Clinical Outcome of Dentsply Sirona EV Implants

Completed

• Conditions: Dental Implants

• Registration Number: NCT04922489
• Lead Sponsor: Aula Dental Avanzada

Brief Summary

Retrospective observational study of 500 implants placed between 2014 and 2020 of the same dental implant system (AstraTech Implant System EV, Dentsply Implants, Mölndal, Sweden).

Detailed Description

The purpose of this study is to assess the cumulative survival, success and complications rates obtained with the use of AstraTech Implant System EV in one clinical center from market launch to 2020

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 Timeline

• Study Start: 2014-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-09
• Last Update Submitted: 2021-06-09
• Study First Posted: 2021-06-10
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

All patients who receive Astra Tech EV dental implant system placement.

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant survival	through study completion, a maximum of 5 year	Dental Implants in function with any complications events
Implant Success	through study completion, a maximum of 5 year	Dental Implants in function with no complications events

Secondary Outcome Measures

Name	Time	Method
Biological complications	through study completion, a maximum of 5 year	Dental implant treatment with some biological complication
Mechanical complications	through study completion, a maximum of 5 year	Dental implant treatment with some mechanical complication

Trial Locations

Locations (1)

Clínica Dental Esteve; 🇪🇸 Alicante, Spain