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Completed

NCT Number: NCT04922489

Clinical Outcome of Dentsply Sirona EV Implants

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).

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Key information

Conditions

Dental Implants

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica Dental Esteve

Alicante, 03001, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Dental implant placement

Procedure

Dental implant placemente on edentulous jaw.

Other names: Implant surgery, Implant prosthesis

Primary outcomes

  1. Implant Success

    Time frame: through study completion, a maximum of 5 year

    Dental Implants in function with no complications events

  2. Implant survival

    Time frame: through study completion, a maximum of 5 year

    Dental Implants in function with any complications events

Secondary outcomes

  1. Biological complications

    Time frame: through study completion, a maximum of 5 year

    Dental implant treatment with some biological complication

  2. Mechanical complications

    Time frame: through study completion, a maximum of 5 year

    Dental implant treatment with some mechanical complication

Sponsors and collaborators

Lead sponsor

Aula Dental Avanzada

Other

Registry information

Official study title

Clinical Outcome of Dentsply Sirona EV Implants: A Retrospective Study of 500 Implants With 6-year Follow-up

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Jun 10, 2021
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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