The Impact of ESWT on Healing of Fractured Mandible

Cairo University (CU)

Status: Enrolling

Conditions: Fractured Mandible Due to Trauma

Treatments: Device: Radial Extracorporeal shockwave

Study type: Observational

Funder types: Other

Identifiers

NCT06363188

effect of ESWT on fractures

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

10 participants in 2 patient groups

intervention group

Description:

Firstly the patient is generally anesthetized by the anesthesiologist. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used. The transoral or extraoral 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 1 plate2.0 (champy) Then suturing the incision layers Postoperative evaluation with cone beam computed tomography (CBCT). These procedures will be done for both groups. This 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.

Treatment:

Device: Radial Extracorporeal shockwave

control group

Description:

Firstly the patient is generally anesthetized by the anesthesiologist. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used. The transoral or extraoral 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 1 plate2.0 (champy) Then suturing the incision layers Postoperative evaluation with cone beam computed tomography (CBCT). The control group with no adjuvant intervention will stop at this point. Then follow up at the first and fourth month with another CBCT to compare the bone healing at the fracture site.