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

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04960904
• Other study ID #: 1905-G-IMP-DENT-R
• Status: Recruiting
• Start date: November 12, 2019
• Est. completion date: January 31, 2026

Study information

• Verified date: February 2024
• Source: Global D
• Contact: Nathalie TRETOUT
• Phone: 0478569700
• Email: n.tretout[@]globald.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 514
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implants

Intervention

Device:
• Dental implant surgery with implants
Adult patients who have had dental implant surgery.

Locations

Country	Name	City	State
France	Dental practice	Andrézieux-Bouthéon
Greece	Dental practice	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Global D

Countries where clinical trial is conducted

France,  Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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