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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04960904
Other study ID # 1905-G-IMP-DENT-R
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 12, 2019
Est. completion date January 31, 2026

Study information

Verified date February 2024
Source Global D
Contact Nathalie TRETOUT
Phone 0478569700
Email n.tretout@globald.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Dental implant surgery with implants
Adult patients who have had dental implant surgery.

Locations

Country Name City State
France Dental practice Andrézieux-Bouthéon
Greece Dental practice Athens

Sponsors (1)

Lead Sponsor Collaborator
Global D

Countries where clinical trial is conducted

France,  Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival rate Survival rate at 5 years, 7/8 years and 10 years minimum defined by the rate of implants in situ 5 years
Secondary 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
Secondary The success rate 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
Secondary 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
Secondary 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
Secondary 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
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