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Clinical Trials/NCT06058026
NCT06058026
Completed
Not Applicable

Clinical Evaluation of Composite Resins in Class II Cavities

Recep Tayyip Erdogan University1 site in 1 country150 target enrollmentDecember 31, 2020
ConditionsCaries; Dentin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caries; Dentin
Sponsor
Recep Tayyip Erdogan University
Enrollment
150
Locations
1
Primary Endpoint
Evaluation of class II restorative materials restored with different adhesives
Status
Completed
Last Updated
2 years ago

Overview

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 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.

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).

Registry
clinicaltrials.gov
Start Date
December 31, 2020
End Date
September 17, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Recep Tayyip Erdogan University
Responsible Party
Principal Investigator
Principal Investigator

Muhammet Karadaş

Assistan Professor

Recep Tayyip Erdogan University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Evaluation of class II restorative materials restored with different adhesives

Time Frame: Baseline

Restored teeth were evaluated according to FDI criteria.

Study Sites (1)

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