Comparing a bioactive bulk-fill layer plus microhybrid versus microhybrid alone for Class II back-tooth restorations
Clinical Performance of a Bioactive Bulk-Fill Composite in Class II Restorations: A Prospective Split-Mouth Study
NA · Bezmialem Vakif University · NCT07547904
This study will test whether placing a bioactive bulk-fill layer under a standard microhybrid filling leads to better fit, retention, and less staining for adults who need two similar Class II back-tooth restorations.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Bezmialem Vakif University (other) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07547904 on ClinicalTrials.gov |
What this trial studies
This is a prospective split-mouth clinical study in which each participant receives two comparable Class II posterior restorations, allowing direct intra-individual comparison. In the experimental approach, a bioactive bulk-fill composite (Activa BioACTIVE Bulk Flow) is placed at the gingival base and covered with a microhybrid composite (Filtek Z250), while the control restorations are completed entirely with Filtek Z250. Clinical performance will be scored using FDI World Dental Federation criteria at baseline, 6 months, and 12 months, with primary outcomes of marginal adaptation, retention, and overall clinical success and secondary outcomes including surface properties and marginal staining. The trial will be conducted at Bezmialem Vakif University and enrol adults aged 18–50 who need at least two comparable Class II restorations and are in good general and oral health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–50 in good general and oral health who require at least two comparable Class II posterior restorations and can attend follow-up visits and provide informed consent.
Not a fit: Patients with systemic diseases affecting oral health, high caries risk or poor oral hygiene, pregnant or lactating women, teeth with pulp involvement or periapical pathology, or those with a known allergy to the study materials are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could lead to longer-lasting posterior fillings with fewer marginal gaps and less staining.
How similar studies have performed: Laboratory studies and limited short-term clinical reports on bioactive bulk-fill materials have shown promising results for marginal sealing and resistance to staining, but robust long-term clinical evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Istanbul
- Bezmialem Vakif University — Istanbul, Turkey (Türkiye) (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dental Caries