An interventional study of Stela Capsule Bulk Fill Flowable Self-Cure Restorative and Filtek One Bulk Fill Restorative in Decayed Primary Molars, Decayed Tooth and Dentin Caries, sponsored by Burak Carıkcıoglu. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 4 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Burak Carıkcıoglu · Not applicable, Interventional, and Treatment
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
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.
1,137 studies on the registry are indexed under Dental Caries; 201 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 936 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →This is the only study on the registry with Burak Carıkcıoglu as lead sponsor.
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Exclusion Criteria:
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.
Device: Stela Capsule Bulk Fill Flowable Self-Cure Restorative
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.
Device: Filtek One Bulk Fill Restorative
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
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.
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.
Time frame: At 12 months post-operative
Long-Term Restoration Survival Rate a
Assessment of overall restoration survival and retention rates over a 36-month period
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At baseline, 6 months, 12 months, 24 months, and 36 months
Plan to share: Undecided
Start is estimated for Oct 2026; primary completion for Apr 2027, 6 months later.
Of 458 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 6 months is below that.
Counting every sponsor, half of 486 studies reached it within 15 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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