Clinical trial NCT04960904: Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dental Implants
Keywords: dental implant
survival rate
performance
Lead sponsor: Global D
Sponsor class: INDUSTRY
First posted: 2021-07-14
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival rate
timeFrame: 5 years
Secondary outcomes:
measure: Implant system stability
timeFrame: 1-4 month, 6-12 month, 5 years, 7/8 years and 10 years after surgery
measure: The success rate
timeFrame: 5 years, 7/8 years, 10 years
measure: Appearance of the gum
timeFrame: 5 years, 7/8 years, 10 years
measure: Adverse events and complications
timeFrame: Up to 5 years, 7/8 years, and 10 years of follow-up
measure: Score of Quality of life (OHIP-14 - The Oral Health Impact Profile)
timeFrame: 5 years, 7/8 years, 10 years
Other outcomes:
Locations:
city: Andrézieux-Bouthéon
country: France
facility: Dental practice
city: Athens
country: Greece
facility: Dental practice
Study officials:
affiliation: Dental surgeon
name: Jean Pierre AXIOTIS, MD
role: PRINCIPAL_INVESTIGATOR
References: