Dentin CariesNCT06771362
Evaluation of ART Restorations Using Two Different Bulk-Fill Restorative Materials in Primary Molars
A study testing ART with Bulk-Fill composite and ART with Glass Ionomer in people with Dentin Caries, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to evaluate the success of two different bulk-fill restorative materials applied to teeth restored with atraumatic treatment at 3, 6, and 12-month follow-ups. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Dentin Caries
- What is being tested?
- ART with Bulk-Fill composite and ART with Glass Ionomer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients and parents of the patients who accept to participate and sign the informed consent.
- Children between the ages of 4-9
- Healthy children without a history of serious systemic conditions necessitating chronic use of medications.
- Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS II index: code 4,5,6) affecting primary molars.
- Absence of former history of spontaneous pain from the offending tooth/teeth.
- Patients with an appropriate level of cooperation to complete treatment under clinical conditions.
- Teeth are in a restorable condition. Natural exfoliation of primary teeth to be treated should not be expected within two years.
Who cannot join
- Patients and parents of the patients who does not accept to participate and sign the informed consent
- Patients with special health care needs or any medical conditions.
- Primary molar teeth with excessive crown damage that cannot be restored.
- Primary molar teeth in which bone loss exceeds 1/3 of the roots.
- Primary molar teeth that have previously undergone root canal treatment or pulpotomy treatment.
- Presence of internal/external and root resorption in primary teeth to be treated.
- Root fracture, ankylosis or mobility in the primary teeth to be treated.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Canakkale Onsekiz Mart University
Çanakkale, Kepez, 17100
About this study
Official title: Evaluation of ART Restorations Using Two Different Bulk-Fill Restorative Materials in Primary Molars With 12-month Follow-up According to Modified USPHS and Revised FDI Criteria
The aim of this clinical study is to evaluate the success of two different bulk-fill restorative materials applied to teeth restored with atraumatic treatment at 3, 6, and 12-month follow-ups. The research seeks to address the following questions:
Which bulk-fill restorative material is more effective in terms of clinical success? How does the clinical success of bulk-fill restorations change over time (3, 6, and 12 months)? How do the two materials compare in terms of functional, aesthetic, and biological outcomes? To what extent does the cavity size of teeth with interproximal caries, restored using atraumatic treatment, influence treatment success? In this study, asymptomatic teeth with aproximal caries in children aged 4-9 will be repaired using atraumatic treatment and assessed based on the Modified USPHS (United States Public Health Service) and Revised FDI (World Dental Federation) criteria.
Read the detailed description
Atraumatic Restorative Treatment (ART) is a minimally invasive approach developed for treating dental caries. This method involves removing carious tissue to the minimum extent possible using hand instruments and restoring the cavity with a biocompatible material, such as high-viscosity glass ionomer cement (GIC). The fundamental principle of ART is to preserve the tooth's natural structure while providing a more comfortable and accessible treatment for patients. It offers a less stressful experience, particularly for children or patients with dental anxiety.
Patients between the ages of 4-9 who meet ICDAS II (International Caries Detection and Assessment System) 4-5-6 criteria and need restoration of asymptomatic primary molars with unilateral or multifaceted carious cavities will be included. Volunteers will be randomly divided into two groups, and the treatments of primary molars will be completed using two different high-viscosity glass ionamer cement (HV-GIC). The teeth in all groups will be cleaned of decay using an excavator down to the affected dentin. After the cavity is prepared, the tooth is isolated using cotton pellets.
Group 1: (RIVA Self Cure/HV, SDI, Australia) Apply a dentin conditioner (Riva Conditioner, SDI, Australia) to the prepared dentin surface for 10 seconds, then rinse thoroughly with water and gently blot dry. Ensure the tooth surface remains moist. The tooth will be restored with RIVA Self Cure (SDI, Australia) capsule form by the manufacturer's instructions, and the restoration will be covered with a sealing agent (RIVA Coat, SDI, Australia) Group 2: (STELA , SDI, Australia) STELA Primer (SDI, Australia) to the prepared cavity surface using a disposable brush applicator and leave it for 5 seconds. After drying the teeth, place the syringe into the mixer and follow the manufacturer's instructions for mixing. Apply the mixed STELA restorative material directly into the prepared cavity. The restoration is completed following the manufacturer's recommendations.
Before the procedure, demographic and dental data of the child volunteer, such as age, gender, brushing frequency, and number of teeth treated, will be recorded.
The US Public Health Service criteria (retention, anatomical form, surface roughness, secondary caries, marginal discoloration, and marginal integrity) and Modified FDI criteria will be used for clinical evaluation of restorations. The restorations will be evaluated clinically and radiologically at baseline 3., 6. and 12. months.
- Conditions
- Dentin Caries
- Being tested
- ART with Bulk-Fill composite, ART with Glass Ionomer
- Keywords
- tooth demineralization, dental caries, Stomatognathic Diseases, Atraumatic Restorative Treatment
- Medical subject headings
- Tooth Demineralization, Dental Caries, Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART with Bulk-Fill compositeProcedure or surgery
Restoration using Bulk-fill flowable self-cured composite
ART with Glass IonomerProcedure or surgery
Restoration Using High-Viscosity Glass Ionomer Cement
| Study group | Role | What they receive |
|---|---|---|
| STELA BULK-FILL RESTORATION | Experimental | Stella Bulk-Fill composite restoration after ART Receives: Procedure: ART with Bulk-Fill composite |
| GLASS IONOMER (Control) | Other | RIVA Self-Cure HV glass ionomer restoration after ART Receives: Procedure: ART with Glass Ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change form 3 months to 12 months regarding
alpha: The general contour of the restorations follows the contour bravo: the general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does
Measured: 3-month,6-month,12 month
Change from 3 months to 12 months regarding "Marginal adaptation"
alpha: Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface bravo: explorer falls into crevice drawn across the restoration/tooth interface charlie: Dentin or base is exposed along the margin
Measured: 3-month,6-month,12 month
Change from 3 months to 12 months regarding "Surface roughness"
alpha: the surface of the restoration does not have any surface defects bravo: the surface of the restoration has minimal surface defects charlie: the surface of the restoration has severe surface defects
Measured: 3-month,6-month,12 month
Change from 3 months to 12 months regarding "Marginal staining"
alpha: there is no discoloration between the restorations and tooth bravo: there is discoloration on less than half of the circumferential margin charlie: there is discoloration on more than half of the circumferential margin
Measured: 3-month,6-month,12 month
Change from 3 months to 12 months regarding "Retention"
alpha: intact bravo: chipped/loss of material charlie: complete loss of crown
Measured: 3-month,6-month,12 month
Change from 3 months to 12 months regarding "Incisal wear"
alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure
Measured: 3-month,6-month,12 month
Functional properties according to revised FDI (World Dental Federation) criteria.
Functional properties:
F2: Marginal adaptation measured by visual examination, short air drying, 250 μm probe.
F3:Proximal contact point measured by visual examination and 25/50/100 μm blades.
F4: Form and contour measured by visual examination. F5: Occlusion and occlusal wear measured by visual examination and articulation paper.
Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Measured: 3-month,6-month,12 month
Biological properties according to revised FDI criteria
Biological properties:
B1: Caries at restoration margin (CAR) measured by visual examination, short air drying, and 250 μm probe.
B2: Dental hard tissue defects at restoration margin measured by visual examination.
B3: Postoperative hypersensitivity reported by patient and pulp status tested with cold stimulus.
Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Measured: 3-month,6-month,12 month
Aesthetic properties according to revised FDI criteria
Aesthetic properties:
A1: Surface luster and surface texture measured by visual examination and short air drying.
A2: Marginal staining measured by visual examination and short air drying. A3: color match measured by visual examination. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Measured: 3-month,6-month,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start15 Jan 2025
- Primary completion15 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin CariesStudies 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
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Idil Ay Simsek, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771362
- Sponsor's protocol ID
- COMU-FD-PD-IASIMSEK-001
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In this study, the investigators are committed to sharing our findings while ensuring the privacy and confidentiality of our participants. Therefore, the investigators will only be disseminating aggregated statistical results derived from the data, rather than individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ART Restorations Using Two Different Bulk-Fill Restorative Materials in Primary Molars With 12-month Follow-up According to Modified USPHS and Revised FDI Criteria
- ClinicalTrials.gov ID
- NCT06771362
- Acronym / sponsor ID
- COMU-FD-PD-IASIMSEK-001
- Conditions
- Dentin Caries
- Keywords
- tooth demineralization, dental caries, Stomatognathic Diseases, Atraumatic Restorative Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 13 Jan 2025 (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 success of two different bulk-fill restorative materials applied to teeth restored with atraumatic treatment at 3, 6, and 12-month follow-ups. The research seeks to address the following questions:
Which bulk-fill restorative material is more effective in terms of clinical success? How does the clinical success of bulk-fill restorations change over time (3, 6, and 12 months)? How do the two materials compare in terms of functional, aesthetic, and biological outcomes? To what extent does the cavity size of teeth with interproximal caries, restored using atraumatic treatment, influence treatment success? In this study, asymptomatic teeth with aproximal caries in children aged 4-9 will be repaired using atraumatic treatment and assessed based on the Modified USPHS (United States Public Health Service) and Revised FDI (World Dental Federation) criteria.
Detailed description
Atraumatic Restorative Treatment (ART) is a minimally invasive approach developed for treating dental caries. This method involves removing carious tissue to the minimum extent possible using hand instruments and restoring the cavity with a biocompatible material, such as high-viscosity glass ionomer cement (GIC). The fundamental principle of ART is to preserve the tooth's natural structure while providing a more comfortable and accessible treatment for patients. It offers a less stressful experience, particularly for children or patients with dental anxiety.
Patients between the ages of 4-9 who meet ICDAS II (International Caries Detection and Assessment System) 4-5-6 criteria and need restoration of asymptomatic primary molars with unilateral or multifaceted carious cavities will be included. Volunteers will be randomly divided into two groups, and the treatments of primary molars will be completed using two different high-viscosity glass ionamer cement (HV-GIC). The teeth in all groups will be cleaned of decay using an excavator down to the affected dentin. After the cavity is prepared, the tooth is isolated using cotton pellets.
Group 1: (RIVA Self Cure/HV, SDI, Australia) Apply a dentin conditioner (Riva Conditioner, SDI, Australia) to the prepared dentin surface for 10 seconds, then rinse thoroughly with water and gently blot dry. Ensure the tooth surface remains moist. The tooth will be restored with RIVA Self Cure (SDI, Australia) capsule form by the manufacturer's instructions, and the restoration will be covered with a sealing agent (RIVA Coat, SDI, Australia) Group 2: (STELA , SDI, Australia) STELA Primer (SDI, Australia) to the prepared cavity surface using a disposable brush applicator and leave it for 5 seconds. After drying the teeth, place the syringe into the mixer and follow the manufacturer's instructions for mixing. Apply the mixed STELA restorative material directly into the prepared cavity. The restoration is completed following the manufacturer's recommendations.
Before the procedure, demographic and dental data of the child volunteer, such as age, gender, brushing frequency, and number of teeth treated, will be recorded.
The US Public Health Service criteria (retention, anatomical form, surface roughness, secondary caries, marginal discoloration, and marginal integrity) and Modified FDI criteria will be used for clinical evaluation of restorations. The restorations will be evaluated clinically and radiologically at baseline 3., 6. and 12. months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STELA BULK-FILL RESTORATION | Experimental | Procedure: ART with Bulk-Fill compositeStella Bulk-Fill composite restoration after ART |
| GLASS IONOMER (Control) | Other | Procedure: ART with Glass IonomerRIVA Self-Cure HV glass ionomer restoration after ART |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients and parents of the patients who accept to participate and sign the informed consent.
- Children between the ages of 4-9
- Healthy children without a history of serious systemic conditions necessitating chronic use of medications.
- Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS II index: code 4,5,6) affecting primary molars.
- Absence of former history of spontaneous pain from the offending tooth/teeth.
Key exclusion criteria (7 listed)
- Patients and parents of the patients who does not accept to participate and sign the informed consent
- Patients with special health care needs or any medical conditions.
- Primary molar teeth with excessive crown damage that cannot be restored.
- Primary molar teeth in which bone loss exceeds 1/3 of the roots.
- Primary molar teeth that have previously undergone root canal treatment or pulpotomy treatment.
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 |
|---|---|---|
| ART with Bulk-Fill compositeRestoration using Bulk-fill flowable self-cured composite | Procedure or surgery | STELA BULK-FILL RESTORATION |
| ART with Glass IonomerRestoration Using High-Viscosity Glass Ionomer Cement | Procedure or surgery | GLASS IONOMER (Control) |
Primary outcome
Change form 3 months to 12 months regarding
Time frame: 3-month,6-month,12 month
alpha: The general contour of the restorations follows the contour bravo: the general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does
Change from 3 months to 12 months regarding "Marginal adaptation"
Time frame: 3-month,6-month,12 month
alpha: Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface bravo: explorer falls into crevice drawn across the restoration/tooth interface charlie: Dentin or base is exposed along the margin
Change from 3 months to 12 months regarding "Surface roughness"
Time frame: 3-month,6-month,12 month
alpha: the surface of the restoration does not have any surface defects bravo: the surface of the restoration has minimal surface defects charlie: the surface of the restoration has severe surface defects
Change from 3 months to 12 months regarding "Marginal staining"
Time frame: 3-month,6-month,12 month
alpha: there is no discoloration between the restorations and tooth bravo: there is discoloration on less than half of the circumferential margin charlie: there is discoloration on more than half of the circumferential margin
Change from 3 months to 12 months regarding "Retention"
Time frame: 3-month,6-month,12 month
alpha: intact bravo: chipped/loss of material charlie: complete loss of crown
Change from 3 months to 12 months regarding "Incisal wear"
Time frame: 3-month,6-month,12 month
alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure
Functional properties according to revised FDI (World Dental Federation) criteria.
Time frame: 3-month,6-month,12 month
Functional properties: F2: Marginal adaptation measured by visual examination, short air drying, 250 μm probe. F3:Proximal contact point measured by visual examination and 25/50/100 μm blades. F4: Form and contour measured by visual examination. F5: Occlusion and occlusal wear measured by visual examination and articulation paper. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Biological properties according to revised FDI criteria
Time frame: 3-month,6-month,12 month
Biological properties: B1: Caries at restoration margin (CAR) measured by visual examination, short air drying, and 250 μm probe. B2: Dental hard tissue defects at restoration margin measured by visual examination. B3: Postoperative hypersensitivity reported by patient and pulp status tested with cold stimulus. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Aesthetic properties according to revised FDI criteria
Time frame: 3-month,6-month,12 month
Aesthetic properties: A1: Surface luster and surface texture measured by visual examination and short air drying. A2: Marginal staining measured by visual examination and short air drying. A3: color match measured by visual examination. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No. In this study, the investigators are committed to sharing our findings while ensuring the privacy and confidentiality of our participants. Therefore, the investigators will only be disseminating aggregated statistical results derived from the data, rather than individual participant data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ART with Bulk-Fill composite and ART with Glass Ionomer in people with Dentin Caries, run by Çanakkale Onsekiz Mart 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 26 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change form 3 months to 12 months regarding (time frame: 3-month,6-month,12 month). The study lists 9 primary outcomes in all. 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 26 Jan 2026.