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NCT Number: NCT04960904

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

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.

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Key information

Conditions

Dental Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dental practice, Andrézieux-Bouthéon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental implant surgery with implants

Device

Adult patients who have had dental implant surgery.

Primary outcomes

  1. Survival rate

    Time frame: 5 years

    Survival rate at 5 years, 7/8 years and 10 years minimum defined by the rate of implants in situ

Secondary outcomes

  1. Implant system stability

    Time frame: 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.

  2. The success rate

    Time frame: 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;

  3. Appearance of the gum

    Time frame: 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

  4. Adverse events and complications

    Time frame: 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

  5. Score of Quality of life (OHIP-14 - The Oral Health Impact Profile)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nathalie TRETOUT

CONTACT

[email protected]

0478569700

Sponsors and collaborators

Lead sponsor

Global D

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Jul 14, 2021
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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