NCT04960904 Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems
| NCT ID | NCT04960904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Global D |
| Condition | Dental Implants |
| Study Type | OBSERVATIONAL |
| Enrollment | 514 participants |
| Start Date | 2019-11-12 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 514 participants in total. It began in 2019-11-12 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jean Pierre AXIOTIS, MD
PRINCIPAL INVESTIGATOR
Dental surgeon
Frequently Asked Questions
Who can join the NCT04960904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dental Implants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04960904 currently recruiting?
Yes, NCT04960904 is actively recruiting participants. Contact the research team at n.tretout@globald.com for enrollment information.
Where is the NCT04960904 trial being conducted?
This trial is being conducted at Andrézieux-Bouthéon, France, Athens, Greece.
Who is sponsoring the NCT04960904 clinical trial?
NCT04960904 is sponsored by Global D. The principal investigator is Jean Pierre AXIOTIS, MD at Dental surgeon. The trial plans to enroll 514 participants.