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

Global D

Status: Enrolling

Conditions: Dental Implants

Treatments: Device: Dental implant surgery with implants

Study type: Observational

Funder types: Industry

Identifiers

NCT04960904

1905-G-IMP-DENT-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 514 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

514 participants in 6 patient groups

In-Kone® UNIVERSAL

Description:

Implant-prosthetic systems made with dental implants and prosthetic components of the ranges In-Kone® UNIVERSAL, including the former 3.0 range now named In-Kone® Universal NR (narrow), and including the In-Kone® Universal WD (wide).

Treatment:

Device: Dental implant surgery with implants

In-Kone® PRIMO

Description:

Implant-prosthetic systems made with dental implants and prosthetic components of the ranges In-Kone® PRIMO

Treatment:

Device: Dental implant surgery with implants

twinKon®

Description:

Implant-prosthetic systems made with dental implants and prosthetic components of the ranges twinKon®

Treatment:

Device: Dental implant surgery with implants

EVL® S

Description:

Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® S

Treatment:

Device: Dental implant surgery with implants

EVL® K

Description:

Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® K

Treatment:

Device: Dental implant surgery with implants

EVL® C

Description:

Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® C

Treatment:

Device: Dental implant surgery with implants