Clinical Outcome of Dentsply Sirona EV Implants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Implants

Intervention / Treatment
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* Procedure: Dental implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who receive Astra Tech EV dental implant system placement. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Astra Tech EV<br>Patients who has receive Astra Tech dental implant system placement. | Procedure: Dental implant placement<br>* Dental implant placemente on edentulous jaw.<br>* Other names: Implant prosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Success | Dental Implants in function with no complications events | through study completion, a maximum of 5 year | 
| Implant survival | Dental Implants in function with any complications events | through study completion, a maximum of 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological complications | Dental implant treatment with some biological complication | through study completion, a maximum of 5 year | 
| Mechanical complications | Dental implant treatment with some mechanical complication | through study completion, a maximum of 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Implant, Complication, Astra Tech EV