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Clinical Comparison of Composite Materials

Clinical Evaluation of Composite Resins in Class II Cavities

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06058026
Enrollment
150
Registered
2023-09-28
Start date
2020-12-31
Completion date
2022-09-17
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries; Dentin

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).

Interventions

Restorations were evaluated with FDI criteria.

Sponsors

Recep Tayyip Erdogan University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of class II restorative materials restored with different adhesivesBaselineRestored teeth were evaluated according to FDI criteria.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026