Pediatric Mandibular FractureNCT07515937
Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series
A study testing 3D-printed occlusal cap splint in people with Pediatric Mandibular Fracture, run by Cairo University at 1 site in Egypt.
Trial summary
This study is conducted to evaluate the accuracy of 3D-printed acrylic occlusal cap splint fabricated by computer-guided software in reduction and fixation of pediatric mandibular fractures. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pediatric Mandibular Fracture
- What is being tested?
- 3D-printed occlusal cap splint
- 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
- Nov 2026to Dec 2027
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients in the mixed dentition phase, aged from 6 to 12 years, with no gender predilection.
- Recent fracture.
- Single line of fracture; symphyseal, parasymphyseal or body fracture.
Who cannot join
- Patients with systemic diseases that may impair bone repair.
- Patients with more than one line of fracture.
- Patients with pan-facial, ramus, or condylar fractures.
- Patients with comminuted mandibular fractures.
- Patients with infection or pre-existing mandibular pathology at the fracture site.
- Patients who are unable to tolerate follow-up intervals.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate
Arsany Hany Fekry, +2 01030895413, arsany.fekry@dentistry.cu.edu.eg
Arsany Hany Fekry
About this study
This study is conducted to evaluate the accuracy of 3D-printed acrylic occlusal cap splint fabricated by computer-guided software in reduction and fixation of pediatric mandibular fractures. There are a wide range of choices in the management of mandibular pediatric trauma, ranging from observation and follow-up, conservative treatment, and open reduction and internal fixation (ORIF).
Mandibular growth, with the presence of tooth buds, along with deciduous/ permanent teeth eruption (mixed dentition) favor the use of conservative approaches in the management of pediatric mandibular fractures, where splints are fixed over the mandible by the use of circum-mandibular wiring (non-rigid fixation). The virtual surgical planning is increasing in popularity in craniomaxillofacial surgery.
There are multiple advantages that this study offers. First, it is suitable for the patients with a complete primary dentition as well as those in mixed dentition. Second, the fracture segments will be reduced accurately during virtual surgical simulation, improving the accuracy of the operation. Third, due to the splint is done according to the individual dentition of the child, it is more stable than the traditional dental arch splint ligation. Fourth, compared with intraoperative impression taking, pouring them into casts, fracturing and reattaching them in the correct positions to fabricate the splints, it avoids the contamination of the operation area and helps shorten the operation's time spent, and improves the safety and efficiency of the operation.
- Conditions
- Pediatric Mandibular Fracture
- Being tested
- 3D-printed occlusal cap splint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed occlusal cap splintDevice
Patient specific 3D-printed occlusal cap splint will be used for reduction and fixation of pediatric mandibular fractures
| Study group | Role | What they receive |
|---|---|---|
| Treatment by 3D-printed occlusal cap splint | Experimental | Not described Receives: Device: 3D-printed occlusal cap splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion
Occlusion will be assessed to be satisfactory or not, according to Angle classification, absence of midline shift, cross-bite or open-bite.
Measured: 3 months
Secondary outcomes (3)
Radiographic evidence of fracture reduction
Radiographic evidence of fracture reduction will be assessed by panoramic radiograph.
Measured: 3 months
Maximum mouth opening
Maximum mouth opening will be assessed in millimeters using a ruler
Measured: 3 months
Post-operative pain
Post-operative pain will be measured by visual analogue scale (VAS), on a scale from 1 to 10, where 1 is the minimum and 10 is the maximum.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Mandibular FractureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arsany Hany Fekry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515937
- Sponsor's protocol ID
- 987654321
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series
- ClinicalTrials.gov ID
- NCT07515937
- Acronym / sponsor ID
- 987654321
- Conditions
- Pediatric Mandibular Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 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.
This study is conducted to evaluate the accuracy of 3D-printed acrylic occlusal cap splint fabricated by computer-guided software in reduction and fixation of pediatric mandibular fractures. There are a wide range of choices in the management of mandibular pediatric trauma, ranging from observation and follow-up, conservative treatment, and open reduction and internal fixation (ORIF).
Mandibular growth, with the presence of tooth buds, along with deciduous/ permanent teeth eruption (mixed dentition) favor the use of conservative approaches in the management of pediatric mandibular fractures, where splints are fixed over the mandible by the use of circum-mandibular wiring (non-rigid fixation). The virtual surgical planning is increasing in popularity in craniomaxillofacial surgery.
There are multiple advantages that this study offers. First, it is suitable for the patients with a complete primary dentition as well as those in mixed dentition. Second, the fracture segments will be reduced accurately during virtual surgical simulation, improving the accuracy of the operation. Third, due to the splint is done according to the individual dentition of the child, it is more stable than the traditional dental arch splint ligation. Fourth, compared with intraoperative impression taking, pouring them into casts, fracturing and reattaching them in the correct positions to fabricate the splints, it avoids the contamination of the operation area and helps shorten the operation's time spent, and improves the safety and efficiency of the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment by 3D-printed occlusal cap splint | Experimental | Device: 3D-printed occlusal cap splint |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients in the mixed dentition phase, aged from 6 to 12 years, with no gender predilection.
- Recent fracture.
- Single line of fracture; symphyseal, parasymphyseal or body fracture.
Key exclusion criteria (6 listed)
- Patients with systemic diseases that may impair bone repair.
- Patients with more than one line of fracture.
- Patients with pan-facial, ramus, or condylar fractures.
- Patients with comminuted mandibular fractures.
- Patients with infection or pre-existing mandibular pathology at the fracture site.
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-printed occlusal cap splintPatient specific 3D-printed occlusal cap splint will be used for reduction and fixation of pediatric mandibular fractures | Device | Treatment by 3D-printed occlusal cap splint |
Primary outcome
Occlusion
Time frame: 3 months
Occlusion will be assessed to be satisfactory or not, according to Angle classification, absence of midline shift, cross-bite or open-bite.
3 secondary outcomes
Radiographic evidence of fracture reduction
Time frame: 3 months
Maximum mouth opening
Time frame: 3 months
Post-operative pain
Time frame: 1 month
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 21 Oct 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.
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University
Cairo, 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 3D-printed occlusal cap splint in people with Pediatric Mandibular Fracture, 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 3 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: looking for participants now, as of the sponsor's last update on 21 Oct 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusion (time frame: 3 months). 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 21 Oct 2026.