Dental CariesNCT07547904
Clinical Performance of Bioactive Bulk-Fill in Class II Restorations
A study testing Activa BioACTIVE Bulk Flow and Filtek Z250 in people with Dental Caries, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Activa BioACTIVE Bulk Flow and Filtek Z250
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, 34093
Zümrüt Ceren Özduman, DDS, PhD, +905364000171, zoduman@bezmialem.edu.tr
About this study
Official title: Clinical Performance of a Bioactive Bulk-Fill Composite in Class II Restorations: A Prospective Split-Mouth Study
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.
- Conditions
- Dental Caries
- Being tested
- Activa BioACTIVE Bulk Flow, Filtek Z250
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activa BioACTIVE Bulk FlowDevice
Bioactive bulk-fill composite material used at the gingival base in Class II restorations.
Filtek Z250Device
Conventional microhybrid composite used for full restoration in Class II cavities.
| Study group | Role | What they receive |
|---|---|---|
| Bioactive Bulk-Fill Composite | Experimental | Bioactive bulk-fill composite (Activa BioACTIVE Bulk Flow) applied at the gingival base and covered with microhybrid composite (Filtek Z250). Receives: Device: Activa BioACTIVE Bulk Flow |
| Conventional Composite | Active comparator | Restorations performed entirely using microhybrid composite (Filtek Z250). Receives: Device: Filtek Z250 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of restorations (FDI criteria)
Evaluation of restorations according to FDI criteria including marginal adaptation, retention, and overall clinical success.
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (1)
Marginal discoloration and surface properties
Assessment of marginal staining and surface characteristics of restorations based on FDI criteria.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start5 Feb 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split mouth
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547904
- Sponsor's protocol ID
- Bezmialem-RDT-2026-01
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a Bioactive Bulk-Fill Composite in Class II Restorations: A Prospective Split-Mouth Study
- ClinicalTrials.gov ID
- NCT07547904
- Acronym / sponsor ID
- Bezmialem-RDT-2026-01
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- split mouth
| Arm | Type | Receives |
|---|---|---|
| Bioactive Bulk-Fill Composite | Experimental | Device: Activa BioACTIVE Bulk FlowBioactive bulk-fill composite (Activa BioACTIVE Bulk Flow) applied at the gingival base and covered with microhybrid composite (Filtek Z250). |
| Conventional Composite | Active comparator | Device: Filtek Z250Restorations performed entirely using microhybrid composite (Filtek Z250). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activa BioACTIVE Bulk FlowBioactive bulk-fill composite material used at the gingival base in Class II restorations. | Device | Bioactive Bulk-Fill Composite |
| Filtek Z250Conventional microhybrid composite used for full restoration in Class II cavities. | Device | Conventional Composite |
Primary outcome
Clinical performance of restorations (FDI criteria)
Time frame: Baseline, 6 months, and 12 months
Evaluation of restorations according to FDI criteria including marginal adaptation, retention, and overall clinical success.
1 secondary outcome
Marginal discoloration and surface properties
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activa BioACTIVE Bulk Flow and Filtek Z250 in people with Dental Caries, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of restorations (FDI criteria) (time frame: Baseline, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.