Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems
Recruiting
Observational Study
Dental Implants
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
514 (estimated)
Sponsor
Global D · Industry
Who this trial is looking for
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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.
Trial Locations
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City
State
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Status
Eligibility Criteria
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 - Jun…
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
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