Ignite Creation Date:
2024-05-06 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05130996
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2021-11-12
Brief Title:
Observational Study Evaluating Safety and Performance of IDI Dental Implant Systems in Subjects Followed for 18 Months
Sponsor:
Implants Diffusion International
Organization:
Implants Diffusion International
Study Overview
Official Title:
Observational Study Evaluating Safety and Performance of Dental Implant Systems 5 Implant Ranges IDAll IDBio IDCam IDMax ID3 3 Types of Prosthetic Parts Sealed Screw-retained and Removable in Subjects Followed During 18 Month
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Post-Market Clinical Follow-Up to evaluate the safety and performance of IDI dental implant systems confirmation of osseointegration of the different implants at the loading visit between 2 and 6 months after surgery
Detailed Description:
The aim of the present study is to carry out post-marketing clinical monitoring of the medical device used in accordance with the instructions for use according to a medical strategy intended for the person who is suitable for this research which is not fixed in advance by an investigation plan and is part of the current practice of the surgeon
This is a comparative prospective multicenter observational study
The osteointegration reached between 2 and 6 months after surgery will be evaluated by clinical and radiological examinations
This is a comparative prospective multicenter observational study
The osteointegration reached between 2 and 6 months after surgery will be evaluated by clinical and radiological examinations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None