Mandibular FracturesNCT07094867
Customized z Shaped Miniplate Versus Standard 2 Miniplates for Fixation of Parasymphyseal/Body Mandibular Fractures
A study testing customized Z shaped miniplate and conventional two miniplates in people with Mandibular Fractures, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Mandibular fractures are a common type of facial fractures. The surgical treatment has developed over the years due to improved understanding of biomechanics, biomaterials and scientifically based treatment outcomes. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- customized Z shaped miniplate and conventional two miniplates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 30 Dec 2024
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients suffering from recent fractures at the parasymphysis/body of the mandible presented within 2 weeks of the date of trauma.
- Radiographic evidence of parasymphyseal/body mandibular fracture that demands open reduction and internal fixation.
- The patient is medically fit for general anesthesia
Who cannot join
- comminuted fracture.
- Pathological fracture.
- Presence of infection
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria
About this study
Official title: Customized z Shaped Miniplate Versus Standard 2 Miniplates for Fixation of Parasymphyseal/Body Mandibular Fractures (a Randomized Controlled Clinical Trial)
Mandibular fractures are a common type of facial fractures. The surgical treatment has developed over the years due to improved understanding of biomechanics, biomaterials and scientifically based treatment outcomes. since customized fixation mechanism is more suited to the bone surface which helps to meet the requirements of a semirigid fixation. Customized Z plate is a new geometry of miniplates that may provide superior preservation of mental nerve, stability, support and easier in adaptation compared to the standard 2 miniplates system for fixation of parasymhyseal/body mandibular fractures.
- Conditions
- Mandibular Fractures
- Being tested
- customized Z shaped miniplate, conventional two miniplates
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
customized Z shaped miniplateOther
Planning was done using Mimics Innovation Suite 15.0 software for surgical planning, surgical simulation, and modeling of a custom-made Z-pattern plate installed on a standard personal computer system. The milling of a plate design on a titanium block was be done.
conventional two miniplatesOther
Mobilization of the fracture, removal of any soft tissue entrapped within the fracture line, and management of teeth in the fracture line, either by extraction or preservation. Followed by bone reduction into proper anatomical occlusion. Then conventional two miniplates was used according to Champy's osteosynthesis lines
| Study group | Role | What they receive |
|---|---|---|
| Test Group "Customzied z Plate" | Experimental | Not described Receives: Other: customized Z shaped miniplate |
| Conventional treatment "Miniplates" | Active comparator | Not described Receives: Other: conventional two miniplates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores
Patient asked to identify his pain sensation through a 10-point visual analogue scale (VAS) and the level of pain will be interpreted as (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
Measured: after 24-hours, one week, four weeks and six weeks
Presence of intra-fragmentary mobility
The mobility assessed by bi-manual palpation across the fracture site.
Measured: up to 6 weeks
Change in bone density
Immediate CBCT scan will be used to assess the adequacy of fracture line reduction and fixation, and then another will be taken at 6th month to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan
Measured: baseline and 6 months
Secondary outcomes (1)
Change in sensory nerve function
Presecne of alteration in sensation in lower lip and mental area (Yes/No)
Measured: after 24-hours, one week, four weeks and six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Apr 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094867
- Sponsor's protocol ID
- 0866-02/2024
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abd El Hamid MA, El Mahallawy AS, Saber ME. Accuracy of reduction and postoperative symmetry assessment of customized z-shaped miniplates versus conventional miniplates in mandibular fractures treatment: a randomized controlled clinical trial. BMC Oral Health. 2026 May 18;26(1):906. doi: 10.1186/s12903-026-08555-5.
PubMed 42151958Abd El Hamid MA, El Mahallawy AS, Elshatby NM, Saber ME. Customized z-shaped versus conventional miniplates for fixation of parasymphyseal/body mandibular fractures: a randomized controlled trial evaluating clinical and radiographic outcomes. BMC Oral Health. 2026 Feb 2;26(1):415. doi: 10.1186/s12903-026-07671-6.
PubMed 41622154
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized z Shaped Miniplate Versus Standard 2 Miniplates for Fixation of Parasymphyseal/Body Mandibular Fractures (a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07094867
- Acronym / sponsor ID
- 0866-02/2024
- Conditions
- Mandibular Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 30 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.
Mandibular fractures are a common type of facial fractures. The surgical treatment has developed over the years due to improved understanding of biomechanics, biomaterials and scientifically based treatment outcomes. since customized fixation mechanism is more suited to the bone surface which helps to meet the requirements of a semirigid fixation. Customized Z plate is a new geometry of miniplates that may provide superior preservation of mental nerve, stability, support and easier in adaptation compared to the standard 2 miniplates system for fixation of parasymhyseal/body mandibular fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group "Customzied z Plate" | Experimental | Other: customized Z shaped miniplate |
| Conventional treatment "Miniplates" | Active comparator | Other: conventional two miniplates |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients suffering from recent fractures at the parasymphysis/body of the mandible presented within 2 weeks of the date of trauma.
- Radiographic evidence of parasymphyseal/body mandibular fracture that demands open reduction and internal fixation.
- The patient is medically fit for general anesthesia
Key exclusion criteria (3 listed)
- comminuted fracture.
- Pathological fracture.
- Presence of 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 |
|---|---|---|
| customized Z shaped miniplatePlanning was done using Mimics Innovation Suite 15.0 software for surgical planning, surgical simulation, and modeling of a custom-made Z-pattern plate installed on a standard personal computer system. The milling of a plate design on a titanium block was be done. | Other | Test Group "Customzied z Plate" |
| conventional two miniplatesMobilization of the fracture, removal of any soft tissue entrapped within the fracture line, and management of teeth in the fracture line, either by extraction or preservation. Followed by bone reduction into proper anatomical occlusion. Then conventional two miniplates was used according to Champy's osteosynthesis lines | Other | Conventional treatment "Miniplates" |
Primary outcome
Change in pain scores
Time frame: after 24-hours, one week, four weeks and six weeks
Patient asked to identify his pain sensation through a 10-point visual analogue scale (VAS) and the level of pain will be interpreted as (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
Presence of intra-fragmentary mobility
Time frame: up to 6 weeks
The mobility assessed by bi-manual palpation across the fracture site.
Change in bone density
Time frame: baseline and 6 months
Immediate CBCT scan will be used to assess the adequacy of fracture line reduction and fixation, and then another will be taken at 6th month to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan
1 secondary outcome
Change in sensory nerve function
Time frame: after 24-hours, one week, four weeks and 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 30 Jul 2025.
- Derived from this study: PubMed 42151958Abd El Hamid MA, El Mahallawy AS, Saber ME. Accuracy of reduction and postoperative symmetry assessment of customized z-shaped miniplates versus conventional miniplates in mandibular fractures treatment: a randomized controlled clinical trial. BMC Oral Health. 2026 May 18;26(1):906. doi: 10.1186/s12903-026-08555-5.
- Derived from this study: PubMed 41622154Abd El Hamid MA, El Mahallawy AS, Elshatby NM, Saber ME. Customized z-shaped versus conventional miniplates for fixation of parasymphyseal/body mandibular fractures: a randomized controlled trial evaluating clinical and radiographic outcomes. BMC Oral Health. 2026 Feb 2;26(1):415. doi: 10.1186/s12903-026-07671-6.
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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 study testing customized Z shaped miniplate and conventional two miniplates in people with Mandibular Fractures, run by Hams Hamed Abdelrahman 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 3 inclusion and 3 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 30 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?
Change in pain scores (time frame: after 24-hours, one week, four weeks and six weeks). The study lists 3 primary outcomes in all. 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 NCT07094867, which also lists 2 linked publications.
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 30 Jul 2025.