Bezmialem Vakif University
Istanbul, 34093, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07547904
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.
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Not applicable
Istanbul, 34093, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bioactive bulk-fill composite material used at the gingival base in Class II restorations.
Conventional microhybrid composite used for full restoration in Class II cavities.
Time frame: Baseline, 6 months, and 12 months
Evaluation of restorations according to FDI criteria including marginal adaptation, retention, and overall clinical success.
Time frame: Baseline, 6 months, and 12 months
Assessment of marginal staining and surface characteristics of restorations based on FDI criteria.
Bezmialem Vakif University
Other
Clinical Performance of a Bioactive Bulk-Fill Composite in Class II Restorations: A Prospective Split-Mouth Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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