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This randomized clinical trial aims to compare the clinical and radiographic performance of four direct restorative materials used for restoring carious primary molars in children. Eligible children aged 4-8 years with posterior primary molars requiring direct restoration will be randomly allocated (1:1:1:1) to receive one of the following materials: an alkasite restorative material (Cention N), a self-cure bulk-fill resin composite (Stela; SDI), a conventional light-cured nanohybrid resin composite (Beautifil II), or a resin-modified glass ionomer cement (Riva Light Cure). Restorations will be evaluated using the Fédération Dentaire Internationale (FDI) World Dental Federation criteria. Postoperative sensitivity will be assessed at 48 hours using a 0-10 visual analogue scale (VAS). Clinical and radiographic follow-up assessments will be conducted at baseline and at scheduled recall visits
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Cention N | Experimental |
| |
| Group B: Stela (Self-cure Bulk-fill Composite) | Experimental |
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| Group C: Beautifil II (Nanohybrid Composite) | Active Comparator |
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| Group D: Riva Light Cure (RMGIC) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cention N | Device | Alkasite restorative material (Cention N) used for direct restoration of carious primary molars according to the manufacturer's instructions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Restoration success based on FDI criteria (clinical and radiographic evaluation) | 6 months | |
| Restoration success based on FDI criteria (clinical and radiographic evaluation) | Clinical and radiographic success of restorations assessed using the Fédération Dentaire Internationale (FDI) World Dental Federation criteria (scores 1-5). Scores 1-3 are considered clinically acceptable; scores 4-5 are considered clinically unacceptable (repair or replacement indicated). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hosam Hassan Metwalli | Contact | +201147957878 | dr.hosamhassan2@gmail.com |
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individual participant data will not be shared to protect participant privacy and confidentiality, in accordance with the informed consent provided by the participants and the ethical approval granted for this study
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Four-arm, parallel-group randomized clinical trial (1:1:1:1).
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Outcome assessment was performed by a blinded assessor who was unaware of group allocation; operator blinding was not feasible due to differences in material handling.
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| Stela, SDI, Australia | Device | Self-cure bulk-fill resin composite (Stela; SDI) used for direct restoration of carious primary molars according to the manufacturer's instructions. |
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| Beautifil II, Shofu, Japan | Device | Light-cured nanohybrid resin composite (Beautifil II) used for direct restoration of carious primary molars according to the manufacturer's instructions. |
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| Resin modified glass ionomer cement | Device | Resin-modified glass ionomer cement (Riva Light Cure) used for direct restoration of carious primary molars according to the manufacturer's instructions. |
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