Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-04 @ 11:11 PM
Study NCT ID:
NCT03221660
Status:
COMPLETED
Last Update Posted:
2025-04-13
First Post:
2017-07-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy
Sponsor:
Ivoclar Vivadent AG
Organization:
Study Overview
Official Title:
Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy
Status:
COMPLETED
Status Verified Date:
2025-03
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:
The objective of this study is to evaluate the clinical performance of F-Composite 2 system in Class I and Class II cavities in permanent teeth.
The materials of the system can be polymerized in short time with a curing light which is part of the system.
The study will be carried out as a prospective study, with evaluation of the restorations after 7-10 days (baseline), at 6 months, at 12 months, at 24 months and 60 months according to defined criteria.
The materials of the system can be polymerized in short time with a curing light which is part of the system.
The study will be carried out as a prospective study, with evaluation of the restorations after 7-10 days (baseline), at 6 months, at 12 months, at 24 months and 60 months according to defined criteria.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: