Mandibular Fractures
Conditions
Brief summary
Mandibular fractures are a common type of facial fractures. The surgical treatment has developed over the years due to improved understanding of biomechanics, biomaterials and scientifically based treatment outcomes. since customized fixation mechanism is more suited to the bone surface which helps to meet the requirements of a semirigid fixation. Customized Z plate is a new geometry of miniplates that may provide superior preservation of mental nerve, stability, support and easier in adaptation compared to the standard 2 miniplates system for fixation of parasymhyseal/body mandibular fractures.
Interventions
OTHERcustomized Z shaped miniplate
Planning was done using Mimics Innovation Suite 15.0 software for surgical planning, surgical simulation, and modeling of a custom-made Z-pattern plate installed on a standard personal computer system. The milling of a plate design on a titanium block was be done.
OTHERconventional two miniplates
Mobilization of the fracture, removal of any soft tissue entrapped within the fracture line, and management of teeth in the fracture line, either by extraction or preservation. Followed by bone reduction into proper anatomical occlusion. Then conventional two miniplates was used according to Champy's osteosynthesis lines
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients suffering from recent fractures at the parasymphysis/body of the mandible presented within 2 weeks of the date of trauma. * Radiographic evidence of parasymphyseal/body mandibular fracture that demands open reduction and internal fixation. * The patient is medically fit for general anesthesia
Exclusion criteria
* comminuted fracture. * Pathological fracture. * Presence of infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain scores | after 24-hours, one week, four weeks and six weeks | Patient asked to identify his pain sensation through a 10-point visual analogue scale (VAS) and the level of pain will be interpreted as (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe). |
| Presence of intra-fragmentary mobility | up to 6 weeks | The mobility assessed by bi-manual palpation across the fracture site. |
| Change in bone density | baseline and 6 months | Immediate CBCT scan will be used to assess the adequacy of fracture line reduction and fixation, and then another will be taken at 6th month to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sensory nerve function | after 24-hours, one week, four weeks and six weeks | Presecne of alteration in sensation in lower lip and mental area (Yes/No) |
Countries
Egypt
Outcome results
None listed