Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT06392204
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Assessment of Mandibular CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique (A Randomized Controlled Trial)
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:
This proposed study aims at creating a computer designed patient specific device and titanium plates, that are 3D manufactured in accordance to a preoperative computer aided virtual surgical procedure, aiming to obtain proper alignment of fractured segments of the lower jaw and restore proper teeth positioning therefore overcoming the possible complications of the conventional methods.
Recruited participants will be randomly allocated to a treatment groupp, whether the novel method group or a standard treatment group.
Preoperative panoramic radiograph and a Computed tomography scan will be obtained for each patient.
Surgical procedure will be conducted unde general anesthetic. Medications will be prescribed after surgery and instructions will be given to each patient.
Follow up will be on a weekly basis for the first 6 weeks followed by a followup visit once a month for 6 months.
Postoperative panoramic radiograph and a Computed tomography scan will be obtained at 1 week after the surgical procrdure and again 6 months later.
Digital data obtained from computed tomography scans along with clinical data will be analysed and studied to determine the accuracy of the computer aided device and for comparison with the standard method of treatment.
Recruited participants will be randomly allocated to a treatment groupp, whether the novel method group or a standard treatment group.
Preoperative panoramic radiograph and a Computed tomography scan will be obtained for each patient.
Surgical procedure will be conducted unde general anesthetic. Medications will be prescribed after surgery and instructions will be given to each patient.
Follow up will be on a weekly basis for the first 6 weeks followed by a followup visit once a month for 6 months.
Postoperative panoramic radiograph and a Computed tomography scan will be obtained at 1 week after the surgical procrdure and again 6 months later.
Digital data obtained from computed tomography scans along with clinical data will be analysed and studied to determine the accuracy of the computer aided device and for comparison with the standard method of treatment.
Detailed Description:
None
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?: