Clinical trial Recruiting at 1 site Interventional Ages 6 to 12

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 typeInterventional
Ages6 Years to 12 Years
SexAll
Enrollment10 (estimated)
SponsorCairo University
Academic / other
Locations1 site (Cairo, Cairo Governorate)
StatusRecruiting
StartedNovember 2026
Main results expectedJuly 2027
Study endsDecember 2027
Registry record updatedOctober 21, 2026
Trial IDNCT07515937 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

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.