Clinical Performance of Bioactive Bulk-Fill in Class II Restorations

NCT07547904 | Recruiting

• 1 other identifier: Bezmialem-RDT-2026-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Clinical performance of restorations (FDI criteria)

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

  Baseline, 6 months, and 12 months

Secondary Outcomes (1)

• Marginal discoloration and surface properties

  Baseline, 6 months, and 12 months

Study Arms (2)

Bioactive Bulk-Fill Composite

EXPERIMENTAL

Bioactive bulk-fill composite (Activa BioACTIVE Bulk Flow) applied at the gingival base and covered with microhybrid composite (Filtek Z250).

Device: Activa BioACTIVE Bulk Flow

Conventional Composite

ACTIVE COMPARATOR

Restorations performed entirely using microhybrid composite (Filtek Z250).

Device: Filtek Z250

Interventions

Activa BioACTIVE Bulk Flow DEVICE

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

Bioactive Bulk-Fill Composite

Filtek Z250 DEVICE

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

Conventional Composite

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: split mouth

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

TU (1)