Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534034
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Clinical Outcome of Dentsply Sirona Profile Implants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Outcome of Dentsply Sirona Profile Implants A 12-year Follow-up Retrospective Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a retrospective observational study of 50 implants placed between 2013 and 2023 from the same dental implant system Osseospeed Profile Dentsply Implants Mölndal Sweden
Detailed Description:
The aim of this study is to evaluate the cumulative survival success and complication rates obtained with the use of Osseospeed Profile EV implants in two clinical centres with similar characteristics since its launch on the market in 2013 until today
All clinical records of patients with this implant system will be collected and the following data will be recorded
Patient gender Date of placement Dimensions and location of implants placed Type of implantation Design of the implant-supported dental prosthesis single or partial screw-retained or cemented Date of last radiographic control Type of biological andor mechanical complications that occurred In biological complications presence or absence of inflammatory signs and presence or absence of peri-implant bone loss
For mechanical complications screw loosening porcelain fracture fracture of the prosthetic abutment or fracture of the implant
Date of explantation if present
The mean standard deviation SD and percentage will be calculated for all recorded parameters
A life table will be made with cumulative survival and success rate CSR according to Kaplan-Meier analysis Correlations and regression analysis will be performed to assess the influence of the variables on the outcomes
Conclusions will be drawn based on the results obtained
All clinical records of patients with this implant system will be collected and the following data will be recorded
Patient gender Date of placement Dimensions and location of implants placed Type of implantation Design of the implant-supported dental prosthesis single or partial screw-retained or cemented Date of last radiographic control Type of biological andor mechanical complications that occurred In biological complications presence or absence of inflammatory signs and presence or absence of peri-implant bone loss
For mechanical complications screw loosening porcelain fracture fracture of the prosthetic abutment or fracture of the implant
Date of explantation if present
The mean standard deviation SD and percentage will be calculated for all recorded parameters
A life table will be made with cumulative survival and success rate CSR according to Kaplan-Meier analysis Correlations and regression analysis will be performed to assess the influence of the variables on the outcomes
Conclusions will be drawn based on the results obtained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None