Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 6:50 PM
Study NCT ID:
NCT02889835
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations
Sponsor:
Solventum US LLC
Organization:
Study Overview
Official Title:
"Clinical Performance of an Incrementally Placed Highly Filled Composite, an Incrementally Placed Flowable Composite, and a Bulk Filled Composite in Class II Restorations"
Status:
COMPLETED
Status Verified Date:
2024-09
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:
This study will examine the clinical performance of Class II restorations over a three year period with 3 composite resins - a conventional composite resin, a flowable composite resin and a bulk placed and cured composite resin.
Detailed Description:
Specific Aim: To place three commercially available resin composites in Class II cavity preparations of adult patients, evaluate the resin composite restorations at baseline, 6 months, 1 year, 2 and 3 years using specific criteria defined by International Dental Federation (FDI).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: