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Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars

ConditionsDecayed Primary MolarsDecayed ToothDentin Caries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-9
SponsorBurak Carıkcıoglu

About this 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?

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stela Capsule Bulk Fill Flowable Self-Cure Restorative

    Device

    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 Restorative

    Device

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Test Group - Stela CapsuleExperimental treatment 1 intervention
Group B: Control Group - Filtek OneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Restoration Application Time

Recording the total placement time in seconds during the restorative procedure.

Time frame
Day 1 (during the restorative procedure)
3

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)
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Burak Carıkcıoglu

Lead sponsor

Çanakkale Onsekiz Mart University

Sponsor institution

Çanakkale Onsekiz Mart University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: