Mandibular Fracture TraumaNCT07058597
Fixation of Fractures at Anterior Transition Zone Using Three Different Miniplates Configurations
A study testing Twinfork plate, 3D-interlocking plate and Miniplate in people with Mandibular Fracture Trauma and Mandible Fracture, run by Alexandria University at 1 site in Egypt.
Trial summary
Fractures involving the anterior transition zone of the mandible are frequently encountered and hold particular clinical significance due to the presence of the mental nerve. Consequently, mental nerve paresthesia is among the common postoperative complications associated with these fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Fracture Trauma, Mandible Fracture
- What is being tested?
- Twinfork plate, 3D-interlocking plate and Miniplate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 1 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from recent, uninfected and minimally displaced or unfavorable fractures at parasymphysis-body region of the mandible
- Adult patients from 20-40 years old with no gender predilection that agreed to present for follow-up visits for a minimum postoperative period of 3 months.
- A fracture that demands open reduction and internal fixation.
- The patient medically fit for general anesthesia.
Who cannot join
- Medically compromised patients contradicting operation.
- Pathological fracture.
- An old fracture.
- Completely edentulous patient.
- Patients with frank infection.
- Patients with a comminuted fracture.
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: Assessment of Mental Nerve Integrity During Fixation of Fractures at Anterior Transition Zone Using Three Different Miniplates Configurations
Fractures involving the anterior transition zone of the mandible are frequently encountered and hold particular clinical significance due to the presence of the mental nerve. Consequently, mental nerve paresthesia is among the common postoperative complications associated with these fractures. To assess the mental nerve functional integrity during fixation of fractures at the anterior transition zone using twin fork-miniplate, 3d interlocking miniplate and two miniplates
Read the detailed description
A total of 36 patients (they were divided into three groups 16 patients in each group ) with parasymphyseal-body fractures , one group was treated with twin-fork miniplate , the second group was treated using 3d interlocking miniplate and the third one was treated with conventional two miniplates. Postoperative evaluation of the mental nerve was conducted using both subjective and objective methods at intervals of 24 hours, and at 1, 4, 6 and 12 weeks. Furthermore, an electrophysiological study was performed at 6 weeks postoperatively to measure the mental nerve's amplitude, onset latency and conduction velocity
- Conditions
- Mandibular Fracture Trauma, Mandible Fracture
- Being tested
- Twinfork plate, 3D-interlocking plate, Miniplate
- Keywords
- mandibular fractures, anterior transition zone, mental nerve, electrophysiological study
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twinfork plateDevice
Twinfork plate
3D-interlocking plateDevice
3D-interlocking plate
MiniplateDevice
Miniplate
| Study group | Role | What they receive |
|---|---|---|
| Patients with mandibular fracture in the anterior transition zone managed with Twinfork plate | Active comparator | Patients with mandibular fracture in the anterior transition zone managed with Twinfork plate Receives: Device: Twinfork plate |
| Patients with mandibular fracture in the anterior transition zone managed with 3D-interlocking | Active comparator | Patients with mandibular fracture in the anterior transition zone managed with 3D-interlocking plate Receives: Device: 3D-interlocking plate |
| Patients with mandibular fracture in the anterior transition zone managed with miniplates | Experimental | Patients with mandibular fracture in the anterior transition zone managed with miniplates Receives: Device: Miniplate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory nerve function
Objective assessment by using a dental probe pressure to determine any sensory changes along the distribution of the mental nerve in comparison to the contralateral side (nociceptive method).
Measured: 6 weeks
Secondary outcomes (1)
Radiographic evaluation for fracture healing
Preoperative CT scan will be obtained, immediate CT scan will be used to assess the adequacy of fracture line reduction and fixation, and then another CT will be taken at 12th week to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Aug 2020
- Primary completion1 Oct 2024
- Study completion1 Feb 2025
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 TraumaStudies 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
- Model description
- Patients with with fractures in the anterior transition zone managed with 3 different configurations of miniplates
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 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
- NCT07058597
- Sponsor's protocol ID
- AMTZ-3G-2025
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 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
Ismail RM, Abdelhamed IM, Samir W, Alryess AM, El-Mahallawy Y. Impact of three miniplate configurations on mental nerve integrity in parasymphyseal mandibular fractures: a blinded randomized trial. BMC Oral Health. 2026 May 7;26(1):859. doi: 10.1186/s12903-026-08487-0.
PubMed 42098721
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mental Nerve Integrity During Fixation of Fractures at Anterior Transition Zone Using Three Different Miniplates Configurations
- ClinicalTrials.gov ID
- NCT07058597
- Acronym / sponsor ID
- AMTZ-3G-2025
- Conditions
- Mandibular Fracture Trauma, Mandible Fracture
- Keywords
- mandibular fractures, anterior transition zone, mental nerve, electrophysiological study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 10 Jul 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.
Fractures involving the anterior transition zone of the mandible are frequently encountered and hold particular clinical significance due to the presence of the mental nerve. Consequently, mental nerve paresthesia is among the common postoperative complications associated with these fractures. To assess the mental nerve functional integrity during fixation of fractures at the anterior transition zone using twin fork-miniplate, 3d interlocking miniplate and two miniplates
Detailed description
A total of 36 patients (they were divided into three groups 16 patients in each group ) with parasymphyseal-body fractures , one group was treated with twin-fork miniplate , the second group was treated using 3d interlocking miniplate and the third one was treated with conventional two miniplates. Postoperative evaluation of the mental nerve was conducted using both subjective and objective methods at intervals of 24 hours, and at 1, 4, 6 and 12 weeks. Furthermore, an electrophysiological study was performed at 6 weeks postoperatively to measure the mental nerve's amplitude, onset latency and conduction velocity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Patients with with fractures in the anterior transition zone managed with 3 different configurations of miniplates
| Arm | Type | Receives |
|---|---|---|
| Patients with mandibular fracture in the anterior transition zone managed with Twinfork plate | Active comparator | Device: Twinfork platePatients with mandibular fracture in the anterior transition zone managed with Twinfork plate |
| Patients with mandibular fracture in the anterior transition zone managed with 3D-interlocking | Active comparator | Device: 3D-interlocking platePatients with mandibular fracture in the anterior transition zone managed with 3D-interlocking plate |
| Patients with mandibular fracture in the anterior transition zone managed with miniplates | Experimental | Device: MiniplatePatients with mandibular fracture in the anterior transition zone managed with 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 suffering from recent, uninfected and minimally displaced or unfavorable fractures at parasymphysis-body region of the mandible
- Adult patients from 20-40 years old with no gender predilection that agreed to present for follow-up visits for a minimum postoperative period of 3 months.
- A fracture that demands open reduction and internal fixation.
- The patient medically fit for general anesthesia.
Key exclusion criteria (6 listed)
- Medically compromised patients contradicting operation.
- Pathological fracture.
- An old fracture.
- Completely edentulous patient.
- Patients with frank infection.
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 |
|---|---|---|
| Twinfork plateTwinfork plate | Device | Patients with mandibular fracture in the anterior transition zone managed with Twinfork plate |
| 3D-interlocking plate3D-interlocking plate | Device | Patients with mandibular fracture in the anterior transition zone managed with 3D-interlocking |
| MiniplateMiniplate | Device | Patients with mandibular fracture in the anterior transition zone managed with miniplates |
Primary outcome
Sensory nerve function
Time frame: 6 weeks
Objective assessment by using a dental probe pressure to determine any sensory changes along the distribution of the mental nerve in comparison to the contralateral side (nociceptive method).
1 secondary outcome
Radiographic evaluation for fracture healing
Time frame: 3 months
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 10 Jul 2025.
- Derived from this study: PubMed 42098721Ismail RM, Abdelhamed IM, Samir W, Alryess AM, El-Mahallawy Y. Impact of three miniplate configurations on mental nerve integrity in parasymphyseal mandibular fractures: a blinded randomized trial. BMC Oral Health. 2026 May 7;26(1):859. doi: 10.1186/s12903-026-08487-0.
- 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
Related trials for Mandibular Fracture Trauma
Active, not recruiting
3D Printed Models for Mandibular Fracture Repair
Mandible Fracture, Maxillofacial Trauma
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 Twinfork plate, 3D-interlocking plate and Miniplate in people with Mandibular Fracture Trauma and Mandible 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 10 Jul 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.
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?
Sensory nerve function (time frame: 6 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 NCT07058597, 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 10 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.