Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407271
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-12
Brief Title:
Effect of Abutment Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial
Sponsor:
Semmelweis University
Organization:
Semmelweis University
Study Overview
Official Title:
Effect of Abutment 3-dimensional Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial
Status:
RECRUITING
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:
None
Brief Summary:
The aims of our study are to investigate in patients with immediate implantation replacing a single tooth in the maxillary anterior FDI 15-25 region the effect of a custom vs cylindrical stock healing abutments then b screw retained single ceramic crowns on the peri implant hard- and soft-tissue formation and blood flow
Detailed Description:
AIMS
In the maxilla in the aesthetic zone in patients with a thick phenotype for a crown anchored with a solo immediate implant
IA To investigate hard and soft tissue volume changes around custom CADCAM computer-aided design and manufacturing vs cylindrical zirconiom-dioxide ZrO2 healing abutments 4 months after their fixation for immediate implant placement
IB To measure the thickness of keratinized mucosa by ultrasound IC Monitoring microcirculation in wound healing by laser speckle contrast imaging LSCI and ultrasound
II Custom zirconia abutment on Ti-base retained screw-retained all-ceramic solo restorations
Evaluation of hard and soft tissue volume changes
Esthetic evaluation Pink and White Aesthetic Scores PES WES FIPS functional implant prosthodontic score pain follow-up of biological and technical complications at 1 and 3 years
ARMS
A immediate implantation cylindrical healing abutment CADCAM screw-retained on Ti-base full-countour monolithic zirconium-dioxide restoration
B immediate implantation custom healing abutment CADCAM screw-retained on Ti-base custom ZrO2 abutment retained all-ceramic restoration with hand-built-up supramucosal veneering
In the maxilla in the aesthetic zone in patients with a thick phenotype for a crown anchored with a solo immediate implant
IA To investigate hard and soft tissue volume changes around custom CADCAM computer-aided design and manufacturing vs cylindrical zirconiom-dioxide ZrO2 healing abutments 4 months after their fixation for immediate implant placement
IB To measure the thickness of keratinized mucosa by ultrasound IC Monitoring microcirculation in wound healing by laser speckle contrast imaging LSCI and ultrasound
II Custom zirconia abutment on Ti-base retained screw-retained all-ceramic solo restorations
Evaluation of hard and soft tissue volume changes
Esthetic evaluation Pink and White Aesthetic Scores PES WES FIPS functional implant prosthodontic score pain follow-up of biological and technical complications at 1 and 3 years
ARMS
A immediate implantation cylindrical healing abutment CADCAM screw-retained on Ti-base full-countour monolithic zirconium-dioxide restoration
B immediate implantation custom healing abutment CADCAM screw-retained on Ti-base custom ZrO2 abutment retained all-ceramic restoration with hand-built-up supramucosal veneering
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