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NCT Number: NCT07515937

Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, Egypt

Location status: Recruiting

Location contact

Arsany Hany Fekry

CONTACT

[email protected]

+2 01030895413

Arsany Hany Fekry

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D-printed occlusal cap splint

Device

Patient specific 3D-printed occlusal cap splint will be used for reduction and fixation of pediatric mandibular fractures

Primary outcomes

  1. 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.

Secondary outcomes

  1. Radiographic evidence of fracture reduction

    Time frame: 3 months

    Radiographic evidence of fracture reduction will be assessed by panoramic radiograph.

  2. Maximum mouth opening

    Time frame: 3 months

    Maximum mouth opening will be assessed in millimeters using a ruler

  3. Post-operative pain

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.