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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-12

Study Completion Date

2020-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Dental Implants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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OsseoSpeed EV implant

The investigational product (OsseoSpeed EV implant) is already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No