Mandibular Body FracturesNCT07729345
Assessment Polyether Ether Ketone (PEEK) Custom Made Plates Versuscustom Made Titanium Plates in Treatment of Mandibular Body Fractures
A study testing computer-assisted Polyether ether ketone (PEEK) custom made plates in people with Mandibular Body Fractures, run by Cairo University at 1 site in Egypt.
Trial summary
The design of the custom made Plates is customized to meet the individual needs of each patient and surgeon. By selecting plate design features, surgeons can customize the plate to create a patient specific solution. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mandibular Body Fractures
- What is being tested?
- computer-assisted Polyether ether ketone (PEEK) custom made plates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to Aug 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with at least a unilateral body fracture indicated for Open reduction internal fixation.
- --Dentate adult patients.
- All ages and both sexes were included in this study.
Who cannot join
- Patients with systemic disease (may affect normal healing).
- Patients with old and/or mal united fractures (affect accuracy of re-reduced the fractured segments).
- Patients whom cannot tolerate follow up intervals (affect accuracy of study results).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiographic Assessment of Accuracy of Computer-assisted Polyether Ether Ketone (PEEK) Custom Made Plates Versus Computer-assisted Custom Made Titanium Plates in Treatment of Mandibular Body Fractures (A Randomized Clinical Trial)
The design of the custom made Plates is customized to meet the individual needs of each patient and surgeon. By selecting plate design features, surgeons can customize the plate to create a patient specific solution. The Patient Specific Plates are manufactured to the planned patient anatomy, eliminating the time needed for intraoperative adaption and creating a stronger plate with a lower overall profile.
But Custom made plates were made in many materials such as titanium, Vitalium, PEEK, etc In this study we will compare the PEEK one with the titanium one to know which one is better in all aspects and if the PEEK one can overcome the shortcoming of the titanium one or not.
Read the detailed description
In patients with mandibular body fractures, will PEEK custom made plates be more efficient in reduction of body fractures accurately than titanium custom made plates (in terms of radiographic and clinical parameters)?
- Conditions
- Mandibular Body Fractures
- Being tested
- computer-assisted Polyether ether ketone (PEEK) custom made plates
- Keywords
- PEEK, mandibular body fractures, titanium plates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-assisted Polyether ether ketone (PEEK) custom made platesProcedure or surgery
computer-assisted Polyether ether ketone (PEEK) custom made plates in mandibular body fractures management
| Study group | Role | What they receive |
|---|---|---|
| PEEK | Experimental | computer-assisted Polyether ether ketone (PEEK) custom made plates Receives: Procedure: computer-assisted Polyether ether ketone (PEEK) custom made plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic assessment of accuracy in mandibular body fractures management
using Mimics software
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 Jul 2026
- Study start1 Feb 2025
- Primary completion20 Jul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Body FracturesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Mahmoud Awad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729345
- Sponsor's protocol ID
- cairo uniiversity
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Assessment of Accuracy of Computer-assisted Polyether Ether Ketone (PEEK) Custom Made Plates Versus Computer-assisted Custom Made Titanium Plates in Treatment of Mandibular Body Fractures (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07729345
- Acronym / sponsor ID
- cairo uniiversity
- Conditions
- Mandibular Body Fractures
- Keywords
- PEEK, mandibular body fractures, titanium plates
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Jul 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.
The design of the custom made Plates is customized to meet the individual needs of each patient and surgeon. By selecting plate design features, surgeons can customize the plate to create a patient specific solution. The Patient Specific Plates are manufactured to the planned patient anatomy, eliminating the time needed for intraoperative adaption and creating a stronger plate with a lower overall profile.
But Custom made plates were made in many materials such as titanium, Vitalium, PEEK, etc In this study we will compare the PEEK one with the titanium one to know which one is better in all aspects and if the PEEK one can overcome the shortcoming of the titanium one or not.
Detailed description
In patients with mandibular body fractures, will PEEK custom made plates be more efficient in reduction of body fractures accurately than titanium custom made plates (in terms of radiographic and clinical parameters)?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEEK | Experimental | Procedure: computer-assisted Polyether ether ketone (PEEK) custom made platescomputer-assisted Polyether ether ketone (PEEK) custom made plates |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with at least a unilateral body fracture indicated for Open reduction internal fixation.
- --Dentate adult patients.
- All ages and both sexes were included in this study.
Key exclusion criteria (3 listed)
- Patients with systemic disease (may affect normal healing).
- Patients with old and/or mal united fractures (affect accuracy of re-reduced the fractured segments).
- Patients whom cannot tolerate follow up intervals (affect accuracy of study results).
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 |
|---|---|---|
| computer-assisted Polyether ether ketone (PEEK) custom made platescomputer-assisted Polyether ether ketone (PEEK) custom made plates in mandibular body fractures management | Procedure or surgery | PEEK |
Primary outcome
radiographic assessment of accuracy in mandibular body fractures management
Time frame: 3 months
using Mimics software
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 Jul 2026.
- Individual participant dataSharing planned: No
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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 computer-assisted Polyether ether ketone (PEEK) custom made plates in people with Mandibular Body Fractures, run by Cairo 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 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: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. 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?
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?
radiographic assessment of accuracy in mandibular body fractures management (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 Jul 2026.