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

NCT07868016 | Not Yet Recruiting

• 1 other identifier: COMU-PEDO-2026-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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

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; Dental Restoration; Chemically-Cured Composite; Light-Cured Composite

Outcome Measures

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.

  At 12 months post-operative

Secondary Outcomes (6)

• Long-Term Restoration Survival Rate a

  At 1 week, 3 months, 6 months, 12 months, 24 months, and 36 months

• Restoration Application Time

  Day 1 (during the restorative procedure)

• Clinician Ease of Use

  Day 1 (during the restorative procedure)

• Patient Satisfaction

  At 7 days post-operative

• Silness-Lõe Plaque Index Score

  At baseline, 6 months, 12 months, 24 months, and 36 months

Study Arms (2)

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.

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.

Device: Filtek One Bulk Fill Restorative

Interventions

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

Test Group - Stela Capsule

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.

Control Group - Filtek One

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Burak Carıkcıoglu: lead
• Çanakkale Onsekiz Mart University: collaborator

Study Sites (1)

Çanakkale Onsekiz Mart University

Çanakkale, Merkez, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 40818514 BACKGROUND

• Loguercio 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.

  PMID: 39025426 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Burak Çarıkçıoğlu

  Çanakkale Onsekiz Mart University

  PRINCIPAL INVESTIGATOR

• Sıla Erdal

  Çanakkale Onsekiz Mart University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burak Çarıkçıoğlu

CONTACT

+905054956091; carikcioglub@gmail.com

Sıla Erdal

CONTACT

+905455840010; silaerdal13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Department of Pedodontics

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

TU (1)