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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Mandibular Fracture
• Intervention / Treatment: Device: 3D-printed occlusal cap splint

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt
      • Recruiting
      • Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University
      • Contact: Arsany Hany Fekry; Phone Number: +2 01030895413; Email: arsany.fekry@dentistry.cu.edu.eg
      • Principal Investigator: Arsany Hany Fekry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment by 3D-printed occlusal cap splint	Device: 3D-printed occlusal cap splint; Patient specific 3D-printed occlusal cap splint will be used for reduction and fixation of pediatric mandibular fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occlusion	Occlusion will be assessed to be satisfactory or not, according to Angle classification, absence of midline shift, cross-bite or open-bite.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic evidence of fracture reduction	Radiographic evidence of fracture reduction will be assessed by panoramic radiograph.	3 months
Maximum mouth opening	Maximum mouth opening will be assessed in millimeters using a ruler	3 months
Post-operative pain	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.	1 month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 987654321

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No