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

Dentsply

Status: Completed

Conditions: Dental Implants

Treatments: Device: OsseoSpeed EV implant

Study type: Observational

Funder types: Industry

Identifiers

NCT03845738

C-AS-18-001

Details and patient eligibility

About

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.

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design