Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Bezmialem Vakif University
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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