Viewing Study NCT06058026



Ignite Creation Date: 2024-05-06 @ 7:33 PM
Last Modification Date: 2024-10-26 @ 3:09 PM
Study NCT ID: NCT06058026
Status: COMPLETED
Last Update Posted: 2024-04-23
First Post: 2023-09-21

Brief Title: Clinical Comparison of Composite Materials
Sponsor: Recep Tayyip Erdogan University
Organization: Recep Tayyip Erdogan University

Study Overview

Official Title: Clinical Evaluation of Composite Resins in Class II Cavities
Status: COMPLETED
Status Verified Date: 2024-02
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: Universal adhesive solutions have just entered the market allowing dentists to choose an adhesive strategy based on the needs of patients and clinical situations Theses adhesives contain a primeradhesive resin mix in a single bottle for multi-mode etch-and-rinse or self-etch applications The aim of this study was to evaluate the clinical performance of composite resins with diffent adesive agents on Class II cavities
Detailed Description: This study was a double-blind evaluator and patient randomized controlled clinical study with six study groups with an equal allocation Two composite materials with two universal and one two-step self-etch adhesives were compared in Class II restorations

The treated patients were called back for controls after one week six months and eighteen months Restorations were evaluated clinically according to modified FDI criteria In terms of esthetic property marginal discoloration in terms of function properties fracture and retention and marginal adaptation in terms of the biological characteristics post-operative sensitivity and secondary caries criteria were examined

Clinical evaluation was performed by two qualified clinicians Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 18-month to evaluate the formation of secondary caries

Differences between adhesives at each time period were evaluated using Fishers Exact test The effect of time on restorations was evaluated using the Friedman test p 005

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?: None