Evaluating the performance and safety of Global D dental implants
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
Global D · NCT04960904
This study is testing how well and safely different Global D dental implants work for patients who got them between 2013 and 2015 by checking in with them over the next 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 514 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Global D (industry) |
| Locations | 2 sites (Andrézieux-Bouthéon and 1 other locations) |
| Trial ID | NCT04960904 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the medium and long-term performance and safety of various Global D dental implant systems. It involves an ambispective multi-center design, collecting data from patients who received these implants between 2013 and 2015. The study will follow up with participants at 5, 7/8, and 10 years post-implantation, gathering both prospective and retrospective data to evaluate outcomes. Twelve centers in France and one in Greece are participating in this comprehensive evaluation.
Who should consider this trial
Good fit: Ideal candidates are adults who received Global D dental implants between 2013 and 2015 and have undergone annual follow-up visits.
Not a fit: Patients who are unable to understand the study information or have passed away after their implantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term reliability and safety of Global D dental implants, potentially improving patient outcomes in dental restoration.
How similar studies have performed: Other studies evaluating the long-term performance of dental implants have shown success, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Andrézieux-Bouthéon and 1 other locations
- Dental practice — Andrézieux-Bouthéon, France (COMPLETED)
- Dental practice — Athens, Greece (RECRUITING)
Study contacts
- Principal investigator: Jean Pierre AXIOTIS, MD — Dental surgeon
- Study coordinator: Nathalie TRETOUT
- Email: n.tretout@globald.com
- Phone: 0478569700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dental Implants, dental implant, survival rate, performance