Mandibular FracturesNCT07850570
Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates
A study testing Custom-Made Titanium Plate and Custom-Made PEEK Plate in people with Mandibular Fractures, run by Mansoura University at 1 site in Egypt.
Trial summary
Mandibular fractures represent a significant portion of maxillofacial trauma, primarily resulting from motor vehicle accidents, interpersonal violence, and sports-related injuries. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Custom-Made Titanium Plate and Custom-Made PEEK Plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Sep 2026to 24 Sep 2028
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients age ranging from 18 to 50 years.
- Unilateral and/or bilateral simple or compound fractures of the mandibular symphysis, parasymphysis or body regions that are displaced and require open reduction with internal fixation.
- The fractures must be recent, having occurred no longer than 10 days prior to the surgical treatment.
- Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I.
Who cannot join
- Patients suffer from pathological fractures.
- Comminuted and infected fractures.
- Fracture of the atrophic edentulous ridge
- Old mandibular fractures (more than 10 days).
- Patients with ASA classes II, III, IV, and V.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University, Faculty of Dentistry
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates for Fixation of Mandibular Fractures
Mandibular fractures represent a significant portion of maxillofacial trauma, primarily resulting from motor vehicle accidents, interpersonal violence, and sports-related injuries. Achieving successful treatment requires accurate anatomical reduction, stable internal fixation, and restoration of pre-traumatic occlusion and masticatory function . Open reduction and internal fixation (ORIF) using titanium miniplates has long served as the gold standard for mandibular fracture management due to their superior mechanical strength, excellent biocompatibility, and proven structural reliability .
Despite their widespread clinical adoption, conventional titanium plates present notable drawbacks. Their high elastic modulus compared to human cortical bone often leads to stress shielding, which can impede normal bone healing and cause local osteopenia .Additionally, titanium hardware can cause temperature sensitivity, scatter artifacts on computed tomography (CT) and magnetic resonance imaging (MRI) scans, and may necessitate secondary surgical removal due to palpability or infection .
Read more
To address these limitations, Polyether Ether Ketone (PEEK)-a high-performance thermoplastic polymer has emerged as a promising alternative biomaterial in maxillofacial surgery. PEEK exhibits an elastic modulus close to natural bone, thereby reducing stress shielding and promoting physiological strain distribution during fracture healing. Furthermore, PEEK is radiolucent, non-magnetic, and chemically inert, allowing artifact-free postoperative radiologic assessment .
With advancements in digital dentistry, computer-aided design and computer-aided manufacturing (CAD/CAM) alongside 3D printing have enabled the fabrication of patient-specific, custom-made implants. Custom-made titanium and PEEK plates eliminate the need for intraoperative manual bending, significantly reducing surgical time, improving contour accuracy, and enhancing mechanical stability across the fracture site . While custom-made titanium provides rigid fixation suitable for high-load zones, custom-made PEEK implants offer an biomechanically compatible and artifact-free alternative.
However, direct comparative clinical and biomechanical evaluations between custom-made titanium and custom-made PEEK plates for mandibular fracture fixation remain limited. Therefore, this study aimed to evaluate and compare the clinical outcome, stability, and surgical efficiency of custom-made titanium versus custom-made PEEK plates in the fixation of mandibular fractures.
Read the detailed description
Maxillofacial trauma is the most common cause of facial injuries resulting from various causes such as road traffic accidents, accidental falls, assaults, industrial mishaps, sports injuries and firearm injuries. The severity and pattern of maxillofacial trauma depend on the anatomic site, magnitude, and the direction of the force delivered to the face.
Reconstruction of facial bones following traumatic events represents one of the greatest challenges to maxillofacial surgeons. The role of the mandible is crucial in maintaining facial esthetics and functional occlusion. Due to its prominence and mobility, mandibular fractures represent the most common facial fractures, accounting for approximately 59% of all maxillofacial fractures.
Treatment modalities for mandibular fractures include closed reduction with intermaxillary fixation, open reduction with wire osteosynthesis and open reduction with rigid fixation. With modern surgical advances, modalities for the treatment of mandibular fracture depending on scientific facilities have been directed to facilitate the need of early, preferably and immediate mobilization in order to reduce the need of maxillomandibular fixation (MMF).
Whereas MMF is to blame for impairing the oral hygiene, masticatory efficiency and mouth opening besides it causes pain, phonetic disturbance and weight loss. Mandibular fractures are ideally treated with open reduction and internal fixation by an intraoral or extraoral approach. Direct bone contact between the fracture segments supports primary bone healing, that results in earlier bone regrowth and stability across the fracture site.
Nowadays, computers are being extensively used not only for diagnosis but also for designing surgical procedures in the craniomaxillofacial field. Advances in virtual surgery, 3D printing and milling techniques have significantly increased surgical precision and efficiency. These advances can be utilized alongside digital imaging techniques like computerized tomography (CT) to generate custom-made plates specifically tailored for each fracture. This can serve to shorten the operation time, eliminate the need to remove the plates and improve fixation system stability. The possibility of generating a three-dimensional model from CT scans was first mentioned in 19870.
Many materials can be employed in the process of manufacturing these custom-made plates like titanium, which is the most common conventional used type and Polyether ether ketone (PEEK) being a recent alternative.
PEEK is a linear semi-crystalline poly-aromatic polymer which has dimensional properties close to that of living bone in terms of strength and stiffness. The major beneficial property of PEEK is its lower Young's modulus of elasticity which is close to that of the cortical bone and therefore, it is likely to eliminate the major problem encountered with titanium plating system which is the stress shielding phenomenon. It is highly durable, resists a high degree of temperature greater than 300 degrees Celsius and can be used without adverse tissue effects. This study aims to evaluate the use of custom-made titanium plates versus PEEK plates in the treatment of mandibular fractures.
The null hypothesis states that there is no significant difference in clinical and radiographic outcomes between custom-made titanium plates and custom-made PEEK plates for fixation of mandibular fractures.
- Conditions
- Mandibular Fractures
- Being tested
- Custom-Made Titanium Plate, Custom-Made PEEK Plate
- Keywords
- PEEK plates-Titanium plates-mandibular fracture
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-Made Titanium PlateDevice
Custom-made titanium plate used for fixation of mandibular fractures.
Custom-Made PEEK PlateDevice
Custom-made polyether ether ketone (PEEK) plate used for fixation of mandibular fractures.
| Study group | Role | What they receive |
|---|---|---|
| Custom-Made Titanium Plate | Experimental | Custom-Made Titanium Plate for Fixation of Mandibular Fractures Receives: Device: Custom-Made Titanium Plate |
| Custom-Made PEEK Plate | Experimental | Custom-made polyether ether ketone (PEEK) plate used for fixation of mandibular fractures. Receives: Device: Custom-Made PEEK Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with adequate reduction of the fractured segment
will be determined by an assessment of the inferior border of the mandible as follows:
- Excellent reduction: whenever alignment of the inferior border of mandible will be maintained across the fracture line.
- Good reduction: if a discrepancy of 1-3 mm is noted.
- Fair reduction: if a discrepancy of 3-5mm is noted.
- Poor reduction: if the discrepancy is > 5 mm.
Measured: immediately and 6 months after the surgery consequently
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start24 Sep 2026 (estimated)
- Primary completion24 Mar 2027 (estimated)
- Study completion24 Sep 2028 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aya ali Elsies, assistant lecturer, Principal investigator, Faculty of Dentistry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850570
- Sponsor's protocol ID
- MDP.26.08.38
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 9 Oct 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates for Fixation of Mandibular Fractures
- ClinicalTrials.gov ID
- NCT07850570
- Acronym / sponsor ID
- MDP.26.08.38
- Conditions
- Mandibular Fractures
- Keywords
- PEEK plates-Titanium plates-mandibular fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 24 Sep 2026 (estimated)
- Primary completion
- 24 Mar 2027 (estimated)
- Study completion
- 24 Sep 2028 (estimated)
- First posted
- 30 Sep 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.
Mandibular fractures represent a significant portion of maxillofacial trauma, primarily resulting from motor vehicle accidents, interpersonal violence, and sports-related injuries. Achieving successful treatment requires accurate anatomical reduction, stable internal fixation, and restoration of pre-traumatic occlusion and masticatory function . Open reduction and internal fixation (ORIF) using titanium miniplates has long served as the gold standard for mandibular fracture management due to their superior mechanical strength, excellent biocompatibility, and proven structural reliability .
Despite their widespread clinical adoption, conventional titanium plates present notable drawbacks. Their high elastic modulus compared to human cortical bone often leads to stress shielding, which can impede normal bone healing and cause local osteopenia .Additionally, titanium hardware can cause temperature sensitivity, scatter artifacts on computed tomography (CT) and magnetic resonance imaging (MRI) scans, and may necessitate secondary surgical removal due to palpability or infection .
To address these limitations, Polyether Ether Ketone (PEEK)-a high-performance thermoplastic polymer has emerged as a promising alternative biomaterial in maxillofacial surgery. PEEK exhibits an elastic modulus close to natural bone, thereby reducing stress shielding and promoting physiological strain distribution during fracture healing. Furthermore, PEEK is radiolucent, non-magnetic, and chemically inert, allowing artifact-free postoperative radiologic assessment .
With advancements in digital dentistry, computer-aided design and computer-aided manufacturing (CAD/CAM) alongside 3D printing have enabled the fabrication of patient-specific, custom-made implants. Custom-made titanium and PEEK plates eliminate the need for intraoperative manual bending, significantly reducing surgical time, improving contour accuracy, and enhancing mechanical stability across the fracture site . While custom-made titanium provides rigid fixation suitable for high-load zones, custom-made PEEK implants offer an biomechanically compatible and artifact-free alternative.
However, direct comparative clinical and biomechanical evaluations between custom-made titanium and custom-made PEEK plates for mandibular fracture fixation remain limited. Therefore, this study aimed to evaluate and compare the clinical outcome, stability, and surgical efficiency of custom-made titanium versus custom-made PEEK plates in the fixation of mandibular fractures.
Detailed description
Maxillofacial trauma is the most common cause of facial injuries resulting from various causes such as road traffic accidents, accidental falls, assaults, industrial mishaps, sports injuries and firearm injuries. The severity and pattern of maxillofacial trauma depend on the anatomic site, magnitude, and the direction of the force delivered to the face.
Reconstruction of facial bones following traumatic events represents one of the greatest challenges to maxillofacial surgeons. The role of the mandible is crucial in maintaining facial esthetics and functional occlusion. Due to its prominence and mobility, mandibular fractures represent the most common facial fractures, accounting for approximately 59% of all maxillofacial fractures.
Treatment modalities for mandibular fractures include closed reduction with intermaxillary fixation, open reduction with wire osteosynthesis and open reduction with rigid fixation. With modern surgical advances, modalities for the treatment of mandibular fracture depending on scientific facilities have been directed to facilitate the need of early, preferably and immediate mobilization in order to reduce the need of maxillomandibular fixation (MMF).
Whereas MMF is to blame for impairing the oral hygiene, masticatory efficiency and mouth opening besides it causes pain, phonetic disturbance and weight loss. Mandibular fractures are ideally treated with open reduction and internal fixation by an intraoral or extraoral approach. Direct bone contact between the fracture segments supports primary bone healing, that results in earlier bone regrowth and stability across the fracture site.
Nowadays, computers are being extensively used not only for diagnosis but also for designing surgical procedures in the craniomaxillofacial field. Advances in virtual surgery, 3D printing and milling techniques have significantly increased surgical precision and efficiency. These advances can be utilized alongside digital imaging techniques like computerized tomography (CT) to generate custom-made plates specifically tailored for each fracture. This can serve to shorten the operation time, eliminate the need to remove the plates and improve fixation system stability. The possibility of generating a three-dimensional model from CT scans was first mentioned in 19870.
Many materials can be employed in the process of manufacturing these custom-made plates like titanium, which is the most common conventional used type and Polyether ether ketone (PEEK) being a recent alternative.
PEEK is a linear semi-crystalline poly-aromatic polymer which has dimensional properties close to that of living bone in terms of strength and stiffness. The major beneficial property of PEEK is its lower Young's modulus of elasticity which is close to that of the cortical bone and therefore, it is likely to eliminate the major problem encountered with titanium plating system which is the stress shielding phenomenon. It is highly durable, resists a high degree of temperature greater than 300 degrees Celsius and can be used without adverse tissue effects. This study aims to evaluate the use of custom-made titanium plates versus PEEK plates in the treatment of mandibular fractures.
The null hypothesis states that there is no significant difference in clinical and radiographic outcomes between custom-made titanium plates and custom-made PEEK plates for fixation of mandibular fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom-Made Titanium Plate | Experimental | Device: Custom-Made Titanium PlateCustom-Made Titanium Plate for Fixation of Mandibular Fractures |
| Custom-Made PEEK Plate | Experimental | Device: Custom-Made PEEK PlateCustom-made polyether ether ketone (PEEK) plate used for fixation of mandibular fractures. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients age ranging from 18 to 50 years.
- Unilateral and/or bilateral simple or compound fractures of the mandibular symphysis, parasymphysis or body regions that are displaced and require open reduction with internal fixation.
- The fractures must be recent, having occurred no longer than 10 days prior to the surgical treatment.
- Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I.
Key exclusion criteria (5 listed)
- Patients suffer from pathological fractures.
- Comminuted and infected fractures.
- Fracture of the atrophic edentulous ridge
- Old mandibular fractures (more than 10 days).
- Patients with ASA classes II, III, IV, and V.
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 |
|---|---|---|
| Custom-Made Titanium PlateCustom-made titanium plate used for fixation of mandibular fractures. | Device | Custom-Made Titanium Plate |
| Custom-Made PEEK PlateCustom-made polyether ether ketone (PEEK) plate used for fixation of mandibular fractures. | Device | Custom-Made PEEK Plate |
Primary outcome
number of patients with adequate reduction of the fractured segment
Time frame: immediately and 6 months after the surgery consequently
will be determined by an assessment of the inferior border of the mandible as follows: 1. Excellent reduction: whenever alignment of the inferior border of mandible will be maintained across the fracture line. 2. Good reduction: if a discrepancy of 1-3 mm is noted. 3. Fair reduction: if a discrepancy of 3-5mm is noted. 4. Poor reduction: if the discrepancy is > 5 mm.
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 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Mandibular Fractures
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Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
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Bony Overlap Following Use of the Inferior Border Saw for the 'Low and Short' Sagittal Split: A Split-Mouth Study
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Virtual Surgical Planning and Preoperative Plate Bending for Maxillofacial Fractures
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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.
Aya ali Elsies, assistant lecturer principal investigator
Faculty of Dentistry, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom-Made Titanium Plate and Custom-Made PEEK Plate in people with Mandibular Fractures, run by Mansoura 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 5 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: looking for participants now, as of the sponsor's last update on 9 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 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?
Contact aya ali Elsies, assistant lecturer (0201091797600, ayaalialsies@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with adequate reduction of the fractured segment (time frame: immediately and 6 months after the surgery consequently). 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 9 Oct 2026.