Mandibular Body FractureNCT07651059
3D Titanium Plates for Mandibular Body Fracture Fixation
A study testing 3D Titanium Plates in people with Mandibular Body Fracture, run by Cairo University at 1 site in Egypt.
Trial summary
Mandibular body fracture pose significant challenges in maxillofacial surgery due to their frequency, potential for functional impairment, and aesthetic concerns. Open reduction and internal fixation (ORIF) using titanium plates and screws have revolutionized the management of mandibular fractures. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Body Fracture
- What is being tested?
- 3D Titanium Plates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 15 Feb 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ranging between 20-60 years.
- Patients with mandibular body fractures requiring open reduction and fixation.
- Patients with good health (ASA-I and ASA-II) without any contraindication for surgery or anesthesia.
Who cannot join
- Patients with pre-existing neurological or musculoskeletal disease.
- Patients with infected fractures.
- Patients with simultaneous condylar fracture.
- Patients with regional malignancy.
- Medically compromised patients.
- Patients with blood diseases or severe renal disorders. Patients refuse to share in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of 3d Titanium Plates With Two Different Profile Thickness for Open Reduction and Rigid Fixation of Mandibular Body Fracture : Randomised Clinical Trial
Mandibular body fracture pose significant challenges in maxillofacial surgery due to their frequency, potential for functional impairment, and aesthetic concerns. Open reduction and internal fixation (ORIF) using titanium plates and screws have revolutionized the management of mandibular fractures.
Recent advancements in technology have led to the development of patient-specific 3D titanium implants, offering the potential for improved anatomical fit and stability. Moreover, the concept of low-profile implants has gained traction, aiming to minimize soft tissue irritation and enhance patient comfort postoperatively.
Read the detailed description
Facial trauma is common in road traffic accidents (RTA). Due to modernization, increased number of vehicles and failure to follow traffic rules are among various causes of facial trauma. Mandible is one of the frequently fractured bones in RTA. It has been observed that the most common sites of mandibular fracture are angle, body, and ramus.
The incidence of mandibular fracture ranges between 40% and 65% of all facial fractures and so are twice as common as fractures of the midfacial bones. Fractures of the angle of mandible can present with long term disabling sequelae and make up 23%-42% of all fractures in the mandible.
Other than traumatic injuries of the face, there are several factors leading to mandibular body fracture as direct impact or blunt force trauma, indirect trauma to the chin or side of the face, facial fractures, osteoporosis, tumors or cysts in the jawbone, some dental procedures, elderly population, and occupational hazards.
Long term sequel of untreated or poorly treated fractures includes various impairments such as functional, aesthetic, neurological and psychological. The main goal in the treatment of bone fracture is to predictably restore its preinjury anatomical form, with associated aesthetics and function. Techniques for treatment of mandibular fracture have evolved significantly in past decades. These techniques have ranged from closed reduction with maxillomandibular fixation, open reduction with wire osteosynthesis, to open reduction with either rigid internal fixation or adaptive miniplate fixation.
They are best managed by placing one single plate in neutral zone that is sub-apically along with arch bar as tension band. However, in case of severely displaced fractures, inadequate dentition or presence of associated fractures, there are changes in biomechanical vector of forces, which demands for rigid fixation like two plates or load-bearing fixation.
Monocortical plates stabilize the fracture two-dimensionally which can be inadequate fixation in the above-mentioned situations especially in load-bearing area that has led to development of 3D plates. 3D plates are quadrangular in geometry providing stability three-dimensionally due to its design and compact form which counteract against the torsional forces especially in intermental foramen region.
Open reduction and internal fixation (ORIF) using titanium plates and screws have become the standard of care for stabilizing displaced mandibular body fracture, facilitating proper alignment, and promoting optimal healing. However, the optimal design and thickness of these implants remain subjects of debate among maxillofacial surgeons.
- Conditions
- Mandibular Body Fracture
- Being tested
- 3D Titanium Plates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Titanium PlatesDevice
Also called Open Reduction and Rigid Internal Fixation
to compare the 3D titanium plates with two different profile thickness for open reduction and fixation of mandibular body fracture.
| Study group | Role | What they receive |
|---|---|---|
| Group A (3d titanium plates of 2 mm): | Active comparator | About 9 patients suffered from mandibular fracture treated by using 3d titanium plates of 2 mm thickness. Receives: Device: 3D Titanium Plates |
| Group B (3d titanium plates of 0.7 mm): | Active comparator | About 9 patients suffered from mandibular fracture treated by using 3d titanium plates of 0.7 mm thickness. Receives: Device: 3D Titanium Plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Postoperative pain
Treatment of the pain resulted from using 3d titanium plates with two different profile thickness for open reduction and fixation of mandibular body fracture by using a standardized pain scale.
Measured: 48 Hours from the operation
Secondary outcomes (1)
Incidence of postoperative Complications
Secondary outcomes will be evaluated to assess the clinical effectiveness and safety of using 3D titanium plates with different profile thicknesses in the fixation of mandibular body fractures (as infection, malocclusion, and hardware-related complications).
Measured: from1 week to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start15 Dec 2024
- Primary completion15 Dec 2025
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Body FractureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, haitham Aldebass, Cairo University
- Investigators
- Mohamed Atef, Professor, Study chair, of Oral and Maxillofacial Surgery, Faculty of Dentistry - Kasr Al-Aini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651059
- Sponsor's protocol ID
- Mandibular Fracture Fixation
- Status last verified
- Feb 2025
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of 3d Titanium Plates With Two Different Profile Thickness for Open Reduction and Rigid Fixation of Mandibular Body Fracture : Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07651059
- Acronym / sponsor ID
- Mandibular Fracture Fixation
- Conditions
- Mandibular Body Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 16 Jun 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 body fracture pose significant challenges in maxillofacial surgery due to their frequency, potential for functional impairment, and aesthetic concerns. Open reduction and internal fixation (ORIF) using titanium plates and screws have revolutionized the management of mandibular fractures.
Recent advancements in technology have led to the development of patient-specific 3D titanium implants, offering the potential for improved anatomical fit and stability. Moreover, the concept of low-profile implants has gained traction, aiming to minimize soft tissue irritation and enhance patient comfort postoperatively.
Detailed description
Facial trauma is common in road traffic accidents (RTA). Due to modernization, increased number of vehicles and failure to follow traffic rules are among various causes of facial trauma. Mandible is one of the frequently fractured bones in RTA. It has been observed that the most common sites of mandibular fracture are angle, body, and ramus.
The incidence of mandibular fracture ranges between 40% and 65% of all facial fractures and so are twice as common as fractures of the midfacial bones. Fractures of the angle of mandible can present with long term disabling sequelae and make up 23%-42% of all fractures in the mandible.
Other than traumatic injuries of the face, there are several factors leading to mandibular body fracture as direct impact or blunt force trauma, indirect trauma to the chin or side of the face, facial fractures, osteoporosis, tumors or cysts in the jawbone, some dental procedures, elderly population, and occupational hazards.
Long term sequel of untreated or poorly treated fractures includes various impairments such as functional, aesthetic, neurological and psychological. The main goal in the treatment of bone fracture is to predictably restore its preinjury anatomical form, with associated aesthetics and function. Techniques for treatment of mandibular fracture have evolved significantly in past decades. These techniques have ranged from closed reduction with maxillomandibular fixation, open reduction with wire osteosynthesis, to open reduction with either rigid internal fixation or adaptive miniplate fixation.
They are best managed by placing one single plate in neutral zone that is sub-apically along with arch bar as tension band. However, in case of severely displaced fractures, inadequate dentition or presence of associated fractures, there are changes in biomechanical vector of forces, which demands for rigid fixation like two plates or load-bearing fixation.
Monocortical plates stabilize the fracture two-dimensionally which can be inadequate fixation in the above-mentioned situations especially in load-bearing area that has led to development of 3D plates. 3D plates are quadrangular in geometry providing stability three-dimensionally due to its design and compact form which counteract against the torsional forces especially in intermental foramen region.
Open reduction and internal fixation (ORIF) using titanium plates and screws have become the standard of care for stabilizing displaced mandibular body fracture, facilitating proper alignment, and promoting optimal healing. However, the optimal design and thickness of these implants remain subjects of debate among maxillofacial surgeons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (3d titanium plates of 2 mm): | Active comparator | Device: 3D Titanium PlatesAbout 9 patients suffered from mandibular fracture treated by using 3d titanium plates of 2 mm thickness. |
| Group B (3d titanium plates of 0.7 mm): | Active comparator | Device: 3D Titanium PlatesAbout 9 patients suffered from mandibular fracture treated by using 3d titanium plates of 0.7 mm thickness. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ranging between 20-60 years.
- Patients with mandibular body fractures requiring open reduction and fixation.
- Patients with good health (ASA-I and ASA-II) without any contraindication for surgery or anesthesia.
Key exclusion criteria (6 listed)
- Patients with pre-existing neurological or musculoskeletal disease.
- Patients with infected fractures.
- Patients with simultaneous condylar fracture.
- Patients with regional malignancy.
- Medically compromised patients.
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 |
|---|---|---|
| 3D Titanium PlatesAlso: Open Reduction and Rigid Internal Fixationto compare the 3D titanium plates with two different profile thickness for open reduction and fixation of mandibular body fracture. | Device | Group A (3d titanium plates of 2 mm):, Group B (3d titanium plates of 0.7 mm): |
Primary outcome
Treatment of Postoperative pain
Time frame: 48 Hours from the operation
Treatment of the pain resulted from using 3d titanium plates with two different profile thickness for open reduction and fixation of mandibular body fracture by using a standardized pain scale.
1 secondary outcome
Incidence of postoperative Complications
Time frame: from1 week to 6 months
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 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Mandibular Body Fracture
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Assessment Polyether Ether Ketone (PEEK) Custom Made Plates Versuscustom Made Titanium Plates in Treatment of Mandibular Body Fractures
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Efficacy Of Platelet Rich Fibrin (PRF) In Neurosensory Disturbance Among Patients With Mandibular Body 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. This study is not recruiting at the moment.
Mohamed Atef, Professor study chair
of Oral and Maxillofacial Surgery, Faculty of Dentistry - Kasr Al-Aini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Titanium Plates in people with Mandibular Body Fracture, 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 6 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 16 Jun 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?
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?
Treatment of Postoperative pain (time frame: 48 Hours from the operation). 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 16 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.