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Clinical Performance of Bioactive Bulk-Fill in Class II Restorations
Sponsor: Bezmialem Vakif University
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
Activa BioACTIVE Bulk Flow
Bioactive bulk-fill composite material used at the gingival base in Class II restorations.
Filtek Z250
Conventional microhybrid composite used for full restoration in Class II cavities.
Locations (1)
Bezmialem Vakif University
Istanbul, Turkey (Türkiye)