NCT07547904 Clinical Performance of Bioactive Bulk-Fill in Class II Restorations
| NCT ID | NCT07547904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bezmialem Vakif University |
| Condition | Dental Caries |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2026-02-05 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2026-02-05 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07547904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Dental Caries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07547904 currently recruiting?
Yes, NCT07547904 is actively recruiting participants. Visit ClinicalTrials.gov or contact Bezmialem Vakif University to inquire about joining.
Where is the NCT07547904 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07547904 clinical trial?
NCT07547904 is sponsored by Bezmialem Vakif University. The trial plans to enroll 34 participants.