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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| In-Kone® PRIMO | Implant-prosthetic systems made with dental implants and prosthetic components of the ranges In-Kone® PRIMO |
| |
| twinKon® | Implant-prosthetic systems made with dental implants and prosthetic components of the ranges twinKon® |
| |
| EVL® S | Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® S |
| |
| EVL® K | Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® K |
| |
| EVL® C |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental implant surgery with implants | Device | Adult patients who have had dental implant surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | Survival rate at 5 years, 7/8 years and 10 years minimum defined by the rate of implants in situ | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The success rate |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie TRETOUT | Contact | 0478569700 | n.tretout@globald.com |
| Name | Affiliation | Role |
|---|---|---|
| Jean Pierre AXIOTIS, MD | Dental surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental practice | Completed | Andrézieux-Bouthéon | 42160 | France | ||
| Dental practice |
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Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® C |
|
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 |
| 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 |
| 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 |
| 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 |
| Recruiting |
| Athens |
| 15123 |
| Greece |