Bulk-Fill Composite Restorations: Clinical Evaluation

Official title

Clinical Evaluation of Restorations Performed With Bulk-Fill Composites of Different Technologies According to FDI Criteria: A Randomized Controlled Clinical Follow-Up Study

Overview

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.

Detailed description

This randomized controlled clinical follow-up study is planned to evaluate the clinical performance of posterior restorations performed with five different bulk-fill composite materials representing distinct technological approaches. The materials to be investigated 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.

The study will be conducted in patients requiring direct posterior restorations. After cavity preparation and restorative procedures performed according to the manufacturers' instructions, restorations will be placed using the assigned bulk-fill composite material. Clinical evaluations will be performed according to the World Dental Federation (FDI) criteria. The restorations will be assessed in terms of esthetic, functional, and biological properties.

Follow-up examinations will be carried out at baseline, 1 month, 6 months, and 12 months. The primary aim of the study is to compare the short-term clinical performance of bulk-fill composite materials with different technological characteristics. The findings are expected to provide clinically relevant information regarding the effectiveness and reliability of these restorative materials in posterior teeth.

Interventions

• Other 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.
• Other 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.
• Other 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.
• Other 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.
• Other 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.

Primary outcome measures

• Clinical performance according to FDI criteria [Time frame: Baseline (1 month), 6 months, and 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Atatürk University Faculty of Dentistry — Erzurum

Identifiers

NCT: NCT07518537 · TDH-2026-17149 · TDH-2026-17149

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗