Comparing a bioactive bulk-fill layer plus microhybrid versus microhybrid alone for Class II back-tooth restorations
Official title: Clinical Performance of a Bioactive Bulk-Fill Composite in Class II Restorations: A Prospective Split-Mouth Study
Run by Bezmialem Vakif University · NCT07547904 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Bezmialem Vakif University Academic / other |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | February 5, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | August 30, 2027 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07547904 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Bezmialem Vakif University
Istanbul, Turkey (Türkiye) Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Silver Diamine Fluoride for Caries in Baby Teeth in Routine Dental Care
This study tests whether applying 38% silver diamine fluoride in everyday dental practice can stop decay in primary teeth of children 14 and younger.
-
Nano Silver Fluoride vs. Silver Diamine Fluoride for Kids’ Cavities
This study tests whether Nano Silver Fluoride can stop decay in children as well as Silver Diamine Fluoride.
-
Digital Caries Risk Questionnaire: does it match CAMBRA in Egyptian adults
A digital self‑administered caries risk questionnaire is being tested to see how well it matches the CAMBRA risk assessment in Egyptian adults who visit the dentist.
-
First permanent molars restored with Cention N in children
This trial tests whether restoring both first permanent molars with Cention N in children aged 8-10 is beneficial for clinical results, x-ray findings, and daily oral health quality of life over 12 months.
-
Ozone therapy to boost remineralization of early caries in kids
This study tests whether adding ozone therapy to a remineralizing gel helps children aged 6–12 remineralize early, non-cavitated caries lesions better than the gel alone.
-
Dental health in children with specific learning disabilities
This study will test the dental caries and oral hygiene of 7–12 year-olds with specific learning disabilities and compare them with healthy peers.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.