Composite Resins, Dental Caries Class II
Conditions
Keywords
FDI Criteria, Clinical Evaluation, Bulkfill, Composite Resins, Thermoviscous, Sonicfill, Clinical Trial
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.
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
OTHERThermoviscous 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.
OTHERSonic-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.
OTHERFlowable 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.
OTHERORMOCER-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.
OTHERConventional 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.
Sponsors
Ataturk University
Atatürk University Scientific Research Projects Coordination Unit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
This study will use a randomized parallel-group design. Participants will be randomly assigned to one of the study groups, and all eligible posterior restorations within the same participant will be restored using the same assigned bulk-fill composite material. The number of restorations may vary among participants according to individual treatment needs.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTCemile Arslan, Research Assistant
Outcome results
None listed