miniplate and Conventional miniplates in people with Mandibular Fractures and Miniplate, run by Alexandria University at 1 site in Egypt.
Trial summary
the study aims to compare 3D Interlocking miniplates with conventional miniplates in management of mandibular parasymphyseal fractures both clinically and radiographically. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Fractures, Miniplate
- What is being tested?
- 3d-interlocking miniplate and Conventional miniplates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 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 bilateral mandibular fracture located in the mental foramina region.
- 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: 3D Interlocking Miniplates Versus Conventional Miniplates in Fixation of Mandibular Fractures in the Mental Foramen Region: A Split-mouth Study
the study aims to compare 3D Interlocking miniplates with conventional miniplates in management of mandibular parasymphyseal fractures both clinically and radiographically.
Read the detailed description
A total of 12 patients with recent bilateral parasymphyseal mandibular fractures were treated with 3D Interlocking miniplates on one side and with conventional two miniplates in the other side. Clinical evaluations were carried at multiple intervals up to 6 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line
- Conditions
- Mandibular Fractures, Miniplate
- Being tested
- 3d-interlocking miniplate, Conventional miniplates
- Keywords
- Mental nerve, conventional miniplates, 3D Interlocking, mandibular parasymphyseal fracture
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d-interlocking miniplateDevice
3d-interlocking miniplate
Conventional miniplatesDevice
double miniplates in the conventional configuration
| Study group | Role | What they receive |
|---|---|---|
| patient with bilateral fracture in the mental nerve region managed with 3D-interlocking miniplate | Experimental | patient with bilateral fracture in the mental nerve region. one side will be randomly allocated to be managed with 3D-interlocking miniplate Receives: Device: 3d-interlocking miniplate |
| patient with bilateral fracture in the mental nerve region managed with conventional miniplates | Experimental | patient with bilateral fracture in the mental nerve region. one side will be randomly allocated to be managed with conventional miniplates Receives: Device: Conventional miniplates |
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: 12 weeks
Secondary outcomes (1)
Clinical evaluation for Intra-fragmentary mobility
Intra-fragmentary mobility was evaluated by bimanual palpation at the fracture site
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Jan 2023
- Primary completion1 Aug 2024
- Study completion1 Dec 2024
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 FracturesStudies 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
- Model description
- Split-mouth
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 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
- NCT06939010
- Sponsor's protocol ID
- 3D-Interlocking
- Acronym
- Interlocking
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 22 Apr 2025
- 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
Publications
Abdelhamed IM, Sweedan AO, Ismail RM, El-Mahallawy Y. Three-dimensional Interlocking versus conventional miniplates for mandibular fractures fixation near the mental foramen: a split-mouth randomized clinical trial. BMC Oral Health. 2026 Mar 29;26(1):709. doi: 10.1186/s12903-026-07799-5.
PubMed 41906100
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Interlocking Miniplates Versus Conventional Miniplates in Fixation of Mandibular Fractures in the Mental Foramen Region: A Split-mouth Study
- ClinicalTrials.gov ID
- NCT06939010
- Acronym / sponsor ID
- Interlocking / 3D-Interlocking
- Conditions
- Mandibular Fractures, Miniplate
- Keywords
- Mental nerve, conventional miniplates, 3D Interlocking, mandibular parasymphyseal fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 22 Apr 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 study aims to compare 3D Interlocking miniplates with conventional miniplates in management of mandibular parasymphyseal fractures both clinically and radiographically.
Detailed description
A total of 12 patients with recent bilateral parasymphyseal mandibular fractures were treated with 3D Interlocking miniplates on one side and with conventional two miniplates in the other side. Clinical evaluations were carried at multiple intervals up to 6 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
- Model description
- Split-mouth
| Arm | Type | Receives |
|---|---|---|
| patient with bilateral fracture in the mental nerve region managed with 3D-interlocking miniplate | Experimental | Device: 3d-interlocking miniplatepatient with bilateral fracture in the mental nerve region. one side will be randomly allocated to be managed with 3D-interlocking miniplate |
| patient with bilateral fracture in the mental nerve region managed with conventional miniplates | Experimental | Device: Conventional miniplatespatient with bilateral fracture in the mental nerve region. one side will be randomly allocated to be managed with conventional miniplates |
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 bilateral mandibular fracture located in the mental foramina region.
- 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 |
|---|---|---|
| 3d-interlocking miniplate3d-interlocking miniplate | Device | patient with bilateral fracture in the mental nerve region managed with 3D-interlocking miniplate |
| Conventional miniplatesdouble miniplates in the conventional configuration | Device | patient with bilateral fracture in the mental nerve region managed with conventional miniplates |
Primary outcome
Radiographic evaluation for the assessment of mean bone density at the fracture line
Time frame: 12 weeks
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 Intra-fragmentary mobility
Time frame: 6 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 22 Apr 2025.
- Derived from this study: PubMed 41906100Abdelhamed IM, Sweedan AO, Ismail RM, El-Mahallawy Y. Three-dimensional Interlocking versus conventional miniplates for mandibular fractures fixation near the mental foramen: a split-mouth randomized clinical trial. BMC Oral Health. 2026 Mar 29;26(1):709. doi: 10.1186/s12903-026-07799-5.
- 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 3d-interlocking miniplate and Conventional miniplates in people with Mandibular Fractures and Miniplate, 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 22 Apr 2025. 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: 12 weeks). 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 NCT06939010, 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 Apr 2025.