Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
Study NCT ID:
NCT05647460
Status:
UNKNOWN
Last Update Posted:
2022-12-12
First Post:
2022-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Computer Guided Screw Holes Locating Guide and Custom-made Plates
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Precision of Computer Guided Screw Holes Locating Guide and Custom-made Plates vs Conventional Plate Osteosynthesis in Management of Parasymphseal Mandibular Fracture
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
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:
* Preoperative CT.
* Virtual reduction of broken segments on software.
* Gain occlusion.
* Design surgical screw holes locating guide.
* Design the custom-made plates.
* Print the screw holes locating guide and the custom-made plate. under general anesthesia the parasymphseal fracture will be reduced using screw holes locating guide and the custom-made plates.
* Virtual reduction of broken segments on software.
* Gain occlusion.
* Design surgical screw holes locating guide.
* Design the custom-made plates.
* Print the screw holes locating guide and the custom-made plate. under general anesthesia the parasymphseal fracture will be reduced using screw holes locating guide and the custom-made plates.
Detailed Description:
Interventions 26 patients involved in this study will be divided in to two different groups, first group will be reduced using patient computer guided specific screw holes locating guide and custom-made plates.
Second group fractures will be reduced by conventional work flow.
Clinical evaluation:
A through medical and dental history followed by clinical examination was carried out for all patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion criteria prior to further investigations.
A preoperative digital panoramic radiograph with 1:1 magnification was taken for each patient as a primary survey in order to exclude the presence of any lesion at the area of interest nor segment loss followed by A pre-operative CT.
Virtual planning and guide fabrication for the study group:
* Preoperative CT.
* Virtual reduction of broken segments on software.
* Gain occlusion.
* Design surgical screw holes locating guide.
* Design the custom-made plates.
* Print the screw holes locating guide and the custom-made plate.
* Surgical guiding tools: screw holes locating guide and custom-made plates.
Intra operative procedures for both groups:
• In both group: the operation will under general anesthesia with nasal intubation and oral pack, Injection of 20 cc saline adrenaline 1:00000 to 0 in the sulcus for hemostasis, Vestibular mucosal incision followed by mentalis incision in 2 planes and ensure enough cough for latter muscle suturing, Reflect the flap to visualize the broken segments.
In first group:
Put the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the custom-made plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.
In second group:
mobilize the broken segment first, Arch bar was made to achieve proper occlusion put the compression plate on the inferior border and remove it for further bending using plate pliers for further accommodation of the plate on the inferior border the fix it in place using compression and tension plate.
Second group fractures will be reduced by conventional work flow.
Clinical evaluation:
A through medical and dental history followed by clinical examination was carried out for all patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion criteria prior to further investigations.
A preoperative digital panoramic radiograph with 1:1 magnification was taken for each patient as a primary survey in order to exclude the presence of any lesion at the area of interest nor segment loss followed by A pre-operative CT.
Virtual planning and guide fabrication for the study group:
* Preoperative CT.
* Virtual reduction of broken segments on software.
* Gain occlusion.
* Design surgical screw holes locating guide.
* Design the custom-made plates.
* Print the screw holes locating guide and the custom-made plate.
* Surgical guiding tools: screw holes locating guide and custom-made plates.
Intra operative procedures for both groups:
• In both group: the operation will under general anesthesia with nasal intubation and oral pack, Injection of 20 cc saline adrenaline 1:00000 to 0 in the sulcus for hemostasis, Vestibular mucosal incision followed by mentalis incision in 2 planes and ensure enough cough for latter muscle suturing, Reflect the flap to visualize the broken segments.
In first group:
Put the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the custom-made plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.
In second group:
mobilize the broken segment first, Arch bar was made to achieve proper occlusion put the compression plate on the inferior border and remove it for further bending using plate pliers for further accommodation of the plate on the inferior border the fix it in place using compression and tension plate.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: