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

NCT04960904 | Recruiting DMC

• 1 other identifier: 1905-G-IMP-DENT-R
• Study Type: observational
• Target: 514
• Locations: 2 countries
• Sites: 2

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.

Conditions

Dental Implants

Keywords

dental implant; survival rate; performance

Outcome Measures

Primary Outcomes (1)

• Survival rate

  Survival rate at 5 years, 7/8 years and 10 years minimum defined by the rate of implants in situ

  5 years

Secondary Outcomes (5)

• Implant system stability

  1-4 month, 6-12 month, 5 years, 7/8 years and 10 years after surgery

• The success rate

  5 years, 7/8 years, 10 years

• Appearance of the gum

  5 years, 7/8 years, 10 years

• Adverse events and complications

  Up to 5 years, 7/8 years, and 10 years of follow-up

• Score of Quality of life (OHIP-14 - The Oral Health Impact Profile)

  5 years, 7/8 years, 10 years

Study Arms (6)

In-Kone® UNIVERSAL

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).

Device: Dental implant surgery with implants

In-Kone® PRIMO

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

Device: Dental implant surgery with implants

twinKon®

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

Device: Dental implant surgery with implants

EVL® S

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

Device: Dental implant surgery with implants

EVL® K

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

Device: Dental implant surgery with implants

EVL® C

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

Device: Dental implant surgery with implants

Interventions

Dental implant surgery with implants DEVICE

Adult patients who have had dental implant surgery.

EVL® C; EVL® K; EVL® S; In-Kone® PRIMO; In-Kone® UNIVERSAL; twinKon®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male or female patients who have had dental implant surgery. In the perspective of being able to obtain follow-up data at least 5 years and up to 10 years and the series to be continuous and exhaustive, the implantation period will be limited from * October 1, 2013 to June 30, 2015 for EVL® S, EVL® K and EVL® C, In-Kone® UNIVERSAL and In-Kone® PRIMO implants * January 1, 2013 to June 30, 2015 for twinKon® implants

You may qualify if:

• 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

You may not qualify if:

• Patient unable to understand information related to his/her participation in the study
• Deceased patient, date of death after the date of implantation

Sponsors & Collaborators

• Global D: lead

Study Sites (2)

Dental practice

Andrézieux-Bouthéon, 42160, France

COMPLETED

Dental practice

Athens, 15123, Greece

RECRUITING

Study Officials

• Jean Pierre AXIOTIS, MD

  Dental surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie TRETOUT

CONTACT

0478569700; n.tretout@globald.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 14, 2021
• Study Start: November 12, 2019
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); FR (1)