Mandibular FracturesNCT07901686
Z-Shaped Versus Conventional Miniplates for Mandibular Fractures
A study testing Z-shaped titanium miniplate and Conventional titanium miniplates in people with Mandibular Fractures, run by Sana'a University at 2 sites in Yemen.
Trial summary
This study compares two different methods of repairing fractures at the front of the lower jaw (the symphysis and parasymphysis). Usually, surgeons fix these displaced fractures using two separate titanium plates, which can be time-consuming to place and lie close to the nerve that supplies feeling to the lower lip… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Z-shaped titanium miniplate and Conventional titanium miniplates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesYemen
- Study dates
- 25 Sep 2025to 7 Jun 2026
- 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
- Fracture of the symphyseal or parasymphyseal region of the mandible.
- Medical fitness for surgery under general anesthesia.
- Displaced fracture.
- Age 18 years or older.
Who cannot join
- Edentulous patients.
- Comminuted, infected, or pathological fractures.
- Mandibular fractures associated with condylar fractures.
- Age below 18 years.
Trial locations and contacts
2 sites in 1 country.
Yemen2 sites
Al-Gumhouri Teaching Hospital
Sanaa
Al-Kuwait University Hospital
Sanaa
About this study
Official title: Z-shaped Miniplate Versus Conventional Two-miniplate Fixation of Symphyseal and Parasymphyseal Mandibular Fractures: a Prospective Comparative Study.
This study compares two different methods of repairing fractures at the front of the lower jaw (the symphysis and parasymphysis). Usually, surgeons fix these displaced fractures using two separate titanium plates, which can be time-consuming to place and lie close to the nerve that supplies feeling to the lower lip and chin. Recently, a single Z-shaped titanium plate was designed to provide the same stability using less hardware, potentially making the surgery easier and safer for the nerve.
The purpose of this study is to compare the use of a single Z-shaped miniplate with the conventional two-miniplate technique in adult patients. The researchers will measure how long the surgery takes, the number of screws needed, and how easy it is to place the plates. After the surgery, patients will be monitored for up to 3 months to compare pain levels, facial swelling, jaw movement (mouth opening and side-to-side movement), nerve function, and how well the bone heals on x-rays.
Read the detailed description
The mandibular symphysis and parasymphysis are exposed to strong bending and twisting forces during function, meaning a single conventional miniplate is usually insufficient to neutralize forces and prevent the inner surface of the bone from opening under muscle pull. The accepted standard for semirigid fixation is two miniplates. However, this technique requires wider surgical exposure, separate contouring of two plates, and carries a risk of nerve injury due to the proximity of the mental foramen. While closed three-dimensional (3D) plates offer cross-bracing with a single implant, they can be difficult to adapt around the mental nerve. The Z-shaped miniplate features two parallel bars joined by an oblique bar; its open edges allow placement without trapping the nerve.
This prospective, quasi-randomised comparative study is conducted at Al-Kuwait University Hospital and Al-Gumhouri Teaching Hospital in Sana'a, Yemen. It aims to evaluate the operative, clinical, and radiographic outcomes of a single Z-shaped miniplate versus two conventional miniplates. Patients undergo open reduction and internal fixation under general anesthesia using a standardized surgical protocol. Clinical follow-up is conducted on postoperative days 1, 2, and 7 to assess pain via visual analogue scale, facial swelling via linear tape measurements, maximum interincisal opening, lateral excursion, and neurosensory status. Radiographic reduction and residual fracture gaps are evaluated via computed tomography or panoramic radiography at 7 days and 3 months postoperatively.
- Conditions
- Mandibular Fractures
- Being tested
- Z-shaped titanium miniplate, Conventional titanium miniplates
- Keywords
- Mandibular Fractures, Miniplate, Z-shaped plate, Internal fixation, Symphysis, Parasymphysis
- 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-shaped titanium miniplateDevice
Open reduction and internal fixation of the mandibular fracture using a single Z-shaped titanium miniplate
Conventional titanium miniplatesDevice
Open reduction and internal fixation of the mandibular fracture using two 5-hole non-compression titanium miniplates.
| Study group | Role | What they receive |
|---|---|---|
| Z-shaped miniplate | Experimental | Patients in this group undergo fixation of the mandibular fracture using a single Z-shaped titanium miniplate. Receives: Device: Z-shaped titanium miniplate |
| Conventional miniplates | Active comparator | Patients in this group undergo fixation of the mandibular fracture using two conventional 5-hole non-compression titanium miniplates. Receives: Device: Conventional titanium miniplates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Evaluation of Fracture Reduction
Assessment of fracture reduction, hardware stability, and residual fracture gaps evaluated via computed tomography (CT) or panoramic radiography.
Measured: 7 days and 3 months postoperatively.
Secondary outcomes (5)
Operative Time
The total surgical time required for plate adaptation, placement, and screw fixation, measured in minutes.
Measured: Intraoperative
Postoperative Pain
Patient-reported pain intensity assessed using a standard Visual Analogue Scale (VAS).
Measured: Postoperative days 1, 2, and 7.
Facial Swelling
Postoperative edema evaluated using objective linear tape measurements between standard facial landmarks.
Measured: Postoperative days 1, 2, and 7.
Maximum Interincisal Opening (MIO) and Lateral Excursion
Measurement of maximum mouth opening and side-to-side jaw movement in millimeters to assess functional recovery.
Measured: Postoperative days 1, 2, and 7.
Neurosensory Status
Clinical assessment of the mental nerve function (e.g., using light touch or pinprick testing) to evaluate for potential iatrogenic nerve injury.
Measured: Postoperative days 1, 2, and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start25 Sep 2025
- Primary completion15 Feb 2026
- Study completion7 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular FracturesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were allocated by an alternating (odd/even) enrollment number sequence to receive either a single Z-shaped miniplate or two conventional miniplates.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Al-Maqaleh, Sana'a University
- Investigators
- Sam Da'er, Associate Professor, Study chair, Sana'a University, Oral and Maxillofacial Surgery DepartmentMostafeed Bajjash, MSc, Principal investigator, Sana'a University, Oral and Maxillofacial Surgery DepartmentMohammed Al-Maqaleh, Principal investigator, Sana'a University, Oral and Maxillofacial Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901686
- Sponsor's protocol ID
- OMFS:06.09.2025
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient confidentiality and privacy. All relevant data supporting the findings and conclusions of this study will be made available in aggregate form within the published manuscript and its supplementary materials.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Z-shaped Miniplate Versus Conventional Two-miniplate Fixation of Symphyseal and Parasymphyseal Mandibular Fractures: a Prospective Comparative Study.
- ClinicalTrials.gov ID
- NCT07901686
- Acronym / sponsor ID
- OMFS:06.09.2025
- Conditions
- Mandibular Fractures
- Keywords
- Mandibular Fractures, Miniplate, Z-shaped plate, Internal fixation, Symphysis, Parasymphysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 7 Jun 2026 (actual)
- First posted
- 28 Oct 2026 (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.
This study compares two different methods of repairing fractures at the front of the lower jaw (the symphysis and parasymphysis). Usually, surgeons fix these displaced fractures using two separate titanium plates, which can be time-consuming to place and lie close to the nerve that supplies feeling to the lower lip and chin. Recently, a single Z-shaped titanium plate was designed to provide the same stability using less hardware, potentially making the surgery easier and safer for the nerve.
The purpose of this study is to compare the use of a single Z-shaped miniplate with the conventional two-miniplate technique in adult patients. The researchers will measure how long the surgery takes, the number of screws needed, and how easy it is to place the plates. After the surgery, patients will be monitored for up to 3 months to compare pain levels, facial swelling, jaw movement (mouth opening and side-to-side movement), nerve function, and how well the bone heals on x-rays.
Detailed description
The mandibular symphysis and parasymphysis are exposed to strong bending and twisting forces during function, meaning a single conventional miniplate is usually insufficient to neutralize forces and prevent the inner surface of the bone from opening under muscle pull. The accepted standard for semirigid fixation is two miniplates. However, this technique requires wider surgical exposure, separate contouring of two plates, and carries a risk of nerve injury due to the proximity of the mental foramen. While closed three-dimensional (3D) plates offer cross-bracing with a single implant, they can be difficult to adapt around the mental nerve. The Z-shaped miniplate features two parallel bars joined by an oblique bar; its open edges allow placement without trapping the nerve.
This prospective, quasi-randomised comparative study is conducted at Al-Kuwait University Hospital and Al-Gumhouri Teaching Hospital in Sana'a, Yemen. It aims to evaluate the operative, clinical, and radiographic outcomes of a single Z-shaped miniplate versus two conventional miniplates. Patients undergo open reduction and internal fixation under general anesthesia using a standardized surgical protocol. Clinical follow-up is conducted on postoperative days 1, 2, and 7 to assess pain via visual analogue scale, facial swelling via linear tape measurements, maximum interincisal opening, lateral excursion, and neurosensory status. Radiographic reduction and residual fracture gaps are evaluated via computed tomography or panoramic radiography at 7 days and 3 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were allocated by an alternating (odd/even) enrollment number sequence to receive either a single Z-shaped miniplate or two conventional miniplates.
| Arm | Type | Receives |
|---|---|---|
| Z-shaped miniplate | Experimental | Device: Z-shaped titanium miniplatePatients in this group undergo fixation of the mandibular fracture using a single Z-shaped titanium miniplate. |
| Conventional miniplates | Active comparator | Device: Conventional titanium miniplatesPatients in this group undergo fixation of the mandibular fracture using two conventional 5-hole non-compression titanium 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)
- Fracture of the symphyseal or parasymphyseal region of the mandible.
- Medical fitness for surgery under general anesthesia.
- Displaced fracture.
- Age 18 years or older.
Key exclusion criteria (4 listed)
- Edentulous patients.
- Comminuted, infected, or pathological fractures.
- Mandibular fractures associated with condylar fractures.
- Age below 18 years.
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-shaped titanium miniplateOpen reduction and internal fixation of the mandibular fracture using a single Z-shaped titanium miniplate | Device | Z-shaped miniplate |
| Conventional titanium miniplatesOpen reduction and internal fixation of the mandibular fracture using two 5-hole non-compression titanium miniplates. | Device | Conventional miniplates |
Primary outcome
Radiographic Evaluation of Fracture Reduction
Time frame: 7 days and 3 months postoperatively.
Assessment of fracture reduction, hardware stability, and residual fracture gaps evaluated via computed tomography (CT) or panoramic radiography.
5 secondary outcomes
Operative Time
Time frame: Intraoperative
Postoperative Pain
Time frame: Postoperative days 1, 2, and 7.
Facial Swelling
Time frame: Postoperative days 1, 2, and 7.
Maximum Interincisal Opening (MIO) and Lateral Excursion
Time frame: Postoperative days 1, 2, and 7.
Neurosensory Status
Time frame: Postoperative days 1, 2, and 7.
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 28 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient confidentiality and privacy. All relevant data supporting the findings and conclusions of this study will be made available in aggregate form within the published manuscript and its supplementary materials.
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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.
Sam Da'er, Associate Professor study chair
Sana'a University, Oral and Maxillofacial Surgery Department
Mostafeed Bajjash, MSc principal investigator
Sana'a University, Oral and Maxillofacial Surgery Department
Mohammed Al-Maqaleh principal investigator
Sana'a University, Oral and Maxillofacial Surgery Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Z-shaped titanium miniplate and Conventional titanium miniplates in people with Mandibular Fractures, run by Sana'a University at 2 sites in Yemen.
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 4 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Yemen. 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?
Radiographic Evaluation of Fracture Reduction (time frame: 7 days and 3 months postoperatively.). 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 28 Oct 2026.