Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06017596
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2023-08-05
Brief Title:
CAD-CAM PEEK Framework for All-on-4 Implants
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Evaluation of Polyetheretherketone PEEK Framework Inserted in Multiunit Abutments of All-on-4 Concept for the Mandibular Edentulous Arch
Status:
COMPLETED
Status Verified Date:
2023-07
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 study was conducted to evaluate the clinical peri-implant soft tissue changes during the first year after occlusal loading and the ridge base relation after 3 years for mandibular computer-aided design and computer-aided manufacturing CADCAM screw-retained implant-supported hybrid prosthesis of polyetheretherketone PEEK framework utilized with All-on-Four treatment concept
Detailed Description:
Sixteen completely edentulous patients were rehabilitated by four implants following the All-on-Four protocol After 3 months the definitive prosthesis was constructed to be a screw-retained CAD-CAM milled framework from the modified PEEK BioHPP bonded to polymethylmethacrylate teeth and a pink-shaded indirect light-polymerized nano-filled composite resin imitating the soft tissues Peri-implant soft tissue changes regarding plaque bleeding gingival scores and probing depth were evaluated at prosthesis insertion T0 6 months T1 and 12 months T2 after insertion Also monitoring of the ridge base relation was performed using cone-beam computed tomography CBCT at the time of insertion T0 and 1 year T1 2 years T2 and 3 years T3 after mandibular fixed detachable All-on-Four framework insertion
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?:
None