Clinical Performance of Bioactive Bulk-Fill in Class II Restorations

ConditionDental Caries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorBezmialem Vakif University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Activa BioACTIVE Bulk Flow

    Device

    Bioactive bulk-fill composite material used at the gingival base in Class II restorations.

  • Filtek Z250

    Device

    Conventional microhybrid composite used for full restoration in Class II cavities.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Bioactive Bulk-Fill CompositeExperimental treatment 1 intervention
Group B: Conventional CompositeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical performance of restorations (FDI criteria)

Evaluation of restorations according to FDI criteria including marginal adaptation, retention, and overall clinical success.

Time frame
Baseline, 6 months, and 12 months

Secondary outcomes

1

Marginal discoloration and surface properties

Assessment of marginal staining and surface characteristics of restorations based on FDI criteria.

Time frame
Baseline, 6 months, and 12 months

Other outcomes

Sponsors and contacts

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