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OpenTrials
Completed

NCT Number: NCT06058026

Clinical Comparison of Composite Materials

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Muhammet Karadaş

Rize, Merkez, 53100, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

World Dental Federation criteria (FDI)

Other

Restorations were evaluated with FDI criteria.

Primary outcomes

  1. Evaluation of class II restorative materials restored with different adhesives

    Time frame: Baseline

    Restored teeth were evaluated according to FDI criteria.

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study title

Clinical Evaluation of Composite Resins in Class II Cavities

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 28, 2023
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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