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

Last updated: March 27, 2025
Sponsor: Global D
Overall Status: Active - Recruiting

Phase

N/A

Condition

Medical Prosthetics

Treatment

Dental implant surgery with implants

Clinical Study ID

NCT04960904
1905-G-IMP-DENT-R
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 othervisit motivated by the removal of the implant during the 10 years

Exclusion

Exclusion Criteria:

  • Patient unable to understand information related to his/her participation in thestudy

  • Deceased patient, date of death after the date of implantation

Study Design

Total Participants: 514
Treatment Group(s): 1
Primary Treatment: Dental implant surgery with implants
Phase:
Study Start date:
November 12, 2019
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Dental practice

    Andrézieux-Bouthéon, 42160
    France

    Completed

  • Dental practice

    Athens, 15123
    Greece

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.