Phase None Recruiting NCT07547904

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

Bezmialem Vakif University · Interventional, Randomized · n=34

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Currently enrolling. Learn more about participation on ClinicalTrials.gov →
Study context Single-site study

Overview

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.

Full record on ClinicalTrials.gov (NCT ID NCT07547904).

Eligibility

Age range: 18–50 · Sex: All · Healthy volunteers: Requires diagnosis

Study design

Phase
Phase None
Study type
Interventional
Allocation
Randomized
Masking
Single-blind
Intervention model
Parallel assignment
Primary purpose
Treatment
Enrollment target
34 participants
Started
February 2026
Estimated completion
August 2027

Outcome measures

Locations & contactsi

Filter by location Showing 1 of 1 sites

1 site currently enrolling. Representative sites shown below; full site list on ClinicalTrials.gov.

Bezmialem Vakif University — Istanbul (Turkey (Türkiye))

Sources

REG
ClinicalTrials.gov — NCT07547904
Trial registry · primary record
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