Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems
Recruiting now
Conditions studied: Dental Implants
In brief
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety in the medium and long term of implant-prosthetic systems including Global D dental implants: In-Kone® UNIVERSAL, In-Kone® PRIMO, twinKon®, EVL® S, EVL® K and EVL® C.
Key facts
- Study ID
- NCT04960904
- Run by
- Global D
- People needed
- 514
- Starts
- 2019-11-12
- Expected to finish
- 2026-01-31
- Last updated by the study team
- 2025-04-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female
- Major (s) at the time of the implantation
- Having needed implant surgery with one or more Global D devices:
- between October 1, 2013 - June 30, 2015 for EVL® S, EVL® K and EVL® C, In-Kone® UNIVERSAL and In-Kone® PRIMO implants
- between January 1, 2013 - June 30, 2015 for twinKon® implants
- Affiliated or benefiting from French Social Security
- Not opposing the use of their data
- Having carried out his annual follow-up visit at 5, 7/8 and 10 years or any other visit motivated by the removal of the implant during the 10 years
You may not qualify if…
- Patient unable to understand information related to his/her participation in the study
- Deceased patient, date of death after the date of implantation
Where it is running
- Dental practice — Athens, Greece (enrolling)
- Dental practice — Andrézieux-Bouthéon, France
Full record on ClinicalTrials.gov
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