Bulk-Fill Composite Restorations: Clinical Evaluation
Clinical Evaluation of Restorations Performed With Bulk-Fill Composites of Different Technologies According to FDI Criteria: A Randomized Controlled Clinical Follow-Up Study
1 other identifier
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2026
CompletedFirst Posted
Study publicly available on registry
April 8, 2026
CompletedStudy Start
First participant enrolled
May 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 20, 2027
April 8, 2026
April 1, 2026
1.1 years
March 31, 2026
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical performance according to FDI criteria
The clinical performance of posterior restorations will be evaluated according to World Dental Federation (FDI) criteria, including esthetic, functional, and biological properties.
Baseline (1 month), 6 months, and 12 months
Study Arms (5)
Viscolor
EXPERIMENTALParticipants assigned to this group will receive posterior restorations using a thermoviscous bulk-fill composite material applied after preheating according to the manufacturer's instructions.
SonicFill
EXPERIMENTALParticipants assigned to this group will receive posterior restorations using a sonic-activated bulk-fill composite material with reduced viscosity during placement, according to the manufacturer's instructions.
Estelite Bulk Flow
EXPERIMENTALParticipants assigned to this group will receive posterior restorations using a flowable bulk-fill composite material applied according to the manufacturer's instructions.
Admira Fusion Xtra
EXPERIMENTALParticipants assigned to this group will receive posterior restorations using an ORMOCER-based bulk-fill composite material applied according to the manufacturer's instructions.
Filltek Bulkfill Composite
EXPERIMENTALParticipants assigned to this group will receive posterior restorations using a conventional bulk-fill composite material applied according to the manufacturer's instructions.
Interventions
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.
Posterior restorations in this group will be performed using a flowable bulk-fill composite material according to the manufacturer's instructions.
Posterior restorations in this group will be performed using an ORMOCER-based bulk-fill composite material according to the manufacturer's instructions.
Posterior restorations in this group will be performed using a conventional bulk-fill composite material according to the manufacturer's instructions.
Posterior restorations in this group will be performed using a thermoviscous bulk-fill composite material applied after preheating according to the manufacturer's instructions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atatürk University Faculty of Dentistry
Erzurum, 25240, Turkey (Türkiye)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants and outcome assessors will be blinded to the group allocation. The operator performing the restorations will not be blinded due to the different handling characteristics and application procedures of the tested bulk-fill composite materials.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant in Restorative Dentistry
Study Record Dates
First Submitted
March 31, 2026
First Posted
April 8, 2026
Study Start
May 20, 2026
Primary Completion (Estimated)
June 20, 2027
Study Completion (Estimated)
July 20, 2027
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share