Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05748327
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2023-02-09
Brief Title:
Trial With Two New Tooth-colored Restorative Materials in Class III Cavities
Sponsor:
Ivoclar Vivadent AG
Organization:
Ivoclar Vivadent AG
Study Overview
Official Title:
Randomized Controlled Clinical Trial RCT of the New Tooth-colored Restorative Material Cention Forte Ivoclar Vivadent vs Equia Forte HT GC in Class-III Cavities
Status:
ACTIVE_NOT_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:
This is a randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores 1 2 and 3
Detailed Description:
The primary outcome of the study is the SUCCESS RATE of restorations placed with both filling materials in class I and II cavities after 5 years of clinical service A failure which leads to repair or replacement of the restoration can have esthetic marginal staining loss of anatomical form functional ie fracture of restoration loss of retention or biological reasons ie secondary caries A restoration is defined as a failure no success as soon as at least one FDI criterion is scored as 4 or 5
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S66086 | OTHER | KU Leuven | None |