Dental CariesBioactiveNCT07394751
Clinical Performance of Bioactive Restorative Materials
A study testing Tetric N Ceram Bulkfill application, Cention Forte application and Stela Automix in people with Dental Caries and Dental Adhesive Materials, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to evaluate the performance of three different bioactive restorative materials against a composite resin for a period of 9 months. This randomized, split-mouth, single-center trial was performed on patients having occlusal caries (ICDAS 3 and 4) in both molars of the same jaw. Read more about this study
- Who is it for?
- Ages 20 to 34 years
- Conditions the study is for
- Dental Caries, Dental Adhesive Materials
- What is being tested?
- Tetric N Ceram Bulkfill application, Cention Forte application and Stela Automix
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Nov 2026
- 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 20 to 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals over the age of 16 with permanent dentition
- Individuals with a total of four vital molar teeth requiring restoration (ICDAS 3-4), two on each side of the same jaw
- Individuals with posterior contact with antagonist teeth
- Individuals who are reliable, cooperative, and willing to participate in periodic follow-ups
Who cannot join
- Individuals whose antagonist teeth were missing or have crowns, bridges, etc.
- Individuals with history of alcohol, drug, or medication addiction.
- Individuals with pulp exposure during cavity preparation or a cavity depth exceeding 2-4 mm.
- Individuals known to be unable to attend follow-up appointments.
- Individuals with allergies to the products used in the procedure.
- Individuals with severe tooth grinding or bruxism.
- Individuals with caries conditions classified as ICDAS 5 and 6.
- Pregnant or breastfeeding individuals and individuals planning pregnancy during the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Dentistry
Izmir, Bornova, 35100
About this study
Official title: Clinical Performance of Bioactive Restorative Materials in Occlusal Restorations: Preliminary Results of a Split-mouth Study
The aim of this clinical study is to evaluate the performance of three different bioactive restorative materials against a composite resin for a period of 9 months.
This randomized, split-mouth, single-center trial was performed on patients having occlusal caries (ICDAS 3 and 4) in both molars of the same jaw. The restorative materials used were Tetric N-Ceram Bulk-fill (control, Ivoclar Vivadent, Liechtenstein), Stela (SDI, Australia), Cention Forte (Ivoclar) and Activa BioActive Restorative (Pulpdent, USA). The restorations were evaluated at baseline, 3-6 and 9-month according to FDI-2 criteria, in terms of functional, biological, and aesthetic parameters, by two experienced evaluators.
Read the detailed description
Objectives: To clinically evaluate the performance of three different bioactive restorative materials against a composite resin for a period of 9 months.
Materials and Methods: This randomized, split-mouth, single-center trial was performed on patients having occlusal caries (ICDAS 3 and 4) in both molars of the same jaw. The restorative materials used were Tetric N-Ceram Bulk-fill (control, Ivoclar Vivadent, Liechtenstein), Stela (SDI, Australia), Cention Forte (Ivoclar) and Activa BioActive Restorative (Pulpdent, USA). The material allocation was randomly assigned by a drawing lot. The restorations were evaluated at baseline, 3-6 and 9-month according to FDI-2 criteria, in terms of functional, biological, and aesthetic parameters, by two experienced evaluators. Chi-square test was used to compare the variables in the categories. Mann-Whitney U test and paired T test compared the difference in scores for the groups (p<0.05).
- Conditions
- Dental Caries, Dental Adhesive Materials
- Being tested
- Tetric N Ceram Bulkfill application, Cention Forte application, Stela Automix, Activa BioActive Restorative
- Keywords
- Bioactive Restorative Materials, Dental Restorations, Clinical trial, FDI-2 criteria
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetric N Ceram Bulkfill applicationProcedure or surgery
Selective enamel etching was performed with 37% phosphoric acid followed by a universal adhesive system application to all cavity surfaces and LED cured. The bulk-fill composite resin was placed in a single increment according to the manufacturer's recommendations and light-cured for 20 seconds. Excess material was removed using flame-shaped diamond finishing burs. Occlusion was assessed with articulation paper, and premature or undesirable contact points were adjusted as necessary.
Cention Forte applicationProcedure or surgery
A drop of Cention Primer was mixed in its wheel for 5 seconds and actively applied to the cavity for 10 seconds, followed by gentle air-drying. The Cention Forte capsule was then mixed for 15 seconds in a capsule mixer and placed in bulk into the prepared cavity using the manufacturer's delivery gun. Light curing was performed for 20 seconds with an LED unit (1300 mW/cm²; ZenoLite, President, Germany). Excess material was removed using flame-shaped diamond finishing burs. Occlusion was assessed with articulation paper, and any premature or undesirable contact points were adjusted accordingly. Final polishing was performed with OptraGloss polishing wheels (Ivoclar Vivadent) for 20 seconds.
Stela AutomixProcedure or surgery
Stela Primer was applied to the cavity surfaces and margins for 10 seconds. After a 5-second waiting period, the primer was gently air-dried for 2-3 seconds. The Stela Automix injector tip was then angled as needed and inserted into the cavity to deliver the material. The restoration was allowed to self-cure for 4 minutes. Occlusion was evaluated using articulation paper, and any premature or undesired contact points were adjusted as necessary. Final polishing was performed with OptraGloss polishing wheels (Ivoclar Vivadent) for 20 seconds.
Activa BioActive RestorativeProcedure or surgery
Selective enamel etching was performed with 37% phosphoric acid for 15 seconds, followed by thorough rinsing and air-drying. A universal adhesive system (Tetric N-Bond Universal, Ivoclar Vivadent) was applied to all cavity surfaces, including enamel, for 20 seconds, air-thinned, and light-cured for 20 seconds using an LED unit (1300 mW/cm²; ZenoLite, President, Germany). Following the manufacturer's instructions, the placement tip was inserted into the cavity using the dedicated placement gun, and the material was delivered in bulk. Light curing was performed for 20 seconds. Excess material was removed using flame-shaped diamond finishing burs. Occlusion was assessed with articulation paper, and premature or undesirable contact points were adjusted as needed. Final polishing was performed with OptraGloss polishing wheels (Ivoclar Vivadent) for 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Tetric N-Ceram BulkFill | Active comparator | Tetric N-Ceram Bulkfill application (control group; device 1) was randomly applied to patients. Receives: Procedure: Tetric N Ceram Bulkfill application |
| Cention Forte | Active comparator | Cention Forte was randomly applied to patients. Receives: Procedure: Cention Forte application |
| Stela Automix | Active comparator | Stela automix was randomly applied to patients. Receives: Procedure: Stela Automix |
| Activa BioActive Restorative | Active comparator | Activa BioActive Restorative was randomly applied to patients. Receives: Procedure: Activa BioActive Restorative |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDI-2 evaluation criteria for functional properties
Clinical evaluations were conducted using the FDI-2 criteria by two experienced, calibrated, and blinded evaluators for functional properties (category F). fracture/displacement of the material, marginal adaptation, form and contour, occlusion, and wear) were scored. Scores of 1-3 indicate clinically acceptable and successful restorations, score 4 indicates clinically inadequate but repairable defects, and score 5 represents clinically unacceptable restorations.
Measured: 2 years
Secondary outcomes (1)
FDI-2 evaluation criteria for biological properties
Clinical evaluations were conducted using the FDI-2 criteria by two experienced, calibrated, and blinded evaluators for biological properties (category B). Secondary caries, integrity of tooth structure at restoration margins, post-operative sensitivity, and pulp status) were scored. Scores of 1-3 indicate clinically acceptable and successful restorations, score 4 indicates clinically inadequate but repairable defects, and score 5 represents clinically unacceptable restorations.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Nov 2024
- Primary completion1 Apr 2025
- Study completion1 Nov 2026 (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 Ege 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
- Randomized split mouth study design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebnem Turkun, Ege University
- Investigators
- Cankut Canevi, DDS, Principal investigator, Ege University School of Dentistry Department of Restorative Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394751
- Sponsor's protocol ID
- E-68869993-000-1477638
- Other IDs
- 224S847
- Acronym
- Bioactive
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Bioactive Restorative Materials in Occlusal Restorations: Preliminary Results of a Split-mouth Study
- ClinicalTrials.gov ID
- NCT07394751
- Acronym / sponsor ID
- Bioactive / E-68869993-000-1477638
- Conditions
- Dental Caries, Dental Adhesive Materials
- Keywords
- Bioactive Restorative Materials, Dental Restorations, Clinical trial, FDI-2 criteria
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 6 Feb 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.
The aim of this clinical study is to evaluate the performance of three different bioactive restorative materials against a composite resin for a period of 9 months.
This randomized, split-mouth, single-center trial was performed on patients having occlusal caries (ICDAS 3 and 4) in both molars of the same jaw. The restorative materials used were Tetric N-Ceram Bulk-fill (control, Ivoclar Vivadent, Liechtenstein), Stela (SDI, Australia), Cention Forte (Ivoclar) and Activa BioActive Restorative (Pulpdent, USA). The restorations were evaluated at baseline, 3-6 and 9-month according to FDI-2 criteria, in terms of functional, biological, and aesthetic parameters, by two experienced evaluators.
Detailed description
Objectives: To clinically evaluate the performance of three different bioactive restorative materials against a composite resin for a period of 9 months.
Materials and Methods: This randomized, split-mouth, single-center trial was performed on patients having occlusal caries (ICDAS 3 and 4) in both molars of the same jaw. The restorative materials used were Tetric N-Ceram Bulk-fill (control, Ivoclar Vivadent, Liechtenstein), Stela (SDI, Australia), Cention Forte (Ivoclar) and Activa BioActive Restorative (Pulpdent, USA). The material allocation was randomly assigned by a drawing lot. The restorations were evaluated at baseline, 3-6 and 9-month according to FDI-2 criteria, in terms of functional, biological, and aesthetic parameters, by two experienced evaluators. Chi-square test was used to compare the variables in the categories. Mann-Whitney U test and paired T test compared the difference in scores for the groups (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized split mouth study design
| Arm | Type | Receives |
|---|---|---|
| Tetric N-Ceram BulkFill | Active comparator | Procedure: Tetric N Ceram Bulkfill applicationTetric N-Ceram Bulkfill application (control group; device 1) was randomly applied to patients. |
| Cention Forte | Active comparator | Procedure: Cention Forte applicationCention Forte was randomly applied to patients. |
| Stela Automix | Active comparator | Procedure: Stela AutomixStela automix was randomly applied to patients. |
| Activa BioActive Restorative | Active comparator | Procedure: Activa BioActive RestorativeActiva BioActive Restorative was randomly applied to patients. |
Who may qualify
- Ages
- 20 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals over the age of 16 with permanent dentition
- Individuals with a total of four vital molar teeth requiring restoration (ICDAS 3-4), two on each side of the same jaw
- Individuals with posterior contact with antagonist teeth
- Individuals who are reliable, cooperative, and willing to participate in periodic follow-ups
Key exclusion criteria (8 listed)
- Individuals whose antagonist teeth were missing or have crowns, bridges, etc.
- Individuals with history of alcohol, drug, or medication addiction.
- Individuals with pulp exposure during cavity preparation or a cavity depth exceeding 2-4 mm.
- Individuals known to be unable to attend follow-up appointments.
- Individuals with allergies to the products used in the procedure.
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 |
|---|---|---|
| Tetric N Ceram Bulkfill applicationSelective enamel etching was performed with 37% phosphoric acid followed by a universal adhesive system application to all cavity surfaces and LED cured. The bulk-fill composite resin was placed in a single increment according to the manufacturer's recommendations and light-cured for 20 seconds. Excess material was removed using flame-shaped diamond finishing burs. Occlusion was assessed with articulation paper, and premature or undesirable contact points were adjusted as necessary. | Procedure or surgery | Tetric N-Ceram BulkFill |
| Cention Forte applicationA drop of Cention Primer was mixed in its wheel for 5 seconds and actively applied to the cavity for 10 seconds, followed by gentle air-drying. The Cention Forte capsule was then mixed for 15 seconds in a capsule mixer and placed in bulk into the prepared cavity using the manufacturer's delivery gun. Light curing was performed for 20 seconds with an LED unit (1300 mW/cm²; ZenoLite, President, Germany). Excess material was removed using flame-shaped diamond finishing burs. Occlusion was assessed with articulation paper, and any premature or undesirable contact points were adjusted accordingly. Final polishing was performed with OptraGloss polishing wheels (Ivoclar Vivadent) for 20 seconds. | Procedure or surgery | Cention Forte |
| Stela AutomixStela Primer was applied to the cavity surfaces and margins for 10 seconds. After a 5-second waiting period, the primer was gently air-dried for 2-3 seconds. The Stela Automix injector tip was then angled as needed and inserted into the cavity to deliver the material. The restoration was allowed to self-cure for 4 minutes. Occlusion was evaluated using articulation paper, and any premature or undesired contact points were adjusted as necessary. Final polishing was performed with OptraGloss polishing wheels (Ivoclar Vivadent) for 20 seconds. | Procedure or surgery | Stela Automix |
| Activa BioActive RestorativeSelective enamel etching was performed with 37% phosphoric acid for 15 seconds, followed by thorough rinsing and air-drying. A universal adhesive system (Tetric N-Bond Universal, Ivoclar Vivadent) was applied to all cavity surfaces, including enamel, for 20 seconds, air-thinned, and light-cured for 20 seconds using an LED unit (1300 mW/cm²; ZenoLite, President, Germany). Following the manufacturer's instructions, the placement tip was inserted into the cavity using the dedicated placement gun, and the material was delivered in bulk. Light curing was performed for 20 seconds. Excess material was removed using flame-shaped diamond finishing burs. Occlusion was assessed with articulation paper, and premature or undesirable contact points were adjusted as needed. Final polishing was performed with OptraGloss polishing wheels (Ivoclar Vivadent) for 20 seconds. | Procedure or surgery | Activa BioActive Restorative |
Primary outcome
FDI-2 evaluation criteria for functional properties
Time frame: 2 years
Clinical evaluations were conducted using the FDI-2 criteria by two experienced, calibrated, and blinded evaluators for functional properties (category F). fracture/displacement of the material, marginal adaptation, form and contour, occlusion, and wear) were scored. Scores of 1-3 indicate clinically acceptable and successful restorations, score 4 indicates clinically inadequate but repairable defects, and score 5 represents clinically unacceptable restorations.
1 secondary outcome
FDI-2 evaluation criteria for biological properties
Time frame: 2 years
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 6 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Cankut Canevi, DDS principal investigator
Ege University School of Dentistry Department of Restorative Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetric N Ceram Bulkfill application, Cention Forte application and Stela Automix in people with Dental Caries and Dental Adhesive Materials, run by Ege 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 8 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: under way, not looking for participants, as of the sponsor's last update on 6 Feb 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FDI-2 evaluation criteria for functional properties (time frame: 2 years). 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 6 Feb 2026.