Mandible FractureNCT06898710
z Mini-plate With Lingual Extension Versus Conventional 2 Mini Plates
A study testing z mini plate with lingual extension and conventional 2 mini plates in people with Mandible Fracture, run by Fayoum University.
Trial summary
The collected patients according to the eligibility criteria will be randomly distributed into one of these groups: Group I : 10 patients suffering class III mandibular fracture will be managed by patient specific Z shape mini-plate with lingual extension (study group). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mandible Fracture
- What is being tested?
- z mini plate with lingual extension and conventional 2 mini plates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Class III mandibular fracture
- medically stable patient
- aged above 21 years
- no medical condition affect the bone healing
Who cannot join
- • absence of other facial trauma, mandibular condylar fracture
- patient refuse the follow up
About this study
Official title: Evaluating the Efficacy of Patient Specific Z-shape Mini-plate With Lingual Extension Versus Usual Two Mini-plates in Mandibular Class III Fracture Management
The collected patients according to the eligibility criteria will be randomly distributed into one of these groups:
Group I : 10 patients suffering class III mandibular fracture will be managed by patient specific Z shape mini-plate with lingual extension (study group).
Group II : 10 patients suffering class III mandibular fracture will be managed by 2 mini plates at superior and inferior borders (control group).
The allocation sequence will be generated using computerized random numbers and kept in sealed envelopes, which will be opened prior to surgery. All patients will provide the informed consent after declaration the procedures, benefits, and harms
- Conditions
- Mandible Fracture
- Being tested
- z mini plate with lingual extension, conventional 2 mini plates
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
z mini plate with lingual extensionProcedure or surgery
patient with class III mandible fracture will be treated with patient specific z mini plate with lingual extension
conventional 2 mini platesProcedure or surgery
patient with class III mandible fracture will be treated with conventional 2 mini plates
| Study group | Role | What they receive |
|---|---|---|
| z miniplate with lingual extension | Experimental | Not described Receives: Procedure: z mini plate with lingual extension |
| two mini plate | Active comparator | Not described Receives: Procedure: conventional 2 mini plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
inter condylar distance
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 posted27 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandible FractureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898710
- Sponsor's protocol ID
- 4444
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Patient Specific Z-shape Mini-plate With Lingual Extension Versus Usual Two Mini-plates in Mandibular Class III Fracture Management
- ClinicalTrials.gov ID
- NCT06898710
- Acronym / sponsor ID
- 4444
- Conditions
- Mandible Fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Mar 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 collected patients according to the eligibility criteria will be randomly distributed into one of these groups:
Group I : 10 patients suffering class III mandibular fracture will be managed by patient specific Z shape mini-plate with lingual extension (study group).
Group II : 10 patients suffering class III mandibular fracture will be managed by 2 mini plates at superior and inferior borders (control group).
The allocation sequence will be generated using computerized random numbers and kept in sealed envelopes, which will be opened prior to surgery. All patients will provide the informed consent after declaration the procedures, benefits, and harms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| z miniplate with lingual extension | Experimental | Procedure: z mini plate with lingual extension |
| two mini plate | Active comparator | Procedure: conventional 2 mini plates |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Class III mandibular fracture
- medically stable patient
- aged above 21 years
- no medical condition affect the bone healing
Key exclusion criteria (2 listed)
- • absence of other facial trauma, mandibular condylar fracture
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 |
|---|---|---|
| z mini plate with lingual extensionpatient with class III mandible fracture will be treated with patient specific z mini plate with lingual extension | Procedure or surgery | z miniplate with lingual extension |
| conventional 2 mini platespatient with class III mandible fracture will be treated with conventional 2 mini plates | Procedure or surgery | two mini plate |
Primary outcome
inter condylar distance
Time frame: 3 months
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 27 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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 z mini plate with lingual extension and conventional 2 mini plates in people with Mandible Fracture, run by Fayoum 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 2 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 27 Mar 2025. 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?
inter condylar distance (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 27 Mar 2025.