Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-09 @ 8:05 PM
Study NCT ID:
NCT03086720
Status:
UNKNOWN
Last Update Posted:
2017-03-22
First Post:
2017-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deproteinization as a Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions
Sponsor:
Federal University of Pelotas
Organization:
Study Overview
Official Title:
Effect of Sodium Hypochlorite Pre-treatment on the Retention of Restorations for Non-carious Cervical Lesions: A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
ACTIVE_NOT_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:
This study will verify the effect of the application of a substance (10% sodium hypoclorite -NaOCL) in dentin on noncarious cervical lesions, with the aim of increasing the longevity of the restorations performed in this type of lesion.
The hypothesis of the present study is that the application of deproteinization solution after acid etching does not influence the failure rate of the restorations.
The hypothesis of the present study is that the application of deproteinization solution after acid etching does not influence the failure rate of the restorations.
Detailed Description:
The purpose of this study will be to evaluate the failure rates of composite restorations of non-carious cervical lesions (NCCL) performed with or without the pre-treatment with 10% sodium hypochlorite (NaOCl) on etched dentin.
A randomized controlled split-mouth and double blind clinical trial will be carried out. Patients with at least two NCCL will be selected. Each patient will be received at least one pair of composite restorations (Filtek Z350/3M ESPE), bonded either with 2 techniques: control (acid etching + placebo solution for 60 seconds + Adper Single Bond 2/3M ESPE) or experimental (acid etching + 10% NaOCl for 60 seconds + Adper Single Bond 2). A calibrated examiner will be evaluated the restorations (baseline, 6-, 12-, 24- and 36-month) using the FDI criteria. The primary outcome is retention of the restoration.
A randomized controlled split-mouth and double blind clinical trial will be carried out. Patients with at least two NCCL will be selected. Each patient will be received at least one pair of composite restorations (Filtek Z350/3M ESPE), bonded either with 2 techniques: control (acid etching + placebo solution for 60 seconds + Adper Single Bond 2/3M ESPE) or experimental (acid etching + 10% NaOCl for 60 seconds + Adper Single Bond 2). A calibrated examiner will be evaluated the restorations (baseline, 6-, 12-, 24- and 36-month) using the FDI criteria. The primary outcome is retention of the restoration.
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?:
None
Is an FDA AA801 Violation?: