Composite ResinsNCT07518537
Bulk-Fill Composite Restorations: Clinical Evaluation
A study testing Thermoviscous bulk-fill composite restoration, Sonic-activated bulk-fill composite restoration and Flowable bulk-fill composite restoration in people with Composite Resins and Dental Caries Class II, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical study aims to evaluate the clinical performance of five different bulk-fill composite materials representing distinct technological approaches according to the World Dental Federation (FDI) criteria. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Composite Resins, Dental Caries Class II
- What is being tested?
- Thermoviscous bulk-fill composite restoration, Sonic-activated bulk-fill composite restoration and Flowable bulk-fill composite restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2026to 20 Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and older
- Patients in good general health (systemically healthy)
- Patients with good oral hygiene
- Patients with good periodontal health
- Presence of at least one posterior tooth requiring restoration
- Teeth must be vital and asymptomatic
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- Teeth must have proximal contact with adjacent teeth on both mesial and distal surfaces
- Teeth must be in functional occlusion with an antagonist tooth
- Presence of at least one carious lesion not extending deeper than two-thirds of dentin, with a clinical ICDAS code ≤ 3
- Absence of periapical pathology confirmed by radiographic evaluation
- Patients who voluntarily agree to participate and provide written informed consent
Who cannot join
- Presence of any systemic disease
- Poor oral hygiene
- Presence of active or severe periodontal disease
- Teeth with previous restorations or endodontic treatment
- Non-vital (devitalized) or symptomatic teeth
- Patients who are pregnant or breastfeeding
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- Patients undergoing active orthodontic treatment
- Presence of parafunctional habits (e.g., bruxism) or xerostomia
- Current tobacco use or history of heavy smoking
- Patients unwilling or unable to attend follow-up visits
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
Atatürk University Faculty of Dentistry
Erzurum, 25240
Cemile Arslan, Research Asisistant, +905396845019, cemilegonul15@gmail.com
Cemile Arslan, Research Assistant
About this study
Official title: Clinical Evaluation of Restorations Performed With Bulk-Fill Composites of Different Technologies According to FDI Criteria: A Randomized Controlled Clinical Follow-Up Study
This randomized controlled clinical study aims to evaluate the clinical performance of five different bulk-fill composite materials representing distinct technological approaches according to the World Dental Federation (FDI) criteria. The materials include a thermoviscous bulk-fill composite applied with preheating, a sonic-activated bulk-fill composite, a flowable bulk-fill composite, an ORMOCER-based bulk-fill composite, and a conventional bulk-fill composite. Restorations will be clinically assessed at baseline, 1 month, 6 months, and 12 months for esthetic, functional, and biological outcomes.
Read the detailed description
This randomized controlled clinical follow-up study is planned to evaluate the clinical performance of posterior restorations performed with five different bulk-fill composite materials representing distinct technological approaches. The materials to be investigated include a thermoviscous bulk-fill composite applied with preheating, a sonic-activated bulk-fill composite, a flowable bulk-fill composite, an ORMOCER based bulk-fill composite, and a conventional bulk-fill composite.
The study will be conducted in patients requiring direct posterior restorations. After cavity preparation and restorative procedures performed according to the manufacturers' instructions, restorations will be placed using the assigned bulk-fill composite material. Clinical evaluations will be performed according to the World Dental Federation (FDI) criteria. The restorations will be assessed in terms of esthetic, functional, and biological properties.
Follow-up examinations will be carried out at baseline, 1 month, 6 months, and 12 months. The primary aim of the study is to compare the short-term clinical performance of bulk-fill composite materials with different technological characteristics. The findings are expected to provide clinically relevant information regarding the effectiveness and reliability of these restorative materials in posterior teeth.
- Conditions
- Composite Resins, Dental Caries Class II
- Being tested
- Thermoviscous bulk-fill composite restoration, Sonic-activated bulk-fill composite restoration, Flowable bulk-fill composite restoration, ORMOCER-based bulk-fill composite restoration, Conventional bulk-fill composite restoration
- Keywords
- FDI Criteria, Clinical Evaluation, Bulkfill, Composite Resins, Thermoviscous, Sonicfill, Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermoviscous bulk-fill composite restorationOther
Posterior restorations in this group will be performed using a thermoviscous bulk-fill composite material applied after preheating according to the manufacturer's instructions.
Sonic-activated bulk-fill composite restorationOther
Posterior restorations in this group will be performed using a sonic-activated bulk-fill composite material with reduced viscosity during placement, according to the manufacturer's instructions.
Flowable bulk-fill composite restorationOther
Posterior restorations in this group will be performed using a flowable bulk-fill composite material according to the manufacturer's instructions.
ORMOCER-based bulk-fill composite restorationOther
Posterior restorations in this group will be performed using an ORMOCER-based bulk-fill composite material according to the manufacturer's instructions.
Conventional bulk-fill composite restorationOther
Posterior restorations in this group will be performed using a conventional bulk-fill composite material according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Viscolor | Experimental | Participants assigned to this group will receive posterior restorations using a thermoviscous bulk-fill composite material applied after preheating according to the manufacturer's instructions. Receives: Other: Thermoviscous bulk-fill composite restoration |
| SonicFill | Experimental | Participants assigned to this group will receive posterior restorations using a sonic-activated bulk-fill composite material with reduced viscosity during placement, according to the manufacturer's instructions. Receives: Other: Sonic-activated bulk-fill composite restoration |
| Estelite Bulk Flow | Experimental | Participants assigned to this group will receive posterior restorations using a flowable bulk-fill composite material applied according to the manufacturer's instructions. Receives: Other: Flowable bulk-fill composite restoration |
| Admira Fusion Xtra | Experimental | Participants assigned to this group will receive posterior restorations using an ORMOCER-based bulk-fill composite material applied according to the manufacturer's instructions. Receives: Other: ORMOCER-based bulk-fill composite restoration |
| Filltek Bulkfill Composite | Experimental | Participants assigned to this group will receive posterior restorations using a conventional bulk-fill composite material applied according to the manufacturer's instructions. Receives: Other: Conventional bulk-fill composite restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance according to FDI criteria
The clinical performance of posterior restorations will be evaluated according to World Dental Federation (FDI) criteria, including esthetic, functional, and biological properties.
Measured: Baseline (1 month), 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 posted8 Apr 2026
- Study start20 May 2026 (estimated)
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Composite ResinsStudies of the same condition, open and under way.
- 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
- This study will use a randomized parallel-group design. Participants will be randomly assigned to one of the study groups, and all eligible posterior restorations within the same participant will be restored using the same assigned bulk-fill composite material. The number of restorations may vary among participants according to individual treatment needs.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- Atatürk University Scientific Research Projects Coordination Unit
- Responsible party
- Principal investigator, Cemile Arslan, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518537
- Sponsor's protocol ID
- TDH-2026-17149
- Other IDs
- TDH-2026-17149
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 8 Apr 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Restorations Performed With Bulk-Fill Composites of Different Technologies According to FDI Criteria: A Randomized Controlled Clinical Follow-Up Study
- ClinicalTrials.gov ID
- NCT07518537
- Acronym / sponsor ID
- TDH-2026-17149
- Conditions
- Composite Resins, Dental Caries Class II
- Keywords
- FDI Criteria, Clinical Evaluation, Bulkfill, Composite Resins, Thermoviscous, Sonicfill, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- Atatürk University Scientific Research Projects Coordination Unit
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 8 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 randomized controlled clinical study aims to evaluate the clinical performance of five different bulk-fill composite materials representing distinct technological approaches according to the World Dental Federation (FDI) criteria. The materials include a thermoviscous bulk-fill composite applied with preheating, a sonic-activated bulk-fill composite, a flowable bulk-fill composite, an ORMOCER-based bulk-fill composite, and a conventional bulk-fill composite. Restorations will be clinically assessed at baseline, 1 month, 6 months, and 12 months for esthetic, functional, and biological outcomes.
Detailed description
This randomized controlled clinical follow-up study is planned to evaluate the clinical performance of posterior restorations performed with five different bulk-fill composite materials representing distinct technological approaches. The materials to be investigated include a thermoviscous bulk-fill composite applied with preheating, a sonic-activated bulk-fill composite, a flowable bulk-fill composite, an ORMOCER based bulk-fill composite, and a conventional bulk-fill composite.
The study will be conducted in patients requiring direct posterior restorations. After cavity preparation and restorative procedures performed according to the manufacturers' instructions, restorations will be placed using the assigned bulk-fill composite material. Clinical evaluations will be performed according to the World Dental Federation (FDI) criteria. The restorations will be assessed in terms of esthetic, functional, and biological properties.
Follow-up examinations will be carried out at baseline, 1 month, 6 months, and 12 months. The primary aim of the study is to compare the short-term clinical performance of bulk-fill composite materials with different technological characteristics. The findings are expected to provide clinically relevant information regarding the effectiveness and reliability of these restorative materials in posterior teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- This study will use a randomized parallel-group design. Participants will be randomly assigned to one of the study groups, and all eligible posterior restorations within the same participant will be restored using the same assigned bulk-fill composite material. The number of restorations may vary among participants according to individual treatment needs.
| Arm | Type | Receives |
|---|---|---|
| Viscolor | Experimental | Other: Thermoviscous bulk-fill composite restorationParticipants assigned to this group will receive posterior restorations using a thermoviscous bulk-fill composite material applied after preheating according to the manufacturer's instructions. |
| SonicFill | Experimental | Other: Sonic-activated bulk-fill composite restorationParticipants assigned to this group will receive posterior restorations using a sonic-activated bulk-fill composite material with reduced viscosity during placement, according to the manufacturer's instructions. |
| Estelite Bulk Flow | Experimental | Other: Flowable bulk-fill composite restorationParticipants assigned to this group will receive posterior restorations using a flowable bulk-fill composite material applied according to the manufacturer's instructions. |
| Admira Fusion Xtra | Experimental | Other: ORMOCER-based bulk-fill composite restorationParticipants assigned to this group will receive posterior restorations using an ORMOCER-based bulk-fill composite material applied according to the manufacturer's instructions. |
| Filltek Bulkfill Composite | Experimental | Other: Conventional bulk-fill composite restorationParticipants assigned to this group will receive posterior restorations using a conventional bulk-fill composite material applied according to the manufacturer's instructions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients aged 18 years and older
- Patients in good general health (systemically healthy)
- Patients with good oral hygiene
- Patients with good periodontal health
- Presence of at least one posterior tooth requiring restoration
Key exclusion criteria (10 listed)
- Presence of any systemic disease
- Poor oral hygiene
- Presence of active or severe periodontal disease
- Teeth with previous restorations or endodontic treatment
- Non-vital (devitalized) or symptomatic teeth
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 |
|---|---|---|
| Thermoviscous bulk-fill composite restorationPosterior restorations in this group will be performed using a thermoviscous bulk-fill composite material applied after preheating according to the manufacturer's instructions. | Other | Viscolor |
| Sonic-activated bulk-fill composite restorationPosterior restorations in this group will be performed using a sonic-activated bulk-fill composite material with reduced viscosity during placement, according to the manufacturer's instructions. | Other | SonicFill |
| Flowable bulk-fill composite restorationPosterior restorations in this group will be performed using a flowable bulk-fill composite material according to the manufacturer's instructions. | Other | Estelite Bulk Flow |
| ORMOCER-based bulk-fill composite restorationPosterior restorations in this group will be performed using an ORMOCER-based bulk-fill composite material according to the manufacturer's instructions. | Other | Admira Fusion Xtra |
| Conventional bulk-fill composite restorationPosterior restorations in this group will be performed using a conventional bulk-fill composite material according to the manufacturer's instructions. | Other | Filltek Bulkfill Composite |
Primary outcome
Clinical performance according to FDI criteria
Time frame: Baseline (1 month), 6 months, and 12 months
The clinical performance of posterior restorations will be evaluated according to World Dental Federation (FDI) criteria, including esthetic, functional, and biological properties.
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 8 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermoviscous bulk-fill composite restoration, Sonic-activated bulk-fill composite restoration and Flowable bulk-fill composite restoration in people with Composite Resins and Dental Caries Class II, run by Ataturk 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 11 inclusion and 10 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: opening soon, as of the sponsor's last update on 8 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?
Contact Cemile Arslan, Research Assistant (+905396845019, cemilegonul15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance according to FDI criteria (time frame: Baseline (1 month), 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 8 Apr 2026.