Overview
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.
Description
Study design: Ambispective multi-center observational study, on a single patient group per implant, constituting a consecutive and exhaustive series of subjects, without selection.
Investigators:Twelve centers participated to the study in France and one in Greece.
The objectives are evaluate the 5-year follow-up performance and safety of Global D dental implant ranges, which consist of collecting data at a 5-year follow-up visit (prospectively or retrospectively). All previous data is collected retrospectively from the patient's file. The study has been extended to 7/8 years and up to 10 years follow-up.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient unable to understand information related to his/her participation in the study
- Deceased patient, date of death after the date of implantation