3D-printed acrylic occlusal cap splint for fixing broken jaws in children
Official title: Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series
Run by Cairo University · NCT07515937 · Data updated 2026-11-12
We will test whether a computer-planned, 3D-printed acrylic occlusal cap splint can accurately reduce and stabilize single-line mandibular fractures in children aged 6–12 with mixed dentition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 12 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Status | Recruiting |
| Started | November 2026 |
| Main results expected | July 2027 |
| Study ends | December 2027 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07515937 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–12 in the mixed dentition phase with a recent single-line symphyseal, parasymphyseal, or body mandibular fracture who can attend follow-up visits are ideal candidates.
✕Probably not a fit
Children with comminuted fractures, multiple fracture lines, pan‑facial, ramus, or condylar fractures, active infection at the fracture site, or systemic conditions that impair bone healing are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This case series enrolls children aged 6–12 with recent single-line symphyseal, parasymphyseal, or body mandibular fractures in the mixed dentition phase. A custom occlusal cap splint is designed using computer‑guided virtual planning and manufactured by 3D printing, then secured to the mandible using circum‑mandibular wiring as a non‑rigid fixation. The primary focus is on accuracy of fracture reduction and restoration of occlusion, with clinical and radiographic follow-up to document healing. The approach is presented as a conservative alternative to open reduction and internal fixation intended to protect tooth buds and mandibular growth centers.
Why it matters
Potential benefit: If successful, this technique could provide a less invasive way to align and stabilize pediatric jaw fractures while preserving tooth buds and mandibular growth, reducing the need for plate fixation.
How similar studies have gone: Virtual surgical planning and 3D‑printed splints have been reported in adult series and case reports with promising technical results, but robust pediatric evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate, Egypt Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.