Dental Caries
Conditions
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.
Interventions
DEVICEActiva BioACTIVE Bulk Flow
Bioactive bulk-fill composite material used at the gingival base in Class II restorations.
DEVICEFiltek Z250
Conventional microhybrid composite used for full restoration in Class II cavities.
Sponsors
Bezmialem Vakif University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
split mouth
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance of restorations (FDI criteria) | Baseline, 6 months, and 12 months | Evaluation of restorations according to FDI criteria including marginal adaptation, retention, and overall clinical success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal discoloration and surface properties | Baseline, 6 months, and 12 months | Assessment of marginal staining and surface characteristics of restorations based on FDI criteria. |
Countries
Turkey (Türkiye)
Outcome results
None listed