Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT02293304
Status:
UNKNOWN
Last Update Posted:
2014-11-18
First Post:
2014-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of Universal Adhesive in Primary Molars: a Randomized Clinical Trial
Sponsor:
Universidade Federal de Santa Maria
Organization:
Study Overview
Official Title:
Performance of Universal Adhesive in Primary Molars: a Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
RECRUITING
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 aim of this study is to evaluate the 18-month clinical performance of a multimode adhesive (Scotchbond Universal Adhesive, 3M ESPE, St Paul, MN, USA) in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at two university centers (UFSM and FOUSP). The sample will consist of 132 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal and occlusal-proximal surface. The sample will be randomly divided into two groups according to bonding approach: etch-and-rinse or self-etch strategy. The restorations will be clinically followed every 6 months for up to 18 months using the USPHS modified criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.
Detailed Description:
Randomized clinical trials of performance of universal adhesive in primary molars
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?: