Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D-printed occlusal cap splint.
- Who it may be relevant to
- Registry conditions: Pediatric Mandibular Fracture. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 3D-printed occlusal cap splint
Patient specific 3D-printed occlusal cap splint will be used for reduction and fixation of pediatric mandibular fractures
Primary outcome measures
- Occlusion [Time frame: 3 months]
Secondary outcome measures (3)
- Radiographic evidence of fracture reduction [Time frame: 3 months]
- Maximum mouth opening [Time frame: 3 months]
- Post-operative pain [Time frame: 1 month]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University — Cairo
Identifiers
NCT: NCT07515937 · 987654321