Actively Recruiting

Phase Not Applicable
Age: 6Years - 12Years
All Genders
NCT07515937

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

Led by Cairo University · Updated on 2026-04-07

10

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric patients aged 6 to 12 years in the mixed dentition phase
  • Recent mandibular fracture
  • Single line fracture in symphyseal, parasymphyseal, or body region of the mandible
  • No gender restriction
Not Eligible

You will not qualify if you...

  • Presence of systemic diseases impairing bone repair
  • More than one fracture line
  • Pan-facial, ramus, or condylar fractures
  • Comminuted mandibular fractures
  • Infection or pre-existing pathology at the fracture site
  • Inability to tolerate follow-up visits

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Cairo, Cairo Governorate, Egypt

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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