Pediatric Mandibular Fracture
Conditions
Brief summary
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
DEVICE3D-printed occlusal cap splint
Patient specific 3D-printed occlusal cap splint will be used for reduction and fixation of pediatric mandibular fractures
Sponsors
Cairo University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occlusion | 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
| Measure | Time frame | Description |
|---|---|---|
| Radiographic evidence of fracture reduction | 3 months | Radiographic evidence of fracture reduction will be assessed by panoramic radiograph. |
| Maximum mouth opening | 3 months | Maximum mouth opening will be assessed in millimeters using a ruler |
| Post-operative pain | 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. |
Countries
Egypt
Outcome results
None listed