Mandible Fracture, Mandibular Fracture Trauma
Conditions
Keywords
mandibular fractures, anterior transition zone, mental nerve, electrophysiological study
Brief summary
Fractures involving the anterior transition zone of the mandible are frequently encountered and hold particular clinical significance due to the presence of the mental nerve. Consequently, mental nerve paresthesia is among the common postoperative complications associated with these fractures. To assess the mental nerve functional integrity during fixation of fractures at the anterior transition zone using twin fork-miniplate, 3d interlocking miniplate and two miniplates
Detailed description
A total of 36 patients (they were divided into three groups 16 patients in each group ) with parasymphyseal-body fractures , one group was treated with twin-fork miniplate , the second group was treated using 3d interlocking miniplate and the third one was treated with conventional two miniplates. Postoperative evaluation of the mental nerve was conducted using both subjective and objective methods at intervals of 24 hours, and at 1, 4, 6 and 12 weeks. Furthermore, an electrophysiological study was performed at 6 weeks postoperatively to measure the mental nerve's amplitude, onset latency and conduction velocity
Interventions
DEVICETwinfork plate
Twinfork plate
DEVICE3D-interlocking plate
3D-interlocking plate
DEVICEMiniplate
Miniplate
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator
Intervention model description
Patients with with fractures in the anterior transition zone managed with 3 different configurations of miniplates
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients suffering from recent, uninfected and minimally displaced or unfavorable fractures at parasymphysis-body region of the mandible * Adult patients from 20-40 years old with no gender predilection that agreed to present for follow-up visits for a minimum postoperative period of 3 months. * A fracture that demands open reduction and internal fixation. * The patient medically fit for general anesthesia.
Exclusion criteria
* Medically compromised patients contradicting operation. * Pathological fracture. * An old fracture. * Completely edentulous patient. * Patients with frank infection. * Patients with a comminuted fracture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensory nerve function | 6 weeks | Objective assessment by using a dental probe pressure to determine any sensory changes along the distribution of the mental nerve in comparison to the contralateral side (nociceptive method). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic evaluation for fracture healing | 3 months | Preoperative CT scan will be obtained, immediate CT scan will be used to assess the adequacy of fracture line reduction and fixation, and then another CT will be taken at 12th week to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan. |
Countries
Egypt
Outcome results
None listed