Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems
NCT ID: NCT04960904
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
514 participants
OBSERVATIONAL
2019-11-12
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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).
Dental implant surgery with implants
Adult patients who have had dental implant surgery.
In-Kone® PRIMO
Implant-prosthetic systems made with dental implants and prosthetic components of the ranges In-Kone® PRIMO
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®
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
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
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
Dental implant surgery with implants
Adult patients who have had dental implant surgery.
Interventions
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Dental implant surgery with implants
Adult patients who have had dental implant surgery.
Eligibility Criteria
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Inclusion Criteria
* 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
* Deceased patient, date of death after the date of implantation
18 Years
ALL
No
Sponsors
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Global D
INDUSTRY
Responsible Party
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Principal Investigators
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Jean Pierre AXIOTIS, MD
Role: PRINCIPAL_INVESTIGATOR
Dental surgeon
Locations
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Dental practice
Andrézieux-Bouthéon, , France
Dental practice
Athens, , Greece
Countries
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Central Contacts
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Other Identifiers
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1905-G-IMP-DENT-R
Identifier Type: -
Identifier Source: org_study_id
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