Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-01 @ 6:21 PM
Study NCT ID:
NCT04271150
Status:
UNKNOWN
Last Update Posted:
2020-02-17
First Post:
2020-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of Different Modes of Universal Adhesive
Sponsor:
Hacettepe University
Organization:
Study Overview
Official Title:
Clinical Evaluation of Universal Adhesive's Different Application Modes
Status:
UNKNOWN
Status Verified Date:
2020-02
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:
The purpose of this study is to evaluate and compare the clinical performance of a Universal adhesive's different application modes.
Detailed Description:
Class 2 composite restorations will be placed using a bulk-fill composite resin restorative on two posterior teeth with proximal caries, in a split mouth design. 25 patients will be included in the study. The teeth will be randomized into two groups according to the application mode of universal adhesive material.
Group 1: the universal adhesive will be used in etch-and-rinse mode Group 2: the universal adhesive will be used in self-etch mode. The US Public Health Service criteria (secondary caries, anatomical form, surface roughness, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of atraumatic resin restorations. The restorations will be evaluated at baseline and 6th, 12th, 18th, 24th months. Intra-oral photos will be taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.
The data will be analysed statistically using Fisher's Exact Test; and the Kaplan-Meier and Wilcoxon method will be used to estimate survival percentages.
Group 1: the universal adhesive will be used in etch-and-rinse mode Group 2: the universal adhesive will be used in self-etch mode. The US Public Health Service criteria (secondary caries, anatomical form, surface roughness, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of atraumatic resin restorations. The restorations will be evaluated at baseline and 6th, 12th, 18th, 24th months. Intra-oral photos will be taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.
The data will be analysed statistically using Fisher's Exact Test; and the Kaplan-Meier and Wilcoxon method will be used to estimate survival percentages.
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?: