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This randomized split-mouth clinical trial aims to evaluate the clinical performance of bioactive restorative materials used in Class II restorations in permanent posterior teeth. The study compares a giomer-based bulk-fill restorative material, a giomer restorative material, and a resin-modified glass ionomer cement in terms of clinical success and overall clinical performance. Patients requiring at least three Class II restorations in posterior teeth are treated under standardized clinical conditions. Clinical evaluations are performed at baseline and follow-up visits to assess short- and long-term outcomes.
This is a single-center, randomized, controlled split-mouth clinical trial conducted at Hacettepe University Faculty of Dentistry. The aim of the study is to compare the clinical performance of bioactive restorative materials used in Class II posterior restorations.
Eligible patients requiring at least three Class II restorations in permanent posterior teeth are included in the study. Each patient receives restorations with different bioactive restorative materials in separate treatment sites according to a split-mouth design. The tested materials include a giomer-based bulk-fill restorative material, a giomer restorative material, and a resin-modified glass ionomer cement. Randomization is used to assign the restorative materials to the treatment sites.
All restorative procedures are performed under standardized clinical protocols. Clinical performance is evaluated using modified FDI criteria.
Follow-up evaluations are planned at 6, 12, and 24 months after treatment. The 6-month results are used for interim analysis, while long-term follow-up will assess the durability and clinical success of the restorative materials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Giomer Restorative Material | Experimental | Class II posterior restorations restored with a giomer restorative material under standardized clinical conditions. |
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| Giomer-Based Bulk-Fill Restorative Material | Experimental | Class II posterior restorations restored with a giomer-based bulk-fill restorative material under standardized clinical conditions. |
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| Resin-Modified Glass Ionomer Cement | Experimental | Class II posterior restorations restored with a resin-modified glass ionomer cement under standardized clinical conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Giomer Restorative Material | Device | Class II posterior restorations restored with a giomer restorative material according to the manufacturer's instructions under standardized clinical conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention and fracture of restorations | Retention and fracture of Class II restorations will be evaluated using modified FDI World Dental Federation criteria by a single examiner. Restorations will be scored based on the presence of loss of retention, fracture, or chipping. A score of 1 (excellent) or 2 (good) will be considered clinically successful. | 6 Months after restoration placement" |
| Marginal adaptation of restorations | Marginal adaptation will be assessed using modified FDI criteria by a single examiner. The presence of marginal gaps or discrepancies will be evaluated using visual inspection. | 6 Months after restoration placement" |
| Surface luster of restorations | Surface luster will be assessed using modified FDI criteria by a single examiner. The surface gloss and texture of restorations will be evaluated. | 6 Months after restoration placement" |
| Postoperative sensitivity | Postoperative sensitivity will be assessed using modified FDI criteria by a single examiner. Sensitivity will be evaluated based on clinical examination and patient-reported symptoms. | 6 Months after restoration placement" |
| Secondary caries | Secondary caries will be evaluated using clinical and radiographic examination according to modified FDI World Dental Federation criteria by a single examiner. Radiographic evaluation will be used to detect recurrent caries and any pathological findings adjacent to the restorations. | 6 Months after restoration placement" |
| Measure | Description | Time Frame |
|---|---|---|
| Restoration survival | Restoration survival will be evaluated at 12 and 24 months based on the presence of restorations in function without the need for repair or replacement. Failures will include restoration loss, fracture requiring replacement, or the presence of secondary caries leading to restoration replacement. | 12 and 24 months after restoration placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elif Öztürk, PhD | Hacettepe University Faculty of Dentistry, Department of Restorative Dentistry | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University Faculty of Dentistry, Department of Restorative Dentistry | Ankara | 06230 | Turkey (Türkiye) |
Individual participant data sharing plans have not yet been determined.
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This study uses a split-mouth design in which each participant receives different restorative materials in separate Class II cavities.
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Participants and outcome assessors were blinded to the restorative material assigned to each treatment site. The operator was aware of the material allocation during the restorative procedures.
| Giomer-Based Bulk-Fill Restorative Material | Device | Class II posterior restorations restored with a giomer-based bulk-fill restorative material according to the manufacturer's instructions under standardized clinical conditions. |
|
| Resin-Modified Glass Ionomer Cement | Device | Class II posterior restorations restored with a resin-modified glass ionomer cement according to the manufacturer's instructions under standardized clinical conditions. |
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