RecruitingNCT04960904

Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems

Study Evaluating the Performance and Safety in the Medium and Long Term of Implant-prosthetic Systems Including Ranges of Dental Implants and Prosthetic Components Global D: In-Kone® U,In-Kone® P,twinKon®,EVL® S,EVL® K,EVL® C


Sponsor

Global D

Enrollment

514 participants

Start Date

Nov 12, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria2

  • 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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Interventions

DEVICEDental implant surgery with implants

Adult patients who have had dental implant surgery.


Locations(2)

Dental practice

Andrézieux-Bouthéon, France

Dental practice

Athens, Greece

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NCT04960904


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