Mandibular Angle FractureNCT07231042
Evaluation of Accuracy of Patient-Specific Plate for Reduction and Fixation of Mandibular Angle Fracture
A study testing Patient-Specific Titanium Plate in people with Mandibular Angle Fracture, run by Tanta University at 1 site in Egypt.
Trial summary
This study evaluates the accuracy and clinical effectiveness of patient-specific titanium plates designed using CAD/CAM technology for the reduction and fixation of mandibular angle fractures. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mandibular Angle Fracture
- What is being tested?
- Patient-Specific Titanium Plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Dec 2024to 29 Oct 2025
- 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
- Patient with displaced mandibular angle fracture indicated for open reducation and internal fixation.
- Age of patient > 18 years old .
Who cannot join
- 1- Medically compromised patients with impaired healing ability.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Tanta University
Tanta, Gharbia Governorate, 31527
About this study
Official title: Evaluation of Accuracy of Patient Specific Plate for Reduction and Fixation of Mandibular Angle Fracture
This study evaluates the accuracy and clinical effectiveness of patient-specific titanium plates designed using CAD/CAM technology for the reduction and fixation of mandibular angle fractures. The customized plates are manufactured to match each patient's anatomical morphology, aiming to improve surgical precision, minimize operative time, and enhance postoperative stability. The study assesses clinical outcomes including pain, edema, occlusion, sensory recovery, maximal mouth opening, and radiographic bone healing across multiple follow-up periods. The goal is to determine whether patient-specific plates offer superior clinical and radiographic results compared with conventional fixation methods.
Read the detailed description
This clinical study investigates the use of computer-aided design and computer-aided manufacturing (CAD/CAM) technology to fabricate patient-specific titanium plates for the reduction and fixation of mandibular angle fractures. The customized plates are created based on each patient's CT-derived anatomical morphology, allowing the surgical team to perform virtual planning, simulate fracture reduction, and generate an accurately fitted plate prior to surgery.
The primary objective of the study is to assess the accuracy of anatomical reduction achieved using patient-specific plates and to evaluate short- and medium-term clinical outcomes. All patients are treated using an intraoral surgical approach, with fracture reduction performed according to the preoperative virtual plan. The patient-specific titanium plate is then positioned and fixed without the need for intraoperative plate bending.
Clinical outcomes evaluated in this study include postoperative pain, facial edema, maximal mouth opening, sensory recovery of the inferior alveolar nerve, dental occlusion, and wound healing. Radiographic assessment evaluates bone healing, alignment, intergonial distance, and the accuracy of fracture reduction across multiple follow-up intervals. These evaluations aim to determine the stability and precision of the patient-specific fixation method.
The study follows patients through standardized follow-up periods, including immediate postoperative assessment, 1-week, 1-month, 3-month, and 6-month evaluations. Data are collected prospectively using unified clinical forms and radiological imaging protocols. All procedures adhere to ethical guidelines, and informed consent is obtained from all participants prior to enrollment.
The rationale behind using patient-specific plates is the potential to improve biomechanical stability, reduce operative time, eliminate intraoperative plate bending, and achieve more predictable postoperative outcomes. This study aims to provide evidence on whether CAD/CAM-based customized plates offer measurable advantages over conventional fixation systems in the treatment of mandibular angle fractures.
- Conditions
- Mandibular Angle Fracture
- Being tested
- Patient-Specific Titanium Plate
- Keywords
- CAD/CAM, Patient-Specific Plate, Mandibular Fracture, Angle Fracture, Titanium Plate, Virtual Surgical Planning, Maxillofacial Trauma
- 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 Titanium PlateDevice
A customized titanium fixation plate designed using computer-aided design and manufacturing (CAD/CAM) technology based on preoperative CT data. The plate is fabricated to precisely match the patient's mandibular anatomy and used for open reduction and internal fixation of mandibular angle fractures.
| Study group | Role | What they receive |
|---|---|---|
| Patient-Specific Titanium Plate Fixation | Experimental | All participants will undergo open reduction and internal fixation of displaced mandibular angle fractures using a patient-specific titanium plate fabricated by CAD/CAM technology. The customized plate provides accurate anatomical adaptation, enhanced stability, and reduced operative time. Receives: Device: Patient-Specific Titanium Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Fracture Reduction
Accuracy of anatomical reduction will be evaluated by comparing postoperative CBCT scans with preoperative virtual surgical plans using superimposition analysis to measure the deviation between planned and achieved fragment positions.
Measured: Immediately and 1 week postoperatively
Secondary outcomes (5)
Postoperative Pain Intensity
Pain intensity will be recorded using a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain).
Measured: 1 day, 1 week, and 1 month postoperatively
Postoperative Facial Edema
Facial swelling will be measured using the Souza JA facial edema scale based on standardized anthropometric landmarks.
Measured: 1 week and 2 weeks postoperatively
Occlusal Relationship and Stability
Occlusal stability will be evaluated clinically using the Uglešić occlusion score to assess the degree of alignment and functional contact between opposing teeth
Measured: 1 week, 1 month, and 3 months postoperatively
Recovery of Inferior Alveolar Nerve Function
Sensory recovery of the lower lip and chin will be assessed using light touch and two-point discrimination tests
Measured: 1 week, 1 month, and 3 months postoperatively
Radiographic Bone Healing
Bone union and callus formation will be assessed radiographically on CBCT images to confirm complete healing and stability at the fracture site.
Measured: 3 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 posted17 Nov 2025
- Study start28 Dec 2024
- Primary completion30 Jul 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Angle FractureStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Model description
- A single-arm clinical study evaluating the accuracy, stability, and clinical outcomes of patient-specific titanium plates fabricated using CAD/CAM technology for fixation of mandibular angle fractures.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulaziz Mohsen A Alanazi, Tanta University
- Investigators
- Abdulaziz M Alanazi, Principal investigator, Faculty of Dentistry, Tanta University, EgyptIbrahim M Nowair, Principal investigator, Faculty of Dentistry, Tanta University, EgyptMona S sheta, Principal investigator, Faculty of Dentistry, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231042
- Sponsor's protocol ID
- TANTAOMFS-MAF-160
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy of Patient Specific Plate for Reduction and Fixation of Mandibular Angle Fracture
- ClinicalTrials.gov ID
- NCT07231042
- Acronym / sponsor ID
- TANTAOMFS-MAF-160
- Conditions
- Mandibular Angle Fracture
- Keywords
- CAD/CAM, Patient-Specific Plate, Mandibular Fracture, Angle Fracture, Titanium Plate, Virtual Surgical Planning, Maxillofacial Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Dec 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 17 Nov 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 study evaluates the accuracy and clinical effectiveness of patient-specific titanium plates designed using CAD/CAM technology for the reduction and fixation of mandibular angle fractures. The customized plates are manufactured to match each patient's anatomical morphology, aiming to improve surgical precision, minimize operative time, and enhance postoperative stability. The study assesses clinical outcomes including pain, edema, occlusion, sensory recovery, maximal mouth opening, and radiographic bone healing across multiple follow-up periods. The goal is to determine whether patient-specific plates offer superior clinical and radiographic results compared with conventional fixation methods.
Detailed description
This clinical study investigates the use of computer-aided design and computer-aided manufacturing (CAD/CAM) technology to fabricate patient-specific titanium plates for the reduction and fixation of mandibular angle fractures. The customized plates are created based on each patient's CT-derived anatomical morphology, allowing the surgical team to perform virtual planning, simulate fracture reduction, and generate an accurately fitted plate prior to surgery.
The primary objective of the study is to assess the accuracy of anatomical reduction achieved using patient-specific plates and to evaluate short- and medium-term clinical outcomes. All patients are treated using an intraoral surgical approach, with fracture reduction performed according to the preoperative virtual plan. The patient-specific titanium plate is then positioned and fixed without the need for intraoperative plate bending.
Clinical outcomes evaluated in this study include postoperative pain, facial edema, maximal mouth opening, sensory recovery of the inferior alveolar nerve, dental occlusion, and wound healing. Radiographic assessment evaluates bone healing, alignment, intergonial distance, and the accuracy of fracture reduction across multiple follow-up intervals. These evaluations aim to determine the stability and precision of the patient-specific fixation method.
The study follows patients through standardized follow-up periods, including immediate postoperative assessment, 1-week, 1-month, 3-month, and 6-month evaluations. Data are collected prospectively using unified clinical forms and radiological imaging protocols. All procedures adhere to ethical guidelines, and informed consent is obtained from all participants prior to enrollment.
The rationale behind using patient-specific plates is the potential to improve biomechanical stability, reduce operative time, eliminate intraoperative plate bending, and achieve more predictable postoperative outcomes. This study aims to provide evidence on whether CAD/CAM-based customized plates offer measurable advantages over conventional fixation systems in the treatment of mandibular angle fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm clinical study evaluating the accuracy, stability, and clinical outcomes of patient-specific titanium plates fabricated using CAD/CAM technology for fixation of mandibular angle fractures.
| Arm | Type | Receives |
|---|---|---|
| Patient-Specific Titanium Plate Fixation | Experimental | Device: Patient-Specific Titanium PlateAll participants will undergo open reduction and internal fixation of displaced mandibular angle fractures using a patient-specific titanium plate fabricated by CAD/CAM technology. The customized plate provides accurate anatomical adaptation, enhanced stability, and reduced operative time. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient with displaced mandibular angle fracture indicated for open reducation and internal fixation.
- Age of patient > 18 years old .
Key exclusion criteria (1 listed)
- 1- Medically compromised patients with impaired healing ability.
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 Titanium PlateA customized titanium fixation plate designed using computer-aided design and manufacturing (CAD/CAM) technology based on preoperative CT data. The plate is fabricated to precisely match the patient's mandibular anatomy and used for open reduction and internal fixation of mandibular angle fractures. | Device | Patient-Specific Titanium Plate Fixation |
Primary outcome
Accuracy of Fracture Reduction
Time frame: Immediately and 1 week postoperatively
Accuracy of anatomical reduction will be evaluated by comparing postoperative CBCT scans with preoperative virtual surgical plans using superimposition analysis to measure the deviation between planned and achieved fragment positions.
5 secondary outcomes
Postoperative Pain Intensity
Time frame: 1 day, 1 week, and 1 month postoperatively
Postoperative Facial Edema
Time frame: 1 week and 2 weeks postoperatively
Occlusal Relationship and Stability
Time frame: 1 week, 1 month, and 3 months postoperatively
Recovery of Inferior Alveolar Nerve Function
Time frame: 1 week, 1 month, and 3 months postoperatively
Radiographic Bone Healing
Time frame: 3 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 17 Nov 2025.
- Individual participant dataSharing planned: No
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Safety-zone Approach and Facial Nerve Preservation in Transbuccal-accessed Fixation of Mandibular 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.
Abdulaziz M Alanazi principal investigator
Faculty of Dentistry, Tanta University, Egypt
Ibrahim M Nowair principal investigator
Faculty of Dentistry, Tanta University, Egypt
Mona S sheta principal investigator
Faculty of Dentistry, Tanta University, Egypt
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 Titanium Plate in people with Mandibular Angle Fracture, run by Tanta 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 2 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 17 Nov 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.
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?
Accuracy of Fracture Reduction (time frame: Immediately and 1 week postoperatively). 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 17 Nov 2025.