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NCT Number: NCT07518537

Bulk-Fill Composite Restorations: Clinical Evaluation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University Faculty of Dentistry

Erzurum, 25240, Turkey (Türkiye)

Location contact

Cemile Arslan, Research Asisistant

CONTACT

[email protected]

+905396845019

Cemile Arslan, Research Assistant

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermoviscous bulk-fill composite restoration

Other

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

Other

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

Other

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

Other

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

Other

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

Primary outcomes

  1. Clinical performance according to FDI criteria

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cemile Arslan, Research Assistant

CONTACT

[email protected]

+905396845019

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Collaborators

  • Atatürk University Scientific Research Projects Coordination Unit

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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