Dental Implants
Conditions
Keywords
dental implant, survival rate, performance
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.
Interventions
DEVICEDental implant surgery with implants
Adult patients who have had dental implant surgery.
Sponsors
Global D
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
France, Greece
Contacts
Primary ContactNathalie TRETOUT
Outcome results
None listed