Class II Dental CariesNCT06212141
Comparison of Bulk-Fill Composite Resins in Class II Restorations
A study testing VisCalor Bulk,VOCO,Germany, Admira Fusion x-tra,VOCO,Germany and Filtek One Bulk,3M,Germany in people with Class II Dental Caries, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins . Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Dental Caries
- What is being tested?
- VisCalor Bulk,VOCO,Germany, Admira Fusion x-tra,VOCO,Germany and Filtek One Bulk,3M,Germany
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2022to 15 Jun 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals without any systemic disease
- Patients who is between 18 and 60 years old,
- Patiens who brush their teeth 2 times a day
- Voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment.
Who cannot join
- Women who are pregnant or breastfeeding
- Patients with advanced periodontial disease
- Patiens using a moving segmental prosthesis
- Patiens who have maloclusions,
- Patiens who have bruxism,
- Patients with known allergies to resin-based restorative materials and binding agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparison of Convetional Bulk-Fill Composite Resins and Thermoviscous Bulk-Fill Composite Resins in Class II Restorations
The goal of this clinical trial is to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins .
Class II restorations will be performed in patients using three different restorative materials.And restorations will be evaluated using modified US Public Health Service criteria Resorations will be photograped and restorations will be evaluated for 6,12 months.
Read the detailed description
The aim of this clinical study was to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins.
Methods and Materials: Class II restorations will be performed in patients using three different restorative materials: VisCalor Thermoviscous Bulk-Fill (VCB; a thermoviscous nanohybrid bulk-fill composite resin) , Admira Fusion x-tra ( AFT: a conventional nanohybrid bulk-fill composite resin) and 3M Filtek One Bulk-Fill Restprative (FOB: a conventional bulk-fill nanocomposite ) Futura Bond U adhesive will be used for both conventional bulk-fill composite resin restorations and thermoviscous bulk-fill composite resin restorations.
Criteria for inclusion of patients in the study : Healthy individuals without any systemic disease, patients who is between 18 and 60 years old, patiens who brush their teeth 2 times a day,voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment.
Criteria for not inclusion of volunteers in research:Women who are pregnant or breastfeeding ,patienrs with advanced periodontial disease,patiens using a moving segmental prosthesis,patiens who have maloclusions,patiens who have bruxism,patients with known allergies to resin-based restorative materials and binding agents
The restorations will be evaluated using modified US Public Health Service criteria in terms of retention, color match, marginal discoloration, anatomic form, marginal adaptation, secondary caries, postoperative sensitivity, and surface texture. Resorations will be photograped and restorations will be evaluated for 6,12 months
.
- Conditions
- Class II Dental Caries
- Being tested
- VisCalor Bulk,VOCO,Germany, Admira Fusion x-tra,VOCO,Germany, Filtek One Bulk,3M,Germany
- Keywords
- Bulk-Fill Composite, Thermoviscous Bulk-Fill Composite, Class II Restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisCalor Bulk,VOCO,GermanyDevice
It was placed class II restorations.Before applying it, a 37% orthophosphoric acid will be injected into the cavity for 30 sec. on the enamel and 15 sec. on the dentin. Then, cavity will be rinsed with pressurized air and water for 15 sec. and Futura Bond U adhesive agent will be applied to the enamel and dentin surfaces using a disposable applicator for 20 sec. Then light air pressure will be applied for 5 sec., and then polymerization will be carried out for 10 sec. using LED light.
When it comes to the application of VisCalor , the VisCalor Gun , heating device will be used. A disposable composite capsule will be placed into the device, and it will be heated by selecting program 1 (65°C) for 30 sec. The material will remain hot for 2.5 min.
The nozzle of the capsule on the gun will be directly applied to the deepest part of the cavity, ensuring that the material is placed from bottom to top without exceeding 4 mm. Polymerization will be carried out with LED for 10 sec.
Admira Fusion x-tra,VOCO,GermanyDevice
Admira Fusion x-tra composite resin was placed class II restorations. Before applying it an orthophosphoric acid with a concentration of 37% will be injected into the cavity for 30 sec. on the enamel and 15 sec. on the dentin. Then, cavity will be rinsed with pressurized air and water for 20 sec. And Futura Bond U adhesive agent will be applied to the enamel and dentin surfaces using a disposable applicator for 20 sec. Following the manufacturer's recommendations, light air pressure will be applied for 5 sec, and then polymerization will be carried out for 10 sec. using LED light with a power of 1200 mW/cm².
Afterwards bulk-fill composite will be placed in the cavity, ensuring that each layer does not exceed 4 mm, and appropriate occlusal shaping will be performed. Polymerization will be carried out with LED light for 20 seconds.
Filtek One Bulk,3M,GermanyDevice
Filtek One Bulk composite resin was placed class II restorations. Before applyingthe material, a 37% orthophosphoric acid will be injected into the cavity for 30 sec. on the enamel and 15 sec. on the dentin, followed by rinsing the cavity with pressurized air and water for 20 sec.Then , adhesive agent will be applied to the enamel and dentin surfaces using a disposable applicator for 20 sec. Following the manufacturer's recommendations, light air pressure will be applied for 5 sec, and then polymerization will be carried out for 10 sec using LED light .
Afterwards, bulk-fill composite will be placed in the cavity, ensuring that each layer does not exceed 4 mm, and appropriate occlusal shaping will be performed. Polymerization will be carried out with LED light at a power of 1200 mW/cm² for 10 sec from all directions, following the manufacturer's recommendations.
| Study group | Role | What they receive |
|---|---|---|
| VisCalor Bulk | Active comparator | Thermoviscous Bulkfill composite resin Warming of the material makes it flowable for the application and then sculptable immediately afterwards (thermoviscous technology) Optimal flowing to margins and undercut regions One universal and three aesthetic shades Cannula form Receives: Device: VisCalor Bulk,VOCO,Germany |
| Admira Fusion x-tra | Active comparator | Ormocer based bulkfill composite Purely ceramic-based, bulk fill restorative material Reliable curing of 4 mm layersby far the lowest polymerisation shrinkage (1.25 % by volume) and particularly low level of shrinkage stress, providing optimal marginal integrity.
inert, so excellent biocompatible and extremely resistant to discolouration Easy handling, simple high-lustre polishing procedure coupled with high surface hardness guarantee first-class long-term results Universal shade with chameleon effect Receives: Device: Admira Fusion x-tra,VOCO,Germany |
| Filtek One Bulk | Active comparator | Conventional bulkfill compositeFocused options powered by 3M technology help you complete posterior restorations in a single bulk placement.
5 shades avaible : A1, A2, A3, B1, and C2. Excellent adaptation and sculptability for fast, easy placement. One-step placement : Tackle deep cavities with up to 5 mm depth of cure Receives: Device: Filtek One Bulk,3M,Germany |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Adaptation
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by an independent clinician. Visual inspection with a mirror was performed . Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed
Measured: From baseline to 18 month
Marginal Staining
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal staining. Marginal staining was evaluated by an independent clinician. Visual inspection with a mirror was performed . Scores: Alfa: No discoloration. Bravo: Discoloration without. Charlie: Discoloration with penetration in pulpal direction
Measured: From baseline to 18 month
Retention
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by an independent clinician. Scores: Alfa: No loss of restorative material. Charlie: Any loss of restorative material
Measured: From baseline to 18 month
Seconder caries
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by an independent clinician. Scores: Alfa: No caries present. Charlie: Caries present
Measured: From baseline to 18 month
Postoperative sensitivity
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by an independent clinician. Scores: Alfa: Not present. Bravo: sensitive but diminishing in intensity. . Charlie:constant sensitivity, not diminishing in intensity
Measured: From baseline to 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start12 Dec 2022
- Primary completion15 Jun 2024
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Class II Dental CariesStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Factorial
- Model description
- Randomized split-mouth clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meriç Tuncer, Hacettepe University
- Investigators
- Nurdan Meserret Başeren, Prof.Dr., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212141
- Sponsor's protocol ID
- KA-22065
- Status last verified
- Nov 2025
- First submitted
- 8 Jan 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chesterman J, Jowett A, Gallacher A, Nixon P. Bulk-fill resin-based composite restorative materials: a review. Br Dent J. 2017 Mar 10;222(5):337-344. doi: 10.1038/sj.bdj.2017.214.
PubMed 28281590
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Convetional Bulk-Fill Composite Resins and Thermoviscous Bulk-Fill Composite Resins in Class II Restorations
- ClinicalTrials.gov ID
- NCT06212141
- Acronym / sponsor ID
- KA-22065
- Conditions
- Class II Dental Caries
- Keywords
- Bulk-Fill Composite, Thermoviscous Bulk-Fill Composite, Class II Restorations
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 18 Jan 2024 (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 goal of this clinical trial is to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins .
Class II restorations will be performed in patients using three different restorative materials.And restorations will be evaluated using modified US Public Health Service criteria Resorations will be photograped and restorations will be evaluated for 6,12 months.
Detailed description
The aim of this clinical study was to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins.
Methods and Materials: Class II restorations will be performed in patients using three different restorative materials: VisCalor Thermoviscous Bulk-Fill (VCB; a thermoviscous nanohybrid bulk-fill composite resin) , Admira Fusion x-tra ( AFT: a conventional nanohybrid bulk-fill composite resin) and 3M Filtek One Bulk-Fill Restprative (FOB: a conventional bulk-fill nanocomposite ) Futura Bond U adhesive will be used for both conventional bulk-fill composite resin restorations and thermoviscous bulk-fill composite resin restorations.
Criteria for inclusion of patients in the study : Healthy individuals without any systemic disease, patients who is between 18 and 60 years old, patiens who brush their teeth 2 times a day,voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment.
Criteria for not inclusion of volunteers in research:Women who are pregnant or breastfeeding ,patienrs with advanced periodontial disease,patiens using a moving segmental prosthesis,patiens who have maloclusions,patiens who have bruxism,patients with known allergies to resin-based restorative materials and binding agents
The restorations will be evaluated using modified US Public Health Service criteria in terms of retention, color match, marginal discoloration, anatomic form, marginal adaptation, secondary caries, postoperative sensitivity, and surface texture. Resorations will be photograped and restorations will be evaluated for 6,12 months
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized split-mouth clinical trial
| Arm | Type | Receives |
|---|---|---|
| VisCalor Bulk | Active comparator | Device: VisCalor Bulk,VOCO,GermanyThermoviscous Bulkfill composite resin Warming of the material makes it flowable for the application and then sculptable immediately afterwards (thermoviscous technology) Optimal flowing to margins and undercut regions One universal and three aesthetic shades Cannula form |
| Admira Fusion x-tra | Active comparator | Device: Admira Fusion x-tra,VOCO,GermanyOrmocer based bulkfill composite Purely ceramic-based, bulk fill restorative material Reliable curing of 4 mm layersby far the lowest polymerisation shrinkage (1.25 % by volume) and particularly low level of shrinkage stress, providing optimal marginal integrity. inert, so excellent biocompatible and extremely resistant to discolouration Easy handling, simple high-lustre polishing procedure coupled with high surface hardness guarantee first-class long-term results Universal shade with chameleon effect |
| Filtek One Bulk | Active comparator | Device: Filtek One Bulk,3M,GermanyConventional bulkfill compositeFocused options powered by 3M technology help you complete posterior restorations in a single bulk placement. 5 shades avaible : A1, A2, A3, B1, and C2. Excellent adaptation and sculptability for fast, easy placement. One-step placement : Tackle deep cavities with up to 5 mm depth of cure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy individuals without any systemic disease
- Patients who is between 18 and 60 years old,
- Patiens who brush their teeth 2 times a day
- Voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment.
Key exclusion criteria (6 listed)
- Women who are pregnant or breastfeeding
- Patients with advanced periodontial disease
- Patiens using a moving segmental prosthesis
- Patiens who have maloclusions,
- Patiens who have bruxism,
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 |
|---|---|---|
| VisCalor Bulk,VOCO,GermanyIt was placed class II restorations.Before applying it, a 37% orthophosphoric acid will be injected into the cavity for 30 sec. on the enamel and 15 sec. on the dentin. Then, cavity will be rinsed with pressurized air and water for 15 sec. and Futura Bond U adhesive agent will be applied to the enamel and dentin surfaces using a disposable applicator for 20 sec. Then light air pressure will be applied for 5 sec., and then polymerization will be carried out for 10 sec. using LED light. When it comes to the application of VisCalor , the VisCalor Gun , heating device will be used. A disposable composite capsule will be placed into the device, and it will be heated by selecting program 1 (65°C) for 30 sec. The material will remain hot for 2.5 min. The nozzle of the capsule on the gun will be directly applied to the deepest part of the cavity, ensuring that the material is placed from bottom to top without exceeding 4 mm. Polymerization will be carried out with LED for 10 sec. | Device | VisCalor Bulk |
| Admira Fusion x-tra,VOCO,GermanyAdmira Fusion x-tra composite resin was placed class II restorations. Before applying it an orthophosphoric acid with a concentration of 37% will be injected into the cavity for 30 sec. on the enamel and 15 sec. on the dentin. Then, cavity will be rinsed with pressurized air and water for 20 sec. And Futura Bond U adhesive agent will be applied to the enamel and dentin surfaces using a disposable applicator for 20 sec. Following the manufacturer's recommendations, light air pressure will be applied for 5 sec, and then polymerization will be carried out for 10 sec. using LED light with a power of 1200 mW/cm². Afterwards bulk-fill composite will be placed in the cavity, ensuring that each layer does not exceed 4 mm, and appropriate occlusal shaping will be performed. Polymerization will be carried out with LED light for 20 seconds. | Device | Admira Fusion x-tra |
| Filtek One Bulk,3M,GermanyFiltek One Bulk composite resin was placed class II restorations. Before applyingthe material, a 37% orthophosphoric acid will be injected into the cavity for 30 sec. on the enamel and 15 sec. on the dentin, followed by rinsing the cavity with pressurized air and water for 20 sec.Then , adhesive agent will be applied to the enamel and dentin surfaces using a disposable applicator for 20 sec. Following the manufacturer's recommendations, light air pressure will be applied for 5 sec, and then polymerization will be carried out for 10 sec using LED light . Afterwards, bulk-fill composite will be placed in the cavity, ensuring that each layer does not exceed 4 mm, and appropriate occlusal shaping will be performed. Polymerization will be carried out with LED light at a power of 1200 mW/cm² for 10 sec from all directions, following the manufacturer's recommendations. | Device | Filtek One Bulk |
Primary outcome
Marginal Adaptation
Time frame: From baseline to 18 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by an independent clinician. Visual inspection with a mirror was performed . Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed
Marginal Staining
Time frame: From baseline to 18 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal staining. Marginal staining was evaluated by an independent clinician. Visual inspection with a mirror was performed . Scores: Alfa: No discoloration. Bravo: Discoloration without. Charlie: Discoloration with penetration in pulpal direction
Retention
Time frame: From baseline to 18 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by an independent clinician. Scores: Alfa: No loss of restorative material. Charlie: Any loss of restorative material
Seconder caries
Time frame: From baseline to 18 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by an independent clinician. Scores: Alfa: No caries present. Charlie: Caries present
Postoperative sensitivity
Time frame: From baseline to 18 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by an independent clinician. Scores: Alfa: Not present. Bravo: sensitive but diminishing in intensity. . Charlie:constant sensitivity, not diminishing in intensity
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 18 Nov 2025.
- Background: PubMed 28281590Chesterman J, Jowett A, Gallacher A, Nixon P. Bulk-fill resin-based composite restorative materials: a review. Br Dent J. 2017 Mar 10;222(5):337-344. doi: 10.1038/sj.bdj.2017.214.
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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.
Nurdan Meserret Başeren, Prof.Dr. principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VisCalor Bulk,VOCO,Germany, Admira Fusion x-tra,VOCO,Germany and Filtek One Bulk,3M,Germany in people with Class II Dental Caries, run by Hacettepe 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 6 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 18 Nov 2025. 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?
Marginal Adaptation (time frame: From baseline to 18 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06212141, which also lists 1 linked publication.
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 18 Nov 2025.