Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363188
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-09
Brief Title:
The Impact of ESWT on Healing of Fractured Mandible
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
The Impact of Using Extracorporeal Radial Shock Wave Therapy as an Adjuvant Therapy vs Conventional Open Reduction and Internal Fixation With No Adjuvant Therapy on Bone Healing for Patients With Mandibular Parasymphyseal Body and Angle Fractures
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 23 plate at the inferior border and Tension 20 plate five millimeter superiorly to the compression plate
or even one 20 platechampy Then suturing the incision layers with vicryl 30 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
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 23 plate at the inferior border and Tension 20 plate five millimeter superiorly to the compression plate
or even one 20 platechampy Then suturing the incision layers with vicryl 30 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None