NCT06058026

Clinical Comparison of Composite Materials

Clinical Evaluation of Composite Resins in Class II Cavities

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Recep Tayyip Erdogan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Caries; Dentin

Interventions

Type	Name	Description
OTHER	World Dental Federation criteria (FDI)	Restorations were evaluated with FDI criteria.

Timeline

• Start date: 2020-12-31
• Primary completion: 2021-09-15
• Completion: 2022-09-17
• First posted: 2023-09-28
• Last updated: 2024-04-23

Locations

1 site across 1 country: Turkey (Türkiye)