Mandibular Angle FracturePhase 4NCT07156812
Custom-Made 3D PEEK for Fixation of Mandibular Angle Fractures.
A Phase 4 study testing Custome made 3D PEEK plate and 3D Titanium plate in people with Mandibular Angle Fracture and Three Dimensional, run by Alexandria University at 1 site in Egypt.
Trial summary
This investigation aimed to determine the clinical and radiographic efficacy of patient-specific, custom-made 3D PEEK plates in comparison with 3D titanium plates for the management of mandibular angle fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Angle Fracture, Three Dimensional, Polyetheretherketone
- What is being tested?
- Custome made 3D PEEK plate and 3D Titanium plate
- 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
- 1 Feb 2022to 1 Dec 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with recent mandibular angle fracture adults without gender predilection who agreed to follow-up, fractures requiring open reduction and internal fixation, medically fit for general anesthesia
Who cannot join
- medically compromised patients, fractures with infection, pathological or old fractures, completely edentulous patients, comminuted fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Custom-Made 3D PEEK Plates Versus 3D Titanium Plates in Mandibular Angle Fracture Fixation: A Randomized Controlled Clinical Trial
This investigation aimed to determine the clinical and radiographic efficacy of patient-specific, custom-made 3D PEEK plates in comparison with 3D titanium plates for the management of mandibular angle fractures.
Read the detailed description
Eighteen patients with recent mandibular angle fractures indicated for open reduction and internal fixation were randomly allocated into two groups. The study group (n = 9) underwent fixation with custom-made 3D PEEK plates, while the control group (n = 9) received prebent 3D titanium plates adapted on virtually reduced models. Follow-up extended to 12 weeks. Clinical parameters included operative time, postoperative occlusion, interfragmentary stability, wound healing, and bite force recovery. Radiographic evaluation was conducted using computed tomography scans acquired immediately postoperatively and at 12 weeks, assessing fracture healing and mean bone density.
- Being tested
- Custome made 3D PEEK plate, 3D Titanium plate
- Keywords
- mandibular angle fracture, PEEK, three-dimensional plate fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custome made 3D PEEK plateDevice
Custome made 3D PEEK plate
3D Titanium plateDevice
Pre-bent 3D Titanium plate
| Study group | Role | What they receive |
|---|---|---|
| patients with recent mandibular angle fractures managed with custome made 3D PEEK plate | Experimental | custome made 3D PEEK plate Receives: Device: Custome made 3D PEEK plate |
| patients with recent mandibular angle fractures managed with 3D Titanium plates | Experimental | 3D Titanium plates Receives: Device: 3D Titanium plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic evaluation for the assessment of mean bone density at the fracture line [Time Frame: 12 weeks]
Mean bone density at the fracture line was assessed using Computed Tomography (CT) scan in Hounsfield Units (HU)
Measured: 12 weeks
Bite force recovery.
bite force recovery measured by a Piezoresistive force transduce sensor: FlexiForce A201 sensor (FlexiForce sensor, by Tekscan Boston, MA, USA. www.tekscan.com)
Measured: 12 weeks
Secondary outcomes (3)
Clinical evaluation for interfragmentary stability.
Intra-fragmentary mobility was evaluated by bimanual palpation at the fracture site
Measured: 12 weeks
clinical evaluation of wound healing
Wound healing is graded according to Southampton wound-grading system
Measured: 14 days
Clinical evaluation of postoperative occlusion
By checking the maximal intercuspal position (centric occlusion) to ensure proper occlusal relationship including molar relation, canine relation and midline centralization
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Feb 2022
- Primary completion1 Jul 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandibular Angle FractureStudies of the same condition, open and under way.
- More trials run by Alexandria 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156812
- Sponsor's protocol ID
- 00010556-12/2021
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
Publications
Kamal AO, Shaaban AM, Shokry MM, Abdelhamed IM. Custom-made 3D PEEK plates versus 3D titanium plates for mandibular angle fracture fixation: a randomized clinical trial. BMC Oral Health. 2026 Jan 30;26(1):384. doi: 10.1186/s12903-025-07646-z.
PubMed 41618317
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Custom-Made 3D PEEK Plates Versus 3D Titanium Plates in Mandibular Angle Fracture Fixation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07156812
- Acronym / sponsor ID
- 00010556-12/2021
- Keywords
- mandibular angle fracture, PEEK, three-dimensional plate fixation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 5 Sep 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.
This investigation aimed to determine the clinical and radiographic efficacy of patient-specific, custom-made 3D PEEK plates in comparison with 3D titanium plates for the management of mandibular angle fractures.
Detailed description
Eighteen patients with recent mandibular angle fractures indicated for open reduction and internal fixation were randomly allocated into two groups. The study group (n = 9) underwent fixation with custom-made 3D PEEK plates, while the control group (n = 9) received prebent 3D titanium plates adapted on virtually reduced models. Follow-up extended to 12 weeks. Clinical parameters included operative time, postoperative occlusion, interfragmentary stability, wound healing, and bite force recovery. Radiographic evaluation was conducted using computed tomography scans acquired immediately postoperatively and at 12 weeks, assessing fracture healing and mean bone density.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| patients with recent mandibular angle fractures managed with custome made 3D PEEK plate | Experimental | Device: Custome made 3D PEEK platecustome made 3D PEEK plate |
| patients with recent mandibular angle fractures managed with 3D Titanium plates | Experimental | Device: 3D Titanium plate3D Titanium plates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with recent mandibular angle fracture adults without gender predilection who agreed to follow-up, fractures requiring open reduction and internal fixation, medically fit for general anesthesia
Key exclusion criteria (1 listed)
- medically compromised patients, fractures with infection, pathological or old fractures, completely edentulous patients, comminuted fractures
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 |
|---|---|---|
| Custome made 3D PEEK plateCustome made 3D PEEK plate | Device | patients with recent mandibular angle fractures managed with custome made 3D PEEK plate |
| 3D Titanium platePre-bent 3D Titanium plate | Device | patients with recent mandibular angle fractures managed with 3D Titanium plates |
Primary outcome
Radiographic evaluation for the assessment of mean bone density at the fracture line [Time Frame: 12 weeks]
Time frame: 12 weeks
Mean bone density at the fracture line was assessed using Computed Tomography (CT) scan in Hounsfield Units (HU)
Bite force recovery.
Time frame: 12 weeks
bite force recovery measured by a Piezoresistive force transduce sensor: FlexiForce A201 sensor (FlexiForce sensor, by Tekscan Boston, MA, USA. www.tekscan.com)
3 secondary outcomes
Clinical evaluation for interfragmentary stability.
Time frame: 12 weeks
clinical evaluation of wound healing
Time frame: 14 days
Clinical evaluation of postoperative occlusion
Time frame: 12 week
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 5 Sep 2025.
- Derived from this study: PubMed 41618317Kamal AO, Shaaban AM, Shokry MM, Abdelhamed IM. Custom-made 3D PEEK plates versus 3D titanium plates for mandibular angle fracture fixation: a randomized clinical trial. BMC Oral Health. 2026 Jan 30;26(1):384. doi: 10.1186/s12903-025-07646-z.
- Individual participant dataSharing planned: Yes. all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
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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 Phase 4 study testing Custome made 3D PEEK plate and 3D Titanium plate in people with Mandibular Angle Fracture and Three Dimensional, run by Alexandria 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 1 inclusion and 1 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 5 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Radiographic evaluation for the assessment of mean bone density at the fracture line [Time Frame: 12 weeks] (time frame: 12 weeks). The study lists 2 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 NCT07156812, which also lists 1 linked publication.
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 5 Sep 2025.