Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems
- Conditions
- Dental Implants
- Interventions
- Device: Dental implant surgery with implants
- Registration Number
- NCT04960904
- Lead Sponsor
- Global D
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 514
- 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
- Patient unable to understand information related to his/her participation in the study
- Deceased patient, date of death after the date of implantation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description In-Kone® UNIVERSAL Dental implant surgery with implants 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). EVL® S Dental implant surgery with implants Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® S EVL® K Dental implant surgery with implants Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® K In-Kone® PRIMO Dental implant surgery with implants Implant-prosthetic systems made with dental implants and prosthetic components of the ranges In-Kone® PRIMO EVL® C Dental implant surgery with implants Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® C twinKon® Dental implant surgery with implants Implant-prosthetic systems made with dental implants and prosthetic components of the ranges twinKon®
- Primary Outcome Measures
Name Time Method Survival rate 5 years Survival rate at 5 years, 7/8 years and 10 years minimum defined by the rate of implants in situ
- Secondary Outcome Measures
Name Time Method Adverse events and complications Up to 5 years, 7/8 years, and 10 years of follow-up 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
Score of Quality of life (OHIP-14 - The Oral Health Impact Profile) 5 years, 7/8 years, 10 years 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.
Implant system stability 1-4 month, 6-12 month, 5 years, 7/8 years and 10 years after surgery 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.
The success rate 5 years, 7/8 years, 10 years 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;
Appearance of the gum 5 years, 7/8 years, 10 years 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
Trial Locations
- Locations (1)
Dental practice
🇬🇷Athens, Greece