Clinical Performance of Bioactive Bulk-Fill in Class II Restorations

April 17, 2026 updated by: Bezmialem Vakif University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bioactive Bulk-Fill Composite
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
Bioactive bulk-fill composite material used at the gingival base in Class II restorations.
Active Comparator: Conventional Composite
Restorations performed entirely using microhybrid composite (Filtek Z250).
Device: Filtek Z250
Conventional microhybrid composite used for full restoration in Class II cavities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bezmialem-RDT-2026-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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