NCT04960904

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 514 (estimated)
• Sponsor: Global D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Dental Implants

Interventions

Type	Name	Description
DEVICE	Dental implant surgery with implants	Adult patients who have had dental implant surgery.

Timeline

• Start date: 2019-11-12
• Primary completion: 2025-12-31
• Completion: 2026-01-31
• First posted: 2021-07-14
• Last updated: 2025-04-02

Locations

2 sites across 2 countries: France, Greece