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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Dental implant surgery with implants
  Adult patients who have had dental implant surgery.

Первичные конечные точки

• Survival rate [Срок оценки: 5 years]

Вторичные конечные точки (5)

• Implant system stability [Срок оценки: 1-4 month, 6-12 month, 5 years, 7/8 years and 10 years after surgery]
• The success rate [Срок оценки: 5 years, 7/8 years, 10 years]
• Appearance of the gum [Срок оценки: 5 years, 7/8 years, 10 years]
• Adverse events and complications [Срок оценки: 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) [Срок оценки: 5 years, 7/8 years, 10 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Patient unable to understand information related to his/her participation in the study
• Deceased patient, date of death after the date of implantation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Dental practice — Andrézieux-Bouthéon

Греция · 1 центр

• Dental practice — Athens

Идентификаторы

NCT: NCT04960904 · 1905-G-IMP-DENT-R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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