Actively Recruiting
Clinical Performance of a Bioactive Bulk-Fill Composite in Class II Restorations: A Prospective Split-Mouth Study
Led by Bezmialem Vakif University · Updated on 2026-04-23
34
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical performance of a bioactive bulk-fill composite compared to a conventional microhybrid composite in Class II posterior dental restorations. This prospective split-mouth study includes adults aged 18 to 50 years who require at least two comparable Class II restorations. The study aims to provide evidence on the effectiveness of bioactive bulk-fill composites in improving restoration outcomes by comparing two different restorative approaches within the same individual. Participants will receive two different treatments: one cavity will be restored using a bioactive bulk-fill composite (Activa BioACTIVE Bulk Flow) applied at the gingival base and covered with a microhybrid composite (Filtek Z250), while the other cavity will be restored entirely with the microhybrid composite (Filtek Z250). This split-mouth design allows direct comparison of the two materials within the same mouth, minimizing variability. Clinical performance will be assessed at baseline, 6 months, and 12 months using the FDI World Dental Federation criteria, focusing on marginal adaptation, retention, and overall clinical success of the restorations. Secondary outcomes include evaluating surface properties and marginal staining. Participants will undergo dental evaluations at these intervals to monitor outcomes and ensure safety throughout the study, which is expected to last at least 12 months per participant.
CONDITIONS
Brief Title
Clinical Performance of Bioactive Bulk-Fill in Class II Restorations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single dental treatment session
Participants receive dental restorations using either the bioactive bulk-fill composite or the conventional composite in Class II cavities.
1 visit (in-person)
Duration - 12 months
Participants are monitored to assess the clinical performance and surface properties of the restorations.
3 visits at baseline, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Bezmialem Vakif University
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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