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| ID | Type | Description | Link |
|---|---|---|---|
| TDH-2026-17149 | Other Grant/Funding Number | Atatürk University Scientific Research Projects Coordination Unit |
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| Name | Class |
|---|---|
| Atatürk University Scientific Research Projects Coordination Unit | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viscolor | Experimental | Participants assigned to this group will receive posterior restorations using a thermoviscous bulk-fill composite material applied after preheating according to the manufacturer's instructions. |
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| SonicFill | Experimental | Participants 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. |
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| Estelite Bulk Flow | Experimental | Participants assigned to this group will receive posterior restorations using a flowable bulk-fill composite material applied according to the manufacturer's instructions. |
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| Admira Fusion Xtra | Experimental | Participants assigned to this group will receive posterior restorations using an ORMOCER-based bulk-fill composite material applied according to the manufacturer's instructions. |
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| Filltek Bulkfill Composite | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cemile Arslan, Research Assistant | Contact | +905396845019 | cemilegonul15@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atatürk University Faculty of Dentistry | Erzurum | 25240 | Turkey (Türkiye) |
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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.
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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.
Participants assigned to this group will receive posterior restorations using a conventional bulk-fill composite material applied according to the manufacturer's instructions.
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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