Fractured Mandible Due to Trauma
Conditions
Brief summary
studying if using extracorporeal radial shockwave therapy as an adjuvant therapy help in accelerating the bone healing and regeneration in mandibular fractures by comparing it with the standard protocol for fractures fixation by plates and screws.
Detailed description
Firstly the patient heads to the operating room being placed in a supine position, generally anesthetized by the anesthesiologist. Sterilization of intraoral and extraoral sites and draping has been installed. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used. If the arch bar has been used it was inserted before the operation and being cut at the fracture line between the two segments. The transoral or extra-oral approach is utilized to expose the fracture line separating the two segments. Fixation of the bony segments with two plates one Compression 2.3 plate at the inferior border and Tension 2.0 plate five millimeter superiorly to the compression plate. or even one 2.0 plate(champy) Then suturing the incision layers with vicryl 3/0. Postoperative evaluation with cone beam computed tomography (CBCT). These procedures will be done for both groups. The control group with no adjuvant intervention will stop at this point. The other intervention group will be subjected to shockwave by the usage of extracorporeal shockwave device at the third day postoperative. Then follow up at the first and fourth month with another CBCT to compare the bone healing at the fracture site.
Interventions
a device used by physiotherapist to treat various musculoskeletal problems and it was here firstly used to accelerate the bone healing process after bone fracture
Sponsors
Cairo University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
1 - Patients with age ranges from 18-75 years old. 2- Patients with fresh mandibular fractures (from zero hour till four or five days). 3- Patients free of systemic conditions that might affect or interfere with the healing process of bone segments or rather interfere with carrying out the surgical procedure (thyroid condition, rheumatoid arthritis, uncontrolled diabetes and osteoporosis).
Exclusion criteria
1 - Patients out of the specified range group 2- Patients who went previous operations with infection or malunion. 3- Patients with thyroid condition which affects the serum calcium level. 4- Patients with systemic conditions that might affect the bone health (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes). 5- Patients with heart peacemakers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone healing (denisty of bone) | first and fourth month | radiographically we will analyze the bone denisty at the fracture site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain sensation | immediately after the intervention and 3 days after | depending on the patient using VAS |
Countries
Egypt
Contacts
Primary Contactkhloud nasr el-din, GP.
Backup ContactEmad Saied, prof.
Outcome results
None listed