Fracture MandibleNCT07520227
Comparative Evaluation of 3D-printed (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle
A study testing Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws. and Conventional 3D titanium plates in people with Fracture Mandible, run by Cairo University at 1 site in Egypt.
Trial summary
Is patient specific customized computer assisted 3D PEEK plates more superior to 3D titanium plate in fixation of mandibular angle fractures? Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fracture Mandible
- What is being tested?
- Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws. and Conventional 3D titanium plates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2023to 1 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with mandibular angle fractures indicated for open reduction and internal fixation (ORIF).
- Patients aged 18 years and above.
- Both male and female patients.
- Patients medically fit for surgery under general anesthesia.
- Patients providing informed consent.
Who cannot join
- Patients with pathological fractures.
- Patients with comminuted fractures not suitable for fixation with plates.
- Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
- Patients with a history of previous mandibular surgery in the same region.
- Patients who are unable or unwilling to comply with follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of 3D-printed Polyetheretherketone (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle
Is patient specific customized computer assisted 3D PEEK plates more superior to 3D titanium plate in fixation of mandibular angle fractures?
Read the detailed description
Open Reduction Internal fixation (ORIF) of mandibular angle fractures using titanium plating systems had several drawbacks including sepsis with subsequent wound dehiscence and the need for 2nd surgery which is attributed to bone loss as a result of the elevated modulus of elasticity of titanium hardware. Accordingly, attempts were made to overcome problems encountered with the titanium plating system. In this study, custom made PEEK 3D plates will be used in ORIF of mandibular angle fractures. The main beneficial property of PEEK material is its lower modulus of elasticity that is close to that of living bone with subsequent elimination of the problem of stress shielding phenomenon encountered with titanium plating system. PEEK material has other advantages including biocompatibility, mechanical strength, durability, resistance to high degree of temperature without dimensional alteration.
- Conditions
- Fracture Mandible
- Being tested
- Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws., Conventional 3D titanium plates
- Keywords
- titanium angle fracture mandible
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws.Device
Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws.
Conventional 3D titanium platesDevice
Conventional 3D titanium plates used for fixation of mandibular angle fractures with titanium screws.
| Study group | Role | What they receive |
|---|---|---|
| Computer-assisted PEEK custom made 3D plates | Experimental | Patients were treated using computer-assisted patient-specific PEEK plates manufactured by CAD/CAM technology and fixed using titanium screws. Receives: Device: Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws. |
| 3D titanium plates on the mandibular angle will be fixed using titanium screws | Active comparator | Patients were treated using conventional 3D titanium plates fixed with titanium screws after reduction of the fracture. Receives: Device: Conventional 3D titanium plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative occlusion stability(binary: yes/no)
Occlusal stability was recorded as stable or unstable. Occlusal stability was assessed clinically by evaluating the intercuspation between maxillary and mandibular teeth. Proper occlusion was defined as normal intercuspation without premature contacts or occlusal discrepancies. Any deviation, including open bite or malocclusion, was recorded during follow-up.
Measured: 1 week, 1 month, and 6 months postoperatively
Secondary outcomes (4)
Condylar seating (binary: yes/no)
Condylar seating was assessed radiographically using standardized panoramic radiographs. The position of the mandibular condyle within the glenoid fossa was evaluated. Proper condylar seating was defined as a normal anatomical position without displacement. Any deviation from the normal position was recorded as improper.
Measured: 1 week, 1 month, and 6 months postoperatively
Postoperative infection (binary: yes/no)
Postoperative infection was recorded as present or absent.
Measured: 1 week, 1 month, and 6 months postoperatively
Wound dehiscence (binary: yes/no)
Wound dehiscence was recorded as present or absent.
Measured: 1 week, 1 month, and 6 months postoperatively
Need for second surgical intervention ( binary: yes/no)
Need for second surgery was recorded as yes or no.
Measured: 1 week, 1 month, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start20 May 2023
- Primary completion30 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fracture MandibleStudies 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
- Model description
- Two groups of patients were assigned in this randomized clinical trial. Group I (Study group): Patients were treated using patient-specific customized 3D PEEK plates for fixation of mandibular angle fractures. Group II (Control group): Patients were treated using conventional 3D titanium plates for fixation of mandibular angle fractures.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Abdelaziz Abdelreheem Abdelhaleem, Cairo University
- Investigators
- Hamida Refaae, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520227
- Sponsor's protocol ID
- 3D-printed (PEEK)
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations.
Publications
Maurice V, Russet F, Scocco P, McNicholas F, Santosh P, Singh SP, Street C, Purper-Ouakil D. Transition from child and adolescent mental health care to adult services for young people with Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD) in Europe: Barriers and recommendations. Encephale. 2022 Oct;48(5):555-559. doi: 10.1016/j.encep.2022.01.012. Epub 2022 Jun 18.
PubMed 35725512Fun WH, Tan EH, Sararaks S, Md Sharif S, Ab Rahim I, Jawahir S, Eow VHY, Sibert RMY, Fadzil MM, Mahmud SH. Implications of Dual Practice on Cataract Surgery Waiting Time and Rescheduling: The Case of Malaysia. Healthcare (Basel). 2021 May 31;9(6):653. doi: 10.3390/healthcare9060653.
PubMed 34072671Amir O, Goldberg Y, Mandel M, Bar-On YM, Bodenheimer O, Ash N, Alroy-Preis S, Huppert A, Milo R. Protection following BNT162b2 booster in adolescents substantially exceeds that of a fresh 2-dose vaccine. Nat Commun. 2022 Apr 13;13(1):1971. doi: 10.1038/s41467-022-29578-w.
PubMed 35418201
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of 3D-printed Polyetheretherketone (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle
- ClinicalTrials.gov ID
- NCT07520227
- Acronym / sponsor ID
- 3D-printed (PEEK)
- Conditions
- Fracture Mandible
- Keywords
- titanium angle fracture mandible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 9 Apr 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.
Is patient specific customized computer assisted 3D PEEK plates more superior to 3D titanium plate in fixation of mandibular angle fractures?
Detailed description
Open Reduction Internal fixation (ORIF) of mandibular angle fractures using titanium plating systems had several drawbacks including sepsis with subsequent wound dehiscence and the need for 2nd surgery which is attributed to bone loss as a result of the elevated modulus of elasticity of titanium hardware. Accordingly, attempts were made to overcome problems encountered with the titanium plating system. In this study, custom made PEEK 3D plates will be used in ORIF of mandibular angle fractures. The main beneficial property of PEEK material is its lower modulus of elasticity that is close to that of living bone with subsequent elimination of the problem of stress shielding phenomenon encountered with titanium plating system. PEEK material has other advantages including biocompatibility, mechanical strength, durability, resistance to high degree of temperature without dimensional alteration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of patients were assigned in this randomized clinical trial. Group I (Study group): Patients were treated using patient-specific customized 3D PEEK plates for fixation of mandibular angle fractures. Group II (Control group): Patients were treated using conventional 3D titanium plates for fixation of mandibular angle fractures.
| Arm | Type | Receives |
|---|---|---|
| Computer-assisted PEEK custom made 3D plates | Experimental | Device: Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws.Patients were treated using computer-assisted patient-specific PEEK plates manufactured by CAD/CAM technology and fixed using titanium screws. |
| 3D titanium plates on the mandibular angle will be fixed using titanium screws | Active comparator | Device: Conventional 3D titanium platesPatients were treated using conventional 3D titanium plates fixed with titanium screws after reduction of the fracture. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with mandibular angle fractures indicated for open reduction and internal fixation (ORIF).
- Patients aged 18 years and above.
- Both male and female patients.
- Patients medically fit for surgery under general anesthesia.
- Patients providing informed consent.
Key exclusion criteria (5 listed)
- Patients with pathological fractures.
- Patients with comminuted fractures not suitable for fixation with plates.
- Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
- Patients with a history of previous mandibular surgery in the same region.
- Patients who are unable or unwilling to comply with follow-up.
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 |
|---|---|---|
| Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws.Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws. | Device | Computer-assisted PEEK custom made 3D plates |
| Conventional 3D titanium platesConventional 3D titanium plates used for fixation of mandibular angle fractures with titanium screws. | Device | 3D titanium plates on the mandibular angle will be fixed using titanium screws |
Primary outcome
Postoperative occlusion stability(binary: yes/no)
Time frame: 1 week, 1 month, and 6 months postoperatively
Occlusal stability was recorded as stable or unstable. Occlusal stability was assessed clinically by evaluating the intercuspation between maxillary and mandibular teeth. Proper occlusion was defined as normal intercuspation without premature contacts or occlusal discrepancies. Any deviation, including open bite or malocclusion, was recorded during follow-up.
4 secondary outcomes
Condylar seating (binary: yes/no)
Time frame: 1 week, 1 month, and 6 months postoperatively
Postoperative infection (binary: yes/no)
Time frame: 1 week, 1 month, and 6 months postoperatively
Wound dehiscence (binary: yes/no)
Time frame: 1 week, 1 month, and 6 months postoperatively
Need for second surgical intervention ( binary: yes/no)
Time frame: 1 week, 1 month, and 6 months postoperatively
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 9 Apr 2026.
- Background: PubMed 35725512Maurice V, Russet F, Scocco P, McNicholas F, Santosh P, Singh SP, Street C, Purper-Ouakil D. Transition from child and adolescent mental health care to adult services for young people with Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD) in Europe: Barriers and recommendations. Encephale. 2022 Oct;48(5):555-559. doi: 10.1016/j.encep.2022.01.012. Epub 2022 Jun 18.
- Background: PubMed 34072671Fun WH, Tan EH, Sararaks S, Md Sharif S, Ab Rahim I, Jawahir S, Eow VHY, Sibert RMY, Fadzil MM, Mahmud SH. Implications of Dual Practice on Cataract Surgery Waiting Time and Rescheduling: The Case of Malaysia. Healthcare (Basel). 2021 May 31;9(6):653. doi: 10.3390/healthcare9060653.
- Background: PubMed 35418201Amir O, Goldberg Y, Mandel M, Bar-On YM, Bodenheimer O, Ash N, Alroy-Preis S, Huppert A, Milo R. Protection following BNT162b2 booster in adolescents substantially exceeds that of a fresh 2-dose vaccine. Nat Commun. 2022 Apr 13;13(1):1971. doi: 10.1038/s41467-022-29578-w.
- Background information on mandibular angle fracture fixation using 3D PEEK and titanium plates.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations.
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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.
Hamida Refaae, PhD study chair
Cairo 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 Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws. and Conventional 3D titanium plates in people with Fracture Mandible, 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 5 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: finished, as of the sponsor's last update on 9 Apr 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?
Postoperative occlusion stability(binary: yes/no) (time frame: 1 week, 1 month, and 6 months postoperatively). 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 NCT07520227, which also lists 3 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 9 Apr 2026.