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Clinical Outcome of Dentsply Sirona EV Implants

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04922489
Enrollment
175
Registered
2021-06-10
Start date
2014-01-01
Completion date
2021-01-01
Last updated
2021-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants

Keywords

Dental Implant, Complication, Astra Tech EV

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.

Interventions

PROCEDUREDental implant placement

Dental implant placemente on edentulous jaw.

Sponsors

Aula Dental Avanzada
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

Inclusion criteria

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

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Implant Successthrough study completion, a maximum of 5 yearDental Implants in function with no complications events
Implant survivalthrough study completion, a maximum of 5 yearDental Implants in function with any complications events

Secondary

MeasureTime frameDescription
Biological complicationsthrough study completion, a maximum of 5 yearDental implant treatment with some biological complication
Mechanical complicationsthrough study completion, a maximum of 5 yearDental implant treatment with some mechanical complication

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026