Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT04685967
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2020-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin
Sponsor:
Hacettepe University
Organization:
Study Overview
Official Title:
Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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 clinical performance of a restorative glass ionomer and bulk-fill resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a restorative glass ionomer \[Equia Forte HT, GC, Tokyo, Japan (EHT)\] and bulk-fill composite resin \[SonicFill2, Orange, CA, USA (SBF)\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.
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?:
None
Is an FDA AA801 Violation?: