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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implants
• Intervention / Treatment: Device: Dental implant surgery with implants

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.

• Study Type: Observational
• Enrollment (Estimated): 514

Contacts and Locations

• Study Contact: Name: Nathalie TRETOUT; Phone Number: 0478569700; Email: n.tretout@globald.com

Study Locations

• France
  • Andrézieux-Bouthéon, France, 42160
    • Completed
    • Dental practice
• Greece
  • Athens, Greece, 15123
    • Recruiting
    • Dental practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Adult patients who have had dental implant surgery.
EVL® S; Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® S	Device: Dental implant surgery with implants; Adult patients who have had dental implant surgery.
EVL® K; Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® K	Device: Dental implant surgery with implants; Adult patients who have had dental implant surgery.
EVL® C; Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® C	Device: Dental implant surgery with implants; Adult patients who have had dental implant surgery.
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; Adult patients who have had dental implant surgery.
twinKon®; Implant-prosthetic systems made with dental implants and prosthetic components of the ranges twinKon®	Device: Dental implant surgery with implants; Adult patients who have had dental implant surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant system stability	Implant system stability of all follow-up visits. Stability of the implant system is assessed by the investigator at each visit. The variable collected is YES for stable implant and NO for unstable implant.	1-4 month, 6-12 month, 5 years, 7/8 years and 10 years after surgery
The success rate	The success rate at 5 years, 7/8 years and 10 years defined by the rate of stable implants without pain or sensitivity at the implant level, with the absence of peri-implantitis and osteolysis;	5 years, 7/8 years, 10 years
Appearance of the gum	Appearance of the gum based on the visual appearance of the gum will be collected. Several choices are possible: Inflammation / Gingival recession / Absence of keratinized tissue band around the crown	5 years, 7/8 years, 10 years
Adverse events and complications	Nature, number, severity and degree of relationship of adverse events, serious or not, reported as implant-related or unrelated for non-serious adverse events, immediate or delayed at all visits	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)	The score obtained from the satisfaction and quality of life questionnaire (OHIP-14) at 5 years The Oral Health Impact Profile 14 (OHIP-14) [14] is a questionnaire measuring the impact of the prosthetic restoration on the patient's well-being and quality of life. The patient answers fourteen questions grouped into seven domains (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap) . For each question, the patient can answer with one of the following values: never:0, almost never:1, occasionally:2, quite often:3, very often:4. The sum of the values for each question gives a score that can vary from 0 to 56. A high score reflects a high level of discomfort.	5 years, 7/8 years, 10 years

Collaborators and Investigators

• Sponsor: Global D
• Investigators: Principal Investigator: Jean Pierre AXIOTIS, MD, Dental surgeon

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: performance; dental implant; survival rate
• Other Study ID Numbers: 1905-G-IMP-DENT-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No