NCT05130996

Observational Study Evaluating Safety and Performance of IDI Dental Implant Systems in Subjects Followed for 18 Months.

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 121 (estimated)
• Sponsor: Implants Diffusion International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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:

Conditions

• Dental Prosthesis

Interventions

Type	Name	Description
DEVICE	dental prothesis	5 ranges of implants can be used : IDAll, IDBio, IDCam, IDMax, ID3

Timeline

• Start date: 2022-05-09
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2021-11-23
• Last updated: 2024-03-06

Locations

1 site across 1 country: France