Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05711147
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-21
First Post:
2023-01-24
Brief Title:
One-time Abutment Placement Versus 4 Times Abutment Removal Around Dental Implants
Sponsor:
Universidad Complutense de Madrid
Organization:
Universidad Complutense de Madrid
Study Overview
Official Title:
One-time Abutment Placement Versus 4 Times Abutment Removal on Interproximal Bone Levels and Peri-implant Soft Tissues a Prospective Randomized Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
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:
Introduction the repeated connection and disconnection of healing abutments during dental implants osseointegration has been associated with significant increased peri-implant bone loss when compared with placing the final prosthetic abutment during implant placement surgery and non-removing it ever again Previous data from animal studies suggests that the higher the number of removals of the healing abutments the greater the bone resorption around implants however the evidence in humans is scarce and heterogeneous Furthermore this greater bone resorption has been claimed to be associated to the inflammatory status of the peri-implant soft tissues which would be greater as a consequence of the repeated disruption of the soft-tissues attachment to the prosthetic abutment and the hypothetical microbial contamination of the implant-abutment interphase induced by the repeated manipulation of the prosthetic components
Objective to evaluate the changes in peri-implant crestal bone levels between two prosthetic protocols the control being the conventional protocol where healing abutments are placed during surgery and removed four times before the delivery of the final abutment and prostheses and the test protocol where definitive abutments are placed immediately after implant placement and are not removed ever again
Material and methods 80 platform switched implants will be placed in the posterior maxilla or mandible of 40 partial edentulous patients Immediately after implant placement patients will be randomized to receive the definitive abutment at the moment of implant placement one abutment-one time protocol or 12 weeks later after removing the healing abutment four times during the confection of the final prostheses following the conventional protocol for implant supported restorations The day of prostheses delivery a mucosal biopsy from the implant surrounding tissues will be taken for histomorphometric and immunohistochemical analyses of the inflammatory response of the peri-implant soft tissues Radiographic assessment of vertical bone level changes primary outcome clinical status of peri-implant tissues changes in soft tissues margin patient related outcomes and adverse events will be assessed at 6 12 24 and 36 months after loading
Objective to evaluate the changes in peri-implant crestal bone levels between two prosthetic protocols the control being the conventional protocol where healing abutments are placed during surgery and removed four times before the delivery of the final abutment and prostheses and the test protocol where definitive abutments are placed immediately after implant placement and are not removed ever again
Material and methods 80 platform switched implants will be placed in the posterior maxilla or mandible of 40 partial edentulous patients Immediately after implant placement patients will be randomized to receive the definitive abutment at the moment of implant placement one abutment-one time protocol or 12 weeks later after removing the healing abutment four times during the confection of the final prostheses following the conventional protocol for implant supported restorations The day of prostheses delivery a mucosal biopsy from the implant surrounding tissues will be taken for histomorphometric and immunohistochemical analyses of the inflammatory response of the peri-implant soft tissues Radiographic assessment of vertical bone level changes primary outcome clinical status of peri-implant tissues changes in soft tissues margin patient related outcomes and adverse events will be assessed at 6 12 24 and 36 months after loading
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?:
None