Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-06 @ 8:47 PM
Study NCT ID:
NCT06534034
Status:
COMPLETED
Last Update Posted:
2024-08-05
First Post:
2024-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcome of Dentsply Sirona Profile Implants
Sponsor:
Aula Dental Avanzada
Organization:
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:
False
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 implant(s) 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 and/or 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 implant(s) 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 and/or 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:
False
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?: