3D-printed acrylic occlusal cap splint for fixing broken jaws in children
Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07515937 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cairo, Cairo Governorate
- Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University — Cairo, Cairo Governorate, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.