Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT06281002
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trueness of Full Arch Scans and Generated Digital Implant Models
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Assessment of Accuracy of Full Digital Workflow in Fabrication of Four-Implant Screw-Retained Mandibular Hybrid Prostheses
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
The goal of this clinical trial study is to evaluate the accuracy of the full digital workflow for four-implant, screw-retained mandibular hybrid prostheses in patients with completely edentulous mandible.
Detailed Description:
The main issues to evaluate are:
* The trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.
* The trueness of the generated 3D-printed DIMs.
Participants will provide two types of impressions to compare after osteointegration; the first will be conventional open tray impression used as a gold standard comparator, the second will be digital scans with additional geometric scanning aids coupled with the scan bodies.
Accordingly generated 3D-printed DIMs will be printed and compared to the digital image to evaluate its accuracy.
* The trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.
* The trueness of the generated 3D-printed DIMs.
Participants will provide two types of impressions to compare after osteointegration; the first will be conventional open tray impression used as a gold standard comparator, the second will be digital scans with additional geometric scanning aids coupled with the scan bodies.
Accordingly generated 3D-printed DIMs will be printed and compared to the digital image to evaluate its accuracy.
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?: