Mandibular Sub-condylar FractureNCT06978530
3D Custom Plate vs. Standard Titanium Plates for Mandibular Sub-condylar Fractures Fixation
A study testing 3D custom plate and Standard titanium fixation plates in people with Mandibular Sub-condylar Fracture, run by Esraa Mosad Tawfik.
Trial summary
This randomized clinical trial aims to conduct a comprehensive clinical and radiographic evaluation by comparing the efficacy of standard titanium fixation plates with three dimensional custom plate in the management of sub-condylar fractures. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mandibular Sub-condylar Fracture
- What is being tested?
- 3D custom plate and Standard titanium fixation plates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Displaced sub condylar fractures, requiring open reduction and rigid internal fixation
- Age ranges from 18 to 60 years
- Fracture duration less than 2 weeks
- Patients with adequate follow up duration for outcome assessment
Who cannot join
- Comminuted sub condylar fractures
- Patients with severe systemic diseases that may affect fracture healing
- Presence of any pathology at the fracture site
- Patients with previous history of mandibular surgery
- Medically compromised patients who are not fit to undergo surgery under general anesthesia
- Patients with in complete medical records or missing follow up data
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mandibular Sub-condylar Fractures Fixation Using Three-dimensional Custom Plate Versus Standard Titanium Fixation Plates: Randomized Clinical Trial
This randomized clinical trial aims to conduct a comprehensive clinical and radiographic evaluation by comparing the efficacy of standard titanium fixation plates with three dimensional custom plate in the management of sub-condylar fractures. By assessing the clinical outcomes, accuracy of reduction of the fracture segments, and bite force promoted by both fixation modalities.
- Conditions
- Mandibular Sub-condylar Fracture
- Being tested
- 3D custom plate, Standard titanium fixation plates
- Keywords
- Mandibular fracture, 3D custom plate, titanium miniplates, sub-condylar fractures
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D custom plateDevice
Also called patient specific plate
Custom 3D plate will be designed using preoperative CT and virtual surgical planning.
Standard titanium fixation platesDevice
The fixation will be performed according to established surgical principles for managing displaced mandibular sub-condylar fractures without patient-specific planning or customization.
| Study group | Role | What they receive |
|---|---|---|
| 3D Custom Plate group | Experimental | Patients in this group will undergo open reduction and internal fixation of displaced mandibular sub-condylar fractures using preoperatively designed and 3D-printed patient-specific titanium plates. The custom plate is designed based on patient CT data and includes extensions along the posterior border of the mandibular ramus and above the sigmoid notch to facilitate accurate fracture reduction and stable fixation. Receives: Device: 3D custom plate |
| Standard titanium plates group | Active comparator | Patients in this group will undergo open reduction and internal fixation of displaced mandibular sub-condylar fractures using the conventional technique, involving either two standard titanium miniplates or a single 2.3 mm titanium plate. Receives: Device: Standard titanium fixation plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular deviation on opening
Deviation in mm measured using midline reference.
Measured: 1 month, 3 months, and 6 months postoperatively.
Maximum mouth opening
Distance in mm between incisal edges during maximal mouth opening.
Measured: 1 month, 3 months, and 6 months postoperatively.
Secondary outcomes (2)
Bite force
Bite force measured in Newtons at the molar region using a bite force recording device.
Measured: 1 month, 3 months, and 6 months postoperatively
Accuracy of fracture reduction
Evaluated by comparing preoperative CT with postoperative CT using 3D image superimposition analysis
Measured: Immediately postoperative (within 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start10 Apr 2026 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esraa Mosad Tawfik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esraa Mosad Tawfik, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978530
- Sponsor's protocol ID
- 3D-SCF-RCT-2025
- Status last verified
- Mar 2026
- First submitted
- 10 May 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Sub-condylar Fractures Fixation Using Three-dimensional Custom Plate Versus Standard Titanium Fixation Plates: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06978530
- Acronym / sponsor ID
- 3D-SCF-RCT-2025
- Conditions
- Mandibular Sub-condylar Fracture
- Keywords
- Mandibular fracture, 3D custom plate, titanium miniplates, sub-condylar fractures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Esraa Mosad TawfikUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 18 May 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 aims to conduct a comprehensive clinical and radiographic evaluation by comparing the efficacy of standard titanium fixation plates with three dimensional custom plate in the management of sub-condylar fractures. By assessing the clinical outcomes, accuracy of reduction of the fracture segments, and bite force promoted by both fixation modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D Custom Plate group | Experimental | Device: 3D custom platePatients in this group will undergo open reduction and internal fixation of displaced mandibular sub-condylar fractures using preoperatively designed and 3D-printed patient-specific titanium plates. The custom plate is designed based on patient CT data and includes extensions along the posterior border of the mandibular ramus and above the sigmoid notch to facilitate accurate fracture reduction and stable fixation. |
| Standard titanium plates group | Active comparator | Device: Standard titanium fixation platesPatients in this group will undergo open reduction and internal fixation of displaced mandibular sub-condylar fractures using the conventional technique, involving either two standard titanium miniplates or a single 2.3 mm titanium plate. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Displaced sub condylar fractures, requiring open reduction and rigid internal fixation
- Age ranges from 18 to 60 years
- Fracture duration less than 2 weeks
- Patients with adequate follow up duration for outcome assessment
Key exclusion criteria (6 listed)
- Comminuted sub condylar fractures
- Patients with severe systemic diseases that may affect fracture healing
- Presence of any pathology at the fracture site
- Patients with previous history of mandibular surgery
- Medically compromised patients who are not fit to undergo surgery under general anesthesia
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 custom plateAlso: patient specific plateCustom 3D plate will be designed using preoperative CT and virtual surgical planning. | Device | 3D Custom Plate group |
| Standard titanium fixation platesThe fixation will be performed according to established surgical principles for managing displaced mandibular sub-condylar fractures without patient-specific planning or customization. | Device | Standard titanium plates group |
Primary outcome
Mandibular deviation on opening
Time frame: 1 month, 3 months, and 6 months postoperatively.
Deviation in mm measured using midline reference.
Maximum mouth opening
Time frame: 1 month, 3 months, and 6 months postoperatively.
Distance in mm between incisal edges during maximal mouth opening.
2 secondary outcomes
Bite force
Time frame: 1 month, 3 months, and 6 months postoperatively
Accuracy of fracture reduction
Time frame: Immediately postoperative (within 1 week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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.
Questions about this trial
What is this clinical trial studying?
A study testing 3D custom plate and Standard titanium fixation plates in people with Mandibular Sub-condylar Fracture, run by Esraa Mosad Tawfik.
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 4 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: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Mosaad (+201153918930, esraa.tawfik@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mandibular deviation on opening (time frame: 1 month, 3 months, and 6 months postoperatively.). 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?
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 19 Mar 2026.