Mandibular Fracture
Conditions
Brief summary
Background: Fractures of anterior mandible (symphysis and parasymphysis) make up about 9% to 57%, of mandibular fractures, and body fractures make up about 21%; posing challenges for stabilization due to anatomical constraints. Traditional 3D plates have limitations in this area, leading to the development of Modified 3D Rectangular Grid plates. Studies have shown that these plates offer superior stabilization over larger configurations while maintaining a low profile like miniplates. Additionally, design modifications ensure mental nerve preservation, balancing effective fixation with neurovascular safety. Aim of this study: To evaluate the use of Modified 3D Rectangular Grid plates in comparison with conventional mini plates for fixation of mandibular fracture in the anterior and body regions, clinically regarding pain, interfragmentary mobility, maximal inter-incisal opening, wound healing, and sensory nerve evaluation, and radiographically regrading fracture reduction.
Interventions
OTHERModified 3D Rectangular Grid plate
The system consists of a lower 1.5-mm rectangular plate and an upper linear plate that interlock through circular recesses and elevations. Each component is 0.75 mm thick at the junction, giving a total thickness of 1.5 mm. After screw fixation, it provides 3D stability similar to standard 3D plates while minimizing risk to the mental nerve.
conventional mini plates for fixation of mandibular fracture in the anterior and body regions
Sponsors
Alexandria University
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 symphysis, parasymphysis and body regions * Adult patients with no gender predilection who agreed to present for follow-up visits * A fracture that demands open reduction and internal fixation. * The patient medically fit for general anesthesia
Exclusion criteria
* Patients suffering from recent fractures at the symphysis, parasymphysis and body regions * Adult patients with no gender predilection who agreed to present for follow-up visits * A fracture that demands open reduction and internal fixation * The patient medically fit for general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in maximum mouth opening | up to 6 weeks | Using a millimetre ruler to measure maximal inter-incisal mouth opening; considered to be adequate if \>30 mm and inadequate if \<30 mm |
| change in pain scores | up to 6 weeks | Will be assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in Inter-fragmentary Mobility | up to 6 weeks | The mobility will be assessed by bi-manual palpation across the fracture site. |
| change in Wound Evaluation | up to 6 weeks | The sutured wounds will be examined for signs and symptoms of infection uisng modified Landry's index |
| adequacy of fracture line reduction | 6 weeks | Whenever alignment of the inferior border of the mandible will be maintained across the fracture line, it will be considered an excellent reduction. If a discrepancy of 1-3 mm will be noted, it will be considered a good reduction. If a discrepancy of 3-5 mm will be noted, it will be labeled as a fair reduction. If the discrepancy will be \> 5 mm, it will be considered a poor reduction. |
Countries
Egypt
Outcome results
None listed