Mandibular Sub-condylar FractureSUBCONDPLATENCT07231055
Comparative Trial of Custom-Made Titanium Plates Versus 3D Lambda Plates for Mandibular Subcondylar Fractures
A study testing Custom-Made Plate Group and Three-Dimensional Lambda Plate in people with Mandibular Sub-condylar Fracture, run by Tanta University at 1 site in Egypt.
Trial summary
This randomized clinical trial compares virtually designed custom-made titanium plates with conventional three-dimensional (3D) lambda plates for the fixation of mandibular subcondylar fractures. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Mandibular Sub-condylar Fracture
- What is being tested?
- Custom-Made Plate Group and Three-Dimensional Lambda Plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult Patients with mandibular subcondylar fracture indicated for open reduction and internal fixation.
Who cannot join
- Patients with systemic diseases that affect tissue healing.
- Mandibular condylar head or neck fractures. (Condylar neck is the where the caudal portion of the joint capsule attaches. It is the thin constricted area immediately below the condylar head.)
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: Virtually Designed Custom-Made Titanium Plate Versus Three-Dimensional Lambda Plate for Management of Mandibular Subcondylar Fractures: (A Randomized Controlled Trial)
This randomized clinical trial compares virtually designed custom-made titanium plates with conventional three-dimensional (3D) lambda plates for the fixation of mandibular subcondylar fractures. A total of 24 fracture sites will be treated using a retromandibular trans-masseteric approach and evaluated through virtual surgical planning, radiographic analysis, and functional outcomes. The study aims to determine whether customized plates provide superior anatomical accuracy, stability, and recovery compared with standard 3D plates.
Read the detailed description
Mandibular subcondylar fractures can affect occlusion, mandibular function, and facial symmetry, and remain a topic of ongoing clinical debate regarding optimal fixation methods. Conventional management often relies on standardized three-dimensional (3D) plates, such as the lambda configuration, which provides reliable fixation but may not precisely conform to the individual patient's anatomy.
Advances in virtual surgical planning (VSP) and computer-aided design now allow for the fabrication of patient-specific titanium plates that follow the exact contours of each patient's mandibular anatomy. These customized implants may improve reduction accuracy, minimize inter-fragmentary gaps, enhance postoperative stability, and reduce intraoperative manipulation.
In this study, 24 subcondylar fracture sites will be randomly assigned to either a patient-specific custom-made plate group or a conventional 3D lambda plate group. All procedures will be performed using the retromandibular trans-masseteric approach. Preoperative planning will include CT-based segmentation, virtual fracture reduction, and 3D model generation. Postoperative follow-up will be conducted at multiple intervals to assess radiographic bone healing, condylar and gonial width symmetry, inter-fragmentary gap, mandibular function, pain scores, occlusion, edema, and soft tissue healing.
The study seeks to evaluate whether the use of a customized fixation system results in measurable improvements in surgical precision and functional recovery compared with standard 3D plating techniques. Findings from this clinical trial may support evidence-based decision-making in the selection of fixation systems for subcondylar fractures and clarify the potential clinical benefits of patient-specific implant technology.
- Conditions
- Mandibular Sub-condylar Fracture
- Being tested
- Custom-Made Plate Group, Three-Dimensional Lambda Plate
- Keywords
- Mandibular sub-condylar fractures, Fractures of mandible, condylar fractures of mandible, Patient specific plate, CAD/CAM, Virtual Surgical planning, Randomized Controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-Made Plate GroupDevice
Virtually designed Patient-specific titanium plate fabricated using virtual surgical planning, CT-based segmentation, and 3D design for fixation of mandibular subcondylar fractures.
Three-Dimensional Lambda PlateDevice
Standard ready-made three-dimensional titanium lambda plate used for open reduction and internal fixation of mandibular subcondylar fractures.
| Study group | Role | What they receive |
|---|---|---|
| Custom-Made plate Group | Experimental | Patient-specific titanium plate fabricated using virtual surgical planning, CT-based segmentation, and 3D design for fixation of mandibular subcondylar fractures. Receives: Device: Custom-Made Plate Group |
| Three-Dimensional (3D) Lambda plate Group | Active comparator | Standard ready-made three-dimensional titanium lambda plate used for open reduction and internal fixation of mandibular subcondylar fractures. Receives: Device: Three-Dimensional Lambda Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
The total operative time required to perform open reduction and internal fixation of mandibular subcondylar fractures, measured from incision to completion of fixation. The outcome will be compared between the custom-made titanium plate group and the 3D lambda plate group.
Measured: Intraoperative (recorded during the surgical procedure)
Secondary outcomes (4)
Pain Scor (VAS)
Visual Analog Scale score to assess postoperative pain intensity over time.
Measured: Immediate postoperative, 1 week, 2 weeks, 1 month, 3 months, 6 months.
Occlusal Function (Uglesic Score)
Evaluation of occlusal stability and masticatory function using the Uglesic et al. (1993) occlusion questionnaire.
Measured: 1 week, 1 month, 3 months, 6 months.
Mouth Opening (Maximum Inter-Incisal Distance, mm)
Measurement of maximal mouth opening to evaluate functional recovery.
Measured: Preoperative, 1 week, 2 weeks, 1 month, 3 months, 6 months.
Radiographic Bone Healing (Computed Tomography Evaluation)
Computed Tomography based evaluation of bone union, accuracy of reduction and consolidation at the fracture site.
Measured: 1 month, 3 months, 6 months.
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 Sub-condylar FractureStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ahmed Thamer Al Masoud, Tanta University
- Investigators
- Mohammed A Almasoud, Principal investigator, Faculty of Dentistry, Tanta University, EgyptMohamed M Khedr, Principal investigator, Faculty of Dentistry, Tanta University, EgyptAhmed A Mosleh, Principal investigator, Faculty of Dentistry, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231055
- Sponsor's protocol ID
- TU-OMFS-2025-SUBCONDYLAR-CT
- Acronym
- SUBCONDPLATE
- 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
- Virtually Designed Custom-Made Titanium Plate Versus Three-Dimensional Lambda Plate for Management of Mandibular Subcondylar Fractures: (A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT07231055
- Acronym / sponsor ID
- SUBCONDPLATE / TU-OMFS-2025-SUBCONDYLAR-CT
- Conditions
- Mandibular Sub-condylar Fracture
- Keywords
- Mandibular sub-condylar fractures, Fractures of mandible, condylar fractures of mandible, Patient specific plate, CAD/CAM, Virtual Surgical planning, Randomized Controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 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 randomized clinical trial compares virtually designed custom-made titanium plates with conventional three-dimensional (3D) lambda plates for the fixation of mandibular subcondylar fractures. A total of 24 fracture sites will be treated using a retromandibular trans-masseteric approach and evaluated through virtual surgical planning, radiographic analysis, and functional outcomes. The study aims to determine whether customized plates provide superior anatomical accuracy, stability, and recovery compared with standard 3D plates.
Detailed description
Mandibular subcondylar fractures can affect occlusion, mandibular function, and facial symmetry, and remain a topic of ongoing clinical debate regarding optimal fixation methods. Conventional management often relies on standardized three-dimensional (3D) plates, such as the lambda configuration, which provides reliable fixation but may not precisely conform to the individual patient's anatomy.
Advances in virtual surgical planning (VSP) and computer-aided design now allow for the fabrication of patient-specific titanium plates that follow the exact contours of each patient's mandibular anatomy. These customized implants may improve reduction accuracy, minimize inter-fragmentary gaps, enhance postoperative stability, and reduce intraoperative manipulation.
In this study, 24 subcondylar fracture sites will be randomly assigned to either a patient-specific custom-made plate group or a conventional 3D lambda plate group. All procedures will be performed using the retromandibular trans-masseteric approach. Preoperative planning will include CT-based segmentation, virtual fracture reduction, and 3D model generation. Postoperative follow-up will be conducted at multiple intervals to assess radiographic bone healing, condylar and gonial width symmetry, inter-fragmentary gap, mandibular function, pain scores, occlusion, edema, and soft tissue healing.
The study seeks to evaluate whether the use of a customized fixation system results in measurable improvements in surgical precision and functional recovery compared with standard 3D plating techniques. Findings from this clinical trial may support evidence-based decision-making in the selection of fixation systems for subcondylar fractures and clarify the potential clinical benefits of patient-specific implant technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom-Made plate Group | Experimental | Device: Custom-Made Plate GroupPatient-specific titanium plate fabricated using virtual surgical planning, CT-based segmentation, and 3D design for fixation of mandibular subcondylar fractures. |
| Three-Dimensional (3D) Lambda plate Group | Active comparator | Device: Three-Dimensional Lambda PlateStandard ready-made three-dimensional titanium lambda plate used for open reduction and internal fixation of mandibular subcondylar fractures. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult Patients with mandibular subcondylar fracture indicated for open reduction and internal fixation.
Key exclusion criteria (2 listed)
- Patients with systemic diseases that affect tissue healing.
- Mandibular condylar head or neck fractures. (Condylar neck is the where the caudal portion of the joint capsule attaches. It is the thin constricted area immediately below the condylar head.)
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 Plate GroupVirtually designed Patient-specific titanium plate fabricated using virtual surgical planning, CT-based segmentation, and 3D design for fixation of mandibular subcondylar fractures. | Device | Custom-Made plate Group |
| Three-Dimensional Lambda PlateStandard ready-made three-dimensional titanium lambda plate used for open reduction and internal fixation of mandibular subcondylar fractures. | Device | Three-Dimensional (3D) Lambda plate Group |
Primary outcome
Operative time
Time frame: Intraoperative (recorded during the surgical procedure)
The total operative time required to perform open reduction and internal fixation of mandibular subcondylar fractures, measured from incision to completion of fixation. The outcome will be compared between the custom-made titanium plate group and the 3D lambda plate group.
4 secondary outcomes
Pain Scor (VAS)
Time frame: Immediate postoperative, 1 week, 2 weeks, 1 month, 3 months, 6 months.
Occlusal Function (Uglesic Score)
Time frame: 1 week, 1 month, 3 months, 6 months.
Mouth Opening (Maximum Inter-Incisal Distance, mm)
Time frame: Preoperative, 1 week, 2 weeks, 1 month, 3 months, 6 months.
Radiographic Bone Healing (Computed Tomography Evaluation)
Time frame: 1 month, 3 months, 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 17 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Mandibular Sub-condylar Fracture
Not yet recruiting
3D Custom Plate vs. Standard Titanium Plates for Mandibular Sub-condylar Fractures Fixation
Mandibular Sub-condylar Fracture
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.
Mohammed A Almasoud principal investigator
Faculty of Dentistry, Tanta University, Egypt
Mohamed M Khedr principal investigator
Faculty of Dentistry, Tanta University, Egypt
Ahmed A Mosleh 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 Custom-Made Plate Group and Three-Dimensional Lambda Plate in people with Mandibular Sub-condylar 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 1 inclusion and 2 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?
Operative time (time frame: Intraoperative (recorded during the surgical procedure)). 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.