Retrospective Evaluation of Clinical Performance of the Astra Tech Implant System EV When Used in Everyday Practice

Dentsply Sirona Implants and Consumables7 sites in 6 countries208 target enrollmentAugust 12, 2019

ConditionsDental Implants

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dental Implants
Sponsor: Dentsply Sirona Implants and Consumables
Enrollment: 208
Locations: 7
Primary Endpoint: Percent of Survived Implants at Time of the Follow-up Visit
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed as a retrospective, multi-center study. The study population consist of subjects who received one or more OsseoSpeed EV implants during the period January 1st 2015 to December 31st 2016. Two hundred subjects will be enrolled, approximately 25-30 subjects per site. The study includes retrospective data collection from subjects' medical records and data collection from one prospective study visit with a clinical examination.

Registry

clinicaltrials.gov

Start Date

August 12, 2019

End Date

December 14, 2020

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Dentsply Sirona Implants and Consumables

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject ≥ 18 years at time of implant installation.
•Subject signed and dated the informed consent form.
•Having installed one or more OsseoSpeed EV implants between January 1st 2015 and December 31st 2016.

Exclusion Criteria

•Unlikely to be able to comply with study procedures, according to Investigator's judgement.
•Subject is not willing to participate in the study or not able to understand the content of the study.
•Involvement in the planning or conduct of the study.
•Simultaneous participation in another clinical study that may interfere with the present study.
•Severe non-compliance to Clinical Investigation Plan (CIP) as judged by the Investigator and/or Dentsply Sirona Implants.

Outcomes

Primary Outcomes

Percent of Survived Implants at Time of the Follow-up Visit

Time Frame: Up to 66 months post-procedure.

Survival defined as implant in situ at time of the follow-up visit. Primary analysis performed on implant level.

Secondary Outcomes

Percent of Successful Implants at Time of the Follow-up Visit(Up to 66 months post-procedure.)
Marginal Bone Levels (MBL)(Up to 66 months post-procedure.)
Soft Tissue Response Measured Through Probing Pocket Depth (PPD) at Time of Follow-up Visit(Up to 66 months post-procedure.)
Percent of Successful Prosthetics at Time of the Follow-up Visit(Up to 66 months post-procedure.)
Soft Tissue Response Measured Through Bleeding on Probing (BoP) at Time of Follow-up Visit(Up to 66 months post-procedure.)
Soft Tissue Response Measured Through Presence of Plaque at Time of Follow-up Visit(Up to 66 months post-procedure.)
Patient Reported Outcome on Implant Level at Time of Follow-up Visit(Up to 66 months post-procedure.)