Decayed Primary MolarsNCT07868016
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
A study testing Stela Capsule Bulk Fill Flowable Self-Cure Restorative and Filtek One Bulk Fill Restorative in people with Decayed Primary Molars and Decayed Tooth, run by Burak Carıkcıoglu at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the clinical performance of chemically-cured and light-cured bulk-fill composite materials used for Class II restorations in children aged 4 to 9 years with primary second molars. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Decayed Primary Molars, Decayed Tooth, Dentin Caries
- What is being tested?
- Stela Capsule Bulk Fill Flowable Self-Cure Restorative and Filtek One Bulk Fill Restorative
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2026to 30 Apr 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cooperative pediatric patients aged between 4 and 9 years.
- Presence of bilateral primary second molars with Class II dentin caries requiring restoration.
- Teeth with positive response to vitality tests (where applicable) and no clinical signs or symptoms of irreversible pulpitis, periapical pathology, or spontaneous pain.
- Teeth restorable with direct restorative techniques.
- Parents or legal guardians providing signed informed consent.
Who cannot join
- Patients with systemic diseases, bleeding disorders, or physical/mental disabilities that prevent cooperation during dental treatment.
- Teeth with excessive loss of tooth structure that cannot be restored with a direct restoration or requiring crown coverage.
- Teeth with clinical or radiographic signs of pulp exposure, pulp involvement, internal/external resorption, or periapical/furcation involvement.
- Teeth with poor oral hygiene or high caries risk where isolation is compromised.
- Known allergy or hypersensitivity to the components of the tested materials (e.g., resin composites, primers, adhesives).
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
Çanakkale Onsekiz Mart University
Çanakkale, Merkez
Burak Çarıkçıoğlu, +905054956091, carikcioglub@gmail.com
Burak Çarıkçıoğlu
About this study
Official title: Evaluation of Clinical Success and Survival of Different Restorative Materials in Primary Teeth: A Randomized Controlled Split-Mouth Clinical Trial
The goal of this clinical trial is to compare the clinical performance of chemically-cured and light-cured bulk-fill composite materials used for Class II restorations in children aged 4 to 9 years with primary second molars. The main questions it aims to answer are:
What are the clinical success rates of the restorations at 12 months based on modified FDI criteria?
Read more
How do the two materials compare regarding application times, clinician ease of use, and patient satisfaction?
Researchers will compare the chemically-cured bulk-fill composite (Stela Capsule) to the light-cured bulk-fill composite (Filtek One) using a split-mouth design to see which material provides better long-term clinical performance and survival rates.
Participants will:
Receive two different bulk-fill composite restorations in matched primary second molars within the same dental arch
Visit the clinic for routine checkups and evaluations at 1 week, 3 months, 6 months, 12 months, 24 months, and 36 months
Read the detailed description
This study is designed as a prospective, single-center, double-blind, randomized controlled clinical trial with a split-mouth design. A total of 70 cooperative pediatric patients aged 4 to 9 years having bilateral primary second molars with Class II dentin caries will be enrolled. Randomization will be performed at the patient level using a permuted block randomization method with sealed envelopes to assign treatments to contralateral homologous tooth pairs. Two restorative materials will be evaluated: a chemically-cured bulk-fill flowable composite (Stela Capsule, SDI Limited) applied with Stela Primer, and a light-cured high-viscosity bulk-fill composite (Filtek One Bulk Fill Restorative, 3M Solventum) applied with Scotchbond Universal Adhesive. All restorations will be placed by a single operator following strict isolation and manufacturer instructions. Clinical evaluations will be conducted by two independent, calibrated, and blinded observers at 1 week, 3 months, 6 months, 12 months, 24 months, and 36 months using modified FDI criteria. Secondary parameters, including restoration application time, clinician ease of use (evaluated via Visual Analog Scale), patient satisfaction (measured using the Smiles Scale at 7 days), and oral hygiene indexes (Silness-Loe plaque index and gingival index), will also be recorded. Statistical analyses will include McNemar's test, Kaplan-Meier survival analysis, Generalized Estimating Equations (GEE), and mixed-effects logistic regression models.
- Conditions
- Decayed Primary Molars, Decayed Tooth, Dentin Caries
- Being tested
- Stela Capsule Bulk Fill Flowable Self-Cure Restorative, Filtek One Bulk Fill Restorative
- Keywords
- dental caries, pediatric dentistry, primary teeth, deciduous teeth, primary molars, Class II Restorations, Bulk-Fill Composite, Resin Composite, Dental Restoration, Chemically-Cured Composite, Light-Cured Composite
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stela Capsule Bulk Fill Flowable Self-Cure RestorativeDevice
Direct restorative application of a chemically-cured flowable bulk-fill composite material following the application of Stela Primer to cavity surfaces in primary second molar Class II cavities
Filtek One Bulk Fill RestorativeDevice
Direct restorative application of a light-cured high-viscosity bulk-fill composite material following the application of Scotchbond Universal Adhesive, polymerized with an LED light source for 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Test Group - Stela Capsule | Experimental | Direct restorative application of a chemically-cured flowable bulk-fill composite material (Stela Capsule) following the application of Stela Primer to the cavity surfaces in primary second molar Class II cavities, set without a light source. Receives: Device: Stela Capsule Bulk Fill Flowable Self-Cure Restorative |
| Control Group - Filtek One | Active comparator | Direct restorative application of a light-cured high-viscosity bulk-fill composite material (Filtek One Bulk Fill Restorative) following the application of Scotchbond Universal Adhesive, polymerized with an LED light source ($1200~mW/cm^{2}$) for 20 seconds. Receives: Device: Filtek One Bulk Fill Restorative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Rate Based on Modified FDI Criteria
The clinical performance of the restorations will be evaluated using the modified World Dental Federation (FDI) criteria, which assess aesthetic, functional, and biological properties on a scale of 1 to 5. Higher scores indicate poorer clinical performance. Each restoration will be classified as either clinically acceptable (FDI scores 1-3) or clinically unacceptable (FDI scores 4-5). The overall clinical success rate will be calculated as the percentage of clinically acceptable restorations.
Measured: At 12 months post-operative
Secondary outcomes (6)
Long-Term Restoration Survival Rate a
Assessment of overall restoration survival and retention rates over a 36-month period
Measured: At 1 week, 3 months, 6 months, 12 months, 24 months, and 36 months
Restoration Application Time
Recording the total placement time in seconds during the restorative procedure.
Measured: Day 1 (during the restorative procedure)
Clinician Ease of Use
Evaluating the clinician's ease of use using a Visual Analog Scale (VAS) (VAS, range 0 to 100 mm, where higher scores indicate greater ease of use).
Measured: Day 1 (during the restorative procedure)
Patient Satisfaction
Evaluation of the child patient's satisfaction regarding the restoration procedure measured using the Smiles Scale. (range 1 to 5, where higher scores indicate better patient satisfaction)
Measured: At 7 days post-operative
Silness-Lõe Plaque Index Score
Assessment of oral hygiene levels using the Silness-Lõe plaque index. (range 0 to 3, where higher scores indicate poorer oral hygiene)
Measured: At baseline, 6 months, 12 months, 24 months, and 36 months
Gingival Index Score
Assessment of gingival health status using the gingival index. (range 0 to 3, where higher scores indicate severe inflammation and poorer gingival health)
Measured: At baseline, 6 months, 12 months, 24 months, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Decayed Primary MolarsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burak Carıkcıoglu
- Sponsor type
- University, hospital or other
- Collaborators
- Çanakkale Onsekiz Mart University
- Responsible party
- Sponsor-investigator, Burak Carıkcıoglu, Çanakkale Onsekiz Mart University
- Investigators
- Burak Çarıkçıoğlu, Principal investigator, Çanakkale Onsekiz Mart UniversitySıla Erdal, Principal investigator, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868016
- Sponsor's protocol ID
- COMU-PEDO-2026-01
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Loguercio AD, Carpio-Salvatierra B, Naupari-Villasante R, Armas-Vega A, Cavagnaro S, Leon A, Aliaga-Galvez R, Soares CJ, Gutierrez MF. Clinical evaluation of a new chemically-cured bulk-fill composite in posterior restorations: 18-Month multicenter double-blind randomized clinical trial. J Dent. 2025 Nov;162:106031. doi: 10.1016/j.jdent.2025.106031. Epub 2025 Aug 14.
PubMed 40818514Loguercio AD, Carpio-Salvatierra B, Naupari-Villasante R, Wendlinger M, Armas-Vega A, Cavagnaro S, Leon A, Aliaga-Galvez R, Gutierrez MF. Clinical evaluation of a new chemically-cured bulk-fill composite in posterior restorations: 6-month multicenter double-blind randomized clinical trial. J Dent. 2024 Oct;149:105246. doi: 10.1016/j.jdent.2024.105246. Epub 2024 Jul 25.
PubMed 39025426
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Success and Survival of Different Restorative Materials in Primary Teeth: A Randomized Controlled Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07868016
- Acronym / sponsor ID
- COMU-PEDO-2026-01
- Conditions
- Decayed Primary Molars, Decayed Tooth, Dentin Caries
- Keywords
- dental caries, pediatric dentistry, primary teeth, deciduous teeth, primary molars, Class II Restorations, Bulk-Fill Composite, Resin Composite
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Burak CarıkcıogluUniversity, hospital or other
- Collaborators
- Çanakkale Onsekiz Mart University
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Oct 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 goal of this clinical trial is to compare the clinical performance of chemically-cured and light-cured bulk-fill composite materials used for Class II restorations in children aged 4 to 9 years with primary second molars. The main questions it aims to answer are:
What are the clinical success rates of the restorations at 12 months based on modified FDI criteria?
How do the two materials compare regarding application times, clinician ease of use, and patient satisfaction?
Researchers will compare the chemically-cured bulk-fill composite (Stela Capsule) to the light-cured bulk-fill composite (Filtek One) using a split-mouth design to see which material provides better long-term clinical performance and survival rates.
Participants will:
Receive two different bulk-fill composite restorations in matched primary second molars within the same dental arch
Visit the clinic for routine checkups and evaluations at 1 week, 3 months, 6 months, 12 months, 24 months, and 36 months
Detailed description
This study is designed as a prospective, single-center, double-blind, randomized controlled clinical trial with a split-mouth design. A total of 70 cooperative pediatric patients aged 4 to 9 years having bilateral primary second molars with Class II dentin caries will be enrolled. Randomization will be performed at the patient level using a permuted block randomization method with sealed envelopes to assign treatments to contralateral homologous tooth pairs. Two restorative materials will be evaluated: a chemically-cured bulk-fill flowable composite (Stela Capsule, SDI Limited) applied with Stela Primer, and a light-cured high-viscosity bulk-fill composite (Filtek One Bulk Fill Restorative, 3M Solventum) applied with Scotchbond Universal Adhesive. All restorations will be placed by a single operator following strict isolation and manufacturer instructions. Clinical evaluations will be conducted by two independent, calibrated, and blinded observers at 1 week, 3 months, 6 months, 12 months, 24 months, and 36 months using modified FDI criteria. Secondary parameters, including restoration application time, clinician ease of use (evaluated via Visual Analog Scale), patient satisfaction (measured using the Smiles Scale at 7 days), and oral hygiene indexes (Silness-Loe plaque index and gingival index), will also be recorded. Statistical analyses will include McNemar's test, Kaplan-Meier survival analysis, Generalized Estimating Equations (GEE), and mixed-effects logistic regression models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group - Stela Capsule | Experimental | Device: Stela Capsule Bulk Fill Flowable Self-Cure RestorativeDirect restorative application of a chemically-cured flowable bulk-fill composite material (Stela Capsule) following the application of Stela Primer to the cavity surfaces in primary second molar Class II cavities, set without a light source. |
| Control Group - Filtek One | Active comparator | Device: Filtek One Bulk Fill RestorativeDirect restorative application of a light-cured high-viscosity bulk-fill composite material (Filtek One Bulk Fill Restorative) following the application of Scotchbond Universal Adhesive, polymerized with an LED light source ($1200~mW/cm^{2}$) for 20 seconds. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Cooperative pediatric patients aged between 4 and 9 years.
- Presence of bilateral primary second molars with Class II dentin caries requiring restoration.
- Teeth with positive response to vitality tests (where applicable) and no clinical signs or symptoms of irreversible pulpitis, periapical pathology, or spontaneous pain.
- Teeth restorable with direct restorative techniques.
- Parents or legal guardians providing signed informed consent.
Key exclusion criteria (5 listed)
- Patients with systemic diseases, bleeding disorders, or physical/mental disabilities that prevent cooperation during dental treatment.
- Teeth with excessive loss of tooth structure that cannot be restored with a direct restoration or requiring crown coverage.
- Teeth with clinical or radiographic signs of pulp exposure, pulp involvement, internal/external resorption, or periapical/furcation involvement.
- Teeth with poor oral hygiene or high caries risk where isolation is compromised.
- Known allergy or hypersensitivity to the components of the tested materials (e.g., resin composites, primers, adhesives).
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 |
|---|---|---|
| Stela Capsule Bulk Fill Flowable Self-Cure RestorativeDirect restorative application of a chemically-cured flowable bulk-fill composite material following the application of Stela Primer to cavity surfaces in primary second molar Class II cavities | Device | Test Group - Stela Capsule |
| Filtek One Bulk Fill RestorativeDirect restorative application of a light-cured high-viscosity bulk-fill composite material following the application of Scotchbond Universal Adhesive, polymerized with an LED light source for 20 seconds. | Device | Control Group - Filtek One |
Primary outcome
Clinical Success Rate Based on Modified FDI Criteria
Time frame: At 12 months post-operative
The clinical performance of the restorations will be evaluated using the modified World Dental Federation (FDI) criteria, which assess aesthetic, functional, and biological properties on a scale of 1 to 5. Higher scores indicate poorer clinical performance. Each restoration will be classified as either clinically acceptable (FDI scores 1-3) or clinically unacceptable (FDI scores 4-5). The overall clinical success rate will be calculated as the percentage of clinically acceptable restorations.
6 secondary outcomes
Long-Term Restoration Survival Rate a
Time frame: At 1 week, 3 months, 6 months, 12 months, 24 months, and 36 months
Restoration Application Time
Time frame: Day 1 (during the restorative procedure)
Clinician Ease of Use
Time frame: Day 1 (during the restorative procedure)
Patient Satisfaction
Time frame: At 7 days post-operative
Silness-Lõe Plaque Index Score
Time frame: At baseline, 6 months, 12 months, 24 months, and 36 months
Gingival Index Score
Time frame: At baseline, 6 months, 12 months, 24 months, and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 40818514Loguercio AD, Carpio-Salvatierra B, Naupari-Villasante R, Armas-Vega A, Cavagnaro S, Leon A, Aliaga-Galvez R, Soares CJ, Gutierrez MF. Clinical evaluation of a new chemically-cured bulk-fill composite in posterior restorations: 18-Month multicenter double-blind randomized clinical trial. J Dent. 2025 Nov;162:106031. doi: 10.1016/j.jdent.2025.106031. Epub 2025 Aug 14.
- Background: PubMed 39025426Loguercio AD, Carpio-Salvatierra B, Naupari-Villasante R, Wendlinger M, Armas-Vega A, Cavagnaro S, Leon A, Aliaga-Galvez R, Gutierrez MF. Clinical evaluation of a new chemically-cured bulk-fill composite in posterior restorations: 6-month multicenter double-blind randomized clinical trial. J Dent. 2024 Oct;149:105246. doi: 10.1016/j.jdent.2024.105246. Epub 2024 Jul 25.
- Individual participant dataSharing planned: Undecided
Related trials for Decayed Primary Molars
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
Not yet recruiting
Clinical and Radiographic Evaluation of Injectable Composite Versus Packable Composite in Restoring of Primary Molars
Dental Caries in Children
Active, not recruiting
Clinical Outcomes and Satisfaction of Stainless Steel vs Bioflx Crowns in Primary Molars
Severely Decayed Primary Molars Requiring Full-Coverage Crowns
Not yet recruiting
Evaluation of Cytokines Level as an Indicator of Pulp Inflammation and Its Relation to the Success Rates of Pulpotomy in Primary Molars Affected With Proximal Versus Occlusal Decay
Pulpitis - Reversible, Occlusal Caries
Not yet recruiting
Clinical and Radiographic Success of Nusmile Bioflex Versus Stainless-Steel Crowns in Restoring Decayed Primary Molars with Modified Hall Technique
Restoration of Primary Molars with Bioflex Crowns
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.
Burak Çarıkçıoğlu principal investigator
Çanakkale Onsekiz Mart University
Sıla Erdal principal investigator
Çanakkale Onsekiz Mart 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 Stela Capsule Bulk Fill Flowable Self-Cure Restorative and Filtek One Bulk Fill Restorative in people with Decayed Primary Molars and Decayed Tooth, run by Burak Carıkcıoglu 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 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 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 Burak Çarıkçıoğlu (+905054956091, carikcioglub@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success Rate Based on Modified FDI Criteria (time frame: At 12 months post-operative). 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 NCT07868016, which also lists 2 linked publications.
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 9 Oct 2026.