Bioactive Bulk-Fill vs Microhybrid in Class II Restorations
ClinicalTrials.gov Studies
Summary
A prospective split-mouth clinical study registered on ClinicalTrials.gov (NCT07547904) will compare the clinical performance of a bioactive bulk-fill composite (Activa BioACTIVE Bulk Flow) against a conventional microhybrid composite (Filtek Z250) in Class II posterior restorations. The trial will enroll participants receiving both restorative approaches, with evaluations at baseline, 6 months, and 12 months using FDI World Dental Federation criteria. Primary outcomes include marginal adaptation, retention, and overall clinical success; secondary outcomes include surface properties and marginal staining.
“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.”
About this source
ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.
What changed
This ClinicalTrials.gov registry entry documents a new prospective split-mouth clinical study evaluating bioactive bulk-fill composite against conventional microhybrid composite in Class II posterior restorations. The trial will use FDI World Dental Federation criteria to assess marginal adaptation, retention, surface properties, and marginal staining at 6-month and 12-month intervals. The split-mouth design enables intra-individual comparison, reducing variability and strengthening study conclusions.
Healthcare providers and clinical investigators conducting or considering posterior restorative procedures should note this trial as a potential source of evidence on whether bioactive bulk-fill materials offer superior clinical performance. The study does not create compliance obligations but may inform future clinical practice guidelines for dental restorative materials.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Clinical Performance of Bioactive Bulk-Fill in Class II Restorations
N/A NCT07547904 Kind: NA Apr 23, 2026
Abstract
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
Interventions: Activa BioACTIVE Bulk Flow, Filtek Z250
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.