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Clinical Trials in Turkey / NCT07518537
Starting soon Not applicable

Bulk-Fill Composite Restorations: Clinical Evaluation

NCT07518537 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ataturk University
Phase
Not applicable
Started
2026-05-20
Last updated
2026-04-08

Condition(s) studied

Composite ResinsDental Caries Class II

Investigational drug(s) / intervention(s)

Thermoviscous bulk-fill composite restorationSonic-activated bulk-fill composite restorationFlowable bulk-fill composite restorationORMOCER-based bulk-fill composite restorationConventional bulk-fill composite restoration

Thermoviscous bulk-fill composite restoration: Posterior restorations in this group will be performed using a thermoviscous bulk-fill composite material applied after preheating according to the manufacturer's instructions.

Sonic-activated bulk-fill composite restoration: Posterior restorations in this group will be performed using a sonic-activated bulk-fill composite material with reduced viscosity during placement, according to the manufacturer's instructions.

Flowable bulk-fill composite restoration: Posterior restorations in this group will be performed using a flowable bulk-fill composite material according to the manufacturer's instructions.

ORMOCER-based bulk-fill composite restoration: Posterior restorations in this group will be performed using an ORMOCER-based bulk-fill composite material according to the manufacturer's instructions.

Conventional bulk-fill composite restoration: Posterior restorations in this group will be performed using a conventional bulk-fill composite material according to the manufacturer's instructions.

Study summary

This randomized controlled clinical study aims to evaluate the clinical performance of five different bulk-fill composite materials representing distinct technological approaches according to the World Dental Federation (FDI) criteria. The materials include a thermoviscous bulk-fill composite applied with preheating, a sonic-activated bulk-fill composite, a flowable bulk-fill composite, an ORMOCER-based bulk-fill composite, and a conventional bulk-fill composite. Restorations will be clinically assessed at baseline, 1 month, 6 months, and 12 months for esthetic, functional, and biological outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Patients aged 18 years and older * Patients in good general health (systemically healthy) * Patients with good oral hygiene * Patients with good periodontal health * Presence of at least one posterior tooth requiring restoration * Teeth must be vital and asymptomatic * Teeth must have proximal contact with adjacent teeth on both mesial and distal surfaces * Teeth must be in functional occlusion with an antagonist tooth * Presence of at least one carious lesion not extending deeper than two-thirds of dentin, with a clinical ICDAS code ≤ 3 * Absence of periapical pathology confirmed by radiographic evaluation * Patients who voluntarily agree to participate and provide written informed consent Exclusion Criteria: * Presence of any systemic disease * Poor oral hygiene * Presence of active or severe periodontal disease * Teeth with previous restorations or endodontic treatment * Non-vital (devitalized) or symptomatic teeth * Patients who are pregnant or breastfeeding * Patients undergoing active orthodontic treatment * Presence of parafunctional habits (e.g., bruxism) or xerostomia * Current tobacco use or history of heavy smoking * Patients unwilling or unable to attend follow-up visits

Primary outcome measure(s)

  • Clinical performance according to FDI criteria — Baseline (1 month), 6 months, and 12 months
    The clinical performance of posterior restorations will be evaluated according to World Dental Federation (FDI) criteria, including esthetic, functional, and biological properties.

Trial sites (1)

FacilityCityRegionStatus
Atatürk University Faculty of Dentistry Erzurum Turkey (Türkiye)

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Other trials for the same condition

Clinical Success of Single-Color Universal Resin Composites Active, not recruiting
Clinical Performance of Novel Alkasite Restorative Material "Cention Forte" in Class II Restorations Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07518537 on ClinicalTrials.gov ↗ ← All trials in Turkey