Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04773873
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2021-02-22
Brief Title:
Implant Retained CAD-CAM Ceramic Crowns
Sponsor:
Susanne Scherrer
Organization:
University of Geneva Switzerland
Study Overview
Official Title:
Randomized Controlled Clinical Trial RCT of Implant-retained Monolithic Chairside-made CAD-CAM Hybrid Abutment Single Crowns
Status:
COMPLETED
Status Verified Date:
2023-12
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:
RCT-Scherrer
Brief Summary:
Newly available ceramic CAD-CAM blocs containing a screw channel for chairside-made crowns to be adhesively cemented to a TiBase abutment and screw-retained to an implant are appealing to the clinician considering the time efficiency one appointment and overall lower costs as no dental laboratory is involved The hypotheses are that the biological BOP PD PCR implant bone level and mechanical outcomes fracture loss of retention wear are equivalent to implant screw-retained Porcelain-Fused-to-Metal PFM crowns over a 5 year observation timeThis RCT will provide key information as to the costbenefit suitability andor limitations of these chair-side hybrid-abutment crowns in the posterior region
Detailed Description:
This RCT involves the University of Geneva Dental School and four private practices for which the Geneva Hospital Ethic Committees approval is required Patients in need for replacement of single unit posterior teeth will be recruited at the Dental School as well as in the 5 private practices based on specific selection criteria Patients will be randomly assigned to a restorative group using a computer-generated random number table for allocation
The CAD-CAM blocs containing a screw channel for implant-retained chairside-made single-unit hybrid-abutment crowns are 1 Lithium-disilicate glass-ceramic emax CAD G1 and 2 feldspath-ceramic infiltrated by polymer Enamic G2 The CAD-CAM crowns are adhesively cemented to titanium base abutments Ti-base and screw-retained to Titanium implants Straumann Standard Plus in the premolar RN and molar region WN Controls are screw-retained PFM crowns G3 The number of crowns in each group is N30 15 molars and 15 premolars which gives a total of 90 crowns for this study
Participants are recalled after 1 week-10 days after crown insertion baseline T0 and then yearly during 5 years T1-T5 Digital X-Rays are taken at T0 T1 T3 and T5 with repositionable individual resin bite registrations
The CAD-CAM blocs containing a screw channel for implant-retained chairside-made single-unit hybrid-abutment crowns are 1 Lithium-disilicate glass-ceramic emax CAD G1 and 2 feldspath-ceramic infiltrated by polymer Enamic G2 The CAD-CAM crowns are adhesively cemented to titanium base abutments Ti-base and screw-retained to Titanium implants Straumann Standard Plus in the premolar RN and molar region WN Controls are screw-retained PFM crowns G3 The number of crowns in each group is N30 15 molars and 15 premolars which gives a total of 90 crowns for this study
Participants are recalled after 1 week-10 days after crown insertion baseline T0 and then yearly during 5 years T1-T5 Digital X-Rays are taken at T0 T1 T3 and T5 with repositionable individual resin bite registrations
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