Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
NCT07547904

Clinical Performance of Bioactive Bulk-Fill in Class II Restorations

Led by Bezmialem Vakif University · Updated on 2026-04-23

34

Participants Needed

1

Research Sites

81 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This prospective split-mouth clinical study aims to compare the clinical performance of a bioactive bulk-fill composite with a conventional microhybrid composite in Class II posterior restorations. In each participant, two comparable Class II cavities will be treated using different restorative approaches. In the experimental condition, a bioactive bulk-fill composite (Activa BioACTIVE Bulk Flow) will be placed at the gingival base and covered with a microhybrid composite (Filtek Z250). In the control condition, restorations will be completed entirely with the microhybrid composite (Filtek Z250). Clinical performance will be evaluated according to FDI World Dental Federation criteria at baseline, 6 months, and 12 months. Primary outcomes include marginal adaptation, retention, and overall clinical success of the restorations. Secondary outcomes include surface properties and marginal staining. The split-mouth design allows direct intra-individual comparison, thereby minimizing inter-individual variability and increasing the reliability of the findings. The results of this study are expected to provide evidence on the effectiveness of bioactive bulk-fill composites in improving the clinical performance of posterior restorations.

CONDITIONS

Official Title

Clinical Performance of Bioactive Bulk-Fill in Class II Restorations

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged between 18 and 50 years
  • Patients requiring at least two comparable Class II restorations in posterior teeth
  • Good general and oral health
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Patients with systemic diseases affecting oral health
  • Pregnant or lactating women
  • Poor oral hygiene or high caries risk
  • Teeth with pulp involvement or periapical pathology
  • History of allergy to dental materials used in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Bezmialem Vakif University

Istanbul, Turkey (Türkiye), 34093

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here