Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems
ConditionDental Implants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGlobal D
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female
Major (s) at the time of the implantation
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
Disqualifiers
Patient unable to understand information related to his/her participation in the study
Deceased patient, date of death after the date of implantation
Trial 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
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Dental implant surgery with implants
DeviceAdult patients who have had dental implant surgery.
Treatment groups
514 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: In-Kone® UNIVERSAL1 intervention
Group B: In-Kone® PRIMO1 intervention
Group C: twinKon®1 intervention
Group D: EVL® S1 intervention
Group E: EVL® K1 intervention
Group F: EVL® C1 intervention
Trial outcomes
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
Time frame
5 yearsSecondary outcomes
1
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.
Time frame
1-4 month, 6-12 month, 5 years, 7/8 years and 10 years after surgery2
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;
Time frame
5 years, 7/8 years, 10 years3
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
Time frame
5 years, 7/8 years, 10 years4
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
Time frame
Up to 5 years, 7/8 years, and 10 years of follow-up Source ClinicalTrials.gov