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RECRUITING
NCT07547904
NA

Clinical Performance of Bioactive Bulk-Fill in Class II Restorations

Sponsor: Bezmialem Vakif University

View on ClinicalTrials.gov

Summary

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.

Official title: Clinical Performance of a Bioactive Bulk-Fill Composite in Class II Restorations: A Prospective Split-Mouth Study

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2026-02-05

Completion Date

2027-08-30

Last Updated

2026-04-23

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Activa BioACTIVE Bulk Flow

Bioactive bulk-fill composite material used at the gingival base in Class II restorations.

DEVICE

Filtek Z250

Conventional microhybrid composite used for full restoration in Class II cavities.

Locations (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)