Clinical Comparison of Composite Materials

Clinical Evaluation of Composite Resins in Class II Cavities

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 primer/adhesive 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.

Study Overview

• Status: Completed
• Conditions: Caries; Dentin
• Intervention / Treatment: Other: World Dental Federation criteria (FDI)

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 Fisher's Exact test. The effect of time on restorations was evaluated using the Friedman test (p < 0.05).

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Rize, Merkez, Turkey, 53100
      • Muhammet Karadaş

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Teeth with primary caries, including at least one-third of the dentin (MO or DO), were included in the study.

Description

Inclusion Criteria:

• Individuals without systemic disease
• Individuals with good oral hygiene
• Must be a minimum of one carious defect
• Must be at least 18 years old
• Must have vital teeth in antagonist and proximal contact.

Exclusion Criteria:

• Pregnant or breastfeeding women
• Receiving orthodontic treatment
• Bruxism habit
• Direct or indirect pulp coverage
• Allergy to resin-based products

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of class II restorative materials restored with different adhesives	Restored teeth were evaluated according to FDI criteria.	Baseline

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University
• Investigators: Principal Investigator: Muhammet Karadaş, PhD, Recep Tayyip Erdogan University

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2020
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): September 17, 2022

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RTEUDHFMKARADAS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No