Study Evaluating the Performance and Safety in the Medium Term of Global D Implant-prosthetic Systems

Study Overview
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Brief Summary
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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 term of implant-prosthetic systems including Global D dental implants: In-Kone® UNIVERSAL, In-Kone® PRIMO, 3.0, twinKon® UNIVERSAL, EVL® S, EVL® K and EVL® C.

Detailed Description
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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.

Official Title
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Study Evaluating the Performance and Safety in the Medium Term of Implant-prosthetic Systems Including Ranges of Dental Implants and Prosthetic Components Global D: In-Kone® U,In-Kone® P,3.0,twinKon® U,EVL® S,EVL® K,EVL® C

Conditions
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Dental Implants

Intervention / Treatment
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* Device: Dental implant surgery with implants


Participation Criteria
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Eligibility Criteria
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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® UNIVERSAL implants between July 1, 2014 - June 30, 2015 for 3.0 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 years or any other visit motivated by the removal of the implant during the 5 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In-Kone® UNIVERSAL<br>Implant-prosthetic systems made with dental implants and prosthetic components of the ranges In-Kone® UNIVERSAL | Device: Dental implant surgery with implants<br>* Adult patients who have had dental implant surgery.<br>|
| In-Kone® PRIMO<br>Implant-prosthetic systems made with dental implants and prosthetic components of the ranges In-Kone® PRIMO | Device: Dental implant surgery with implants<br>* Adult patients who have had dental implant surgery.<br>|
| twinKon® UNIVERSAL<br>Implant-prosthetic systems made with dental implants and prosthetic components of the ranges twinKon® UNIVERSAL | Device: Dental implant surgery with implants<br>* Adult patients who have had dental implant surgery.<br>|
| EVL® S<br>Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® S | Device: Dental implant surgery with implants<br>* Adult patients who have had dental implant surgery.<br>|
| EVL® K<br>Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® K | Device: Dental implant surgery with implants<br>* Adult patients who have had dental implant surgery.<br>|
| EVL® C<br>Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® C | Device: Dental implant surgery with implants<br>* Adult patients who have had dental implant surgery.<br>|
| 3.0<br>Implant-prosthetic systems made with dental implants and prosthetic components of the ranges 3.0 | Device: Dental implant surgery with implants<br>* Adult patients who have had dental implant surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Survival rate at 5 years minimum defined by the rate of implants in situ | 5 years | 

Secondary Outcome Measures

| Outcome Measure | 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 and 5 years after surgery | 
| The success rate | The success rate at 5 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 | 
| Appearance of the gum | Appearance of the gum at 5 years. At the 5-year follow-up visit, data 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 | 
| 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 | During the 5 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implant, survival rate, performance