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NCT Number: NCT07547904

Clinical Performance of Bioactive Bulk-Fill in Class II Restorations

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location status: Recruiting

Location contact

Zümrüt Ceren Özduman, DDS, PhD

CONTACT

[email protected]

+905364000171

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Clinical performance of restorations (FDI criteria)

    Time frame: Baseline, 6 months, and 12 months

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

Secondary outcomes

  1. Marginal discoloration and surface properties

    Time frame: Baseline, 6 months, and 12 months

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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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