About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Activa BioACTIVE Bulk Flow
DeviceBioactive bulk-fill composite material used at the gingival base in Class II restorations.
Filtek Z250
DeviceConventional microhybrid composite used for full restoration in Class II cavities.
Treatment groups
Trial outcomes
Primary outcomes
Clinical performance of restorations (FDI criteria)
Evaluation of restorations according to FDI criteria including marginal adaptation, retention, and overall clinical success.
Secondary outcomes
Marginal discoloration and surface properties
Assessment of marginal staining and surface characteristics of restorations based on FDI criteria.
Sponsors and contacts
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