Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate, Egypt
Location status: Recruiting
NCT Number: NCT07515937
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.
Interested in participating?
Request Info6 year–12 year
All sexes
Interventional
Not applicable
Cairo, Cairo Governorate, Egypt
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient specific 3D-printed occlusal cap splint will be used for reduction and fixation of pediatric mandibular fractures
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.
Time frame: 3 months
Radiographic evidence of fracture reduction will be assessed by panoramic radiograph.
Time frame: 3 months
Maximum mouth opening will be assessed in millimeters using a ruler
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.
Cairo University
Other
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