NCT07515937 Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series
| NCT ID | NCT07515937 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cairo University |
| Condition | Pediatric Mandibular Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-07 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-07 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Frequently Asked Questions
Who can join the NCT07515937 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Pediatric Mandibular Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07515937 currently recruiting?
Yes, NCT07515937 is actively recruiting participants. Visit ClinicalTrials.gov or contact Cairo University to inquire about joining.
Where is the NCT07515937 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07515937 clinical trial?
NCT07515937 is sponsored by Cairo University. The trial plans to enroll 10 participants.