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Early childhood caries is a major public health problem affecting preschool children worldwide. Silver Diamine Fluoride is a well-established non-invasive treatment for arresting caries; however, it causes black discoloration of treated lesions. Nano-Silver Fluoride has been introduced as an alternative that may arrest caries without discoloration.
This randomized clinical trial aims to compare the efficacy of Silver Diamine Fluoride and Nano-Silver Fluoride in arresting active dentin caries in primary teeth and to assess discoloration, post-operative pain, and parental satisfaction over a 12-month follow-up period.
This randomized clinical trial will be conducted on 30 children aged 3-5 years attending the outpatient clinic of Pediatric Dentistry, Faculty of Dentistry, Suez Canal University. Children with active dentin caries in primary molars will be randomly allocated into two groups: Silver Diamine Fluoride group and Nano-Silver Fluoride group.
Both materials will be applied topically without caries excavation. Clinical evaluation will be performed at baseline and at 1, 3, 6, 9, and 12 months using ICDAS criteria, visual and tactile examination, assessment of post-operative pain, discoloration through standardized photographs, and parental satisfaction questionnaires.
The primary outcome is caries arrest. Secondary outcomes include discoloration, pain, and parental satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Nano-Silver Fluoride | Experimental | Topical application of Nano-Silver Fluoride varnish containing silver nanoparticles, chitosan, and fluoride applied to active dentin caries lesions in primary molars. Application will be performed twice: at baseline and after 6 months, without caries excavation or restoration. |
|
| Arm B: Silver Diamine Fluoride | Active Comparator | Topical application of 38% Silver Diamine Fluoride varnish applied to active dentin caries lesions in primary molars. Application will be performed twice: at baseline and after 6 months, without caries excavation or restoration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nano-Silver Fluoride | Drug | Chitosan (28,585 μg/ml), Silver (376.5 μg/ml) and Sodium fluoride (5028.3 μg/ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Caries arrest of active dentin caries | Arrest of caries assessed clinically by hardness of dentin using blunt periodontal probe and ICDAS criteria | 1, 3, 6, 9 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Discoloration of carious lesions | Assessment of color change using standardized pre- and post-operative photographs | 1, 3, 6, 9 and 12 months |
| Post-operative pain | Presence or absence of pain assessed through parental interview |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khaled Abdelmonem Sayed Assistant Lecturer at Pediatric Dentistry Department, Master Holder | Contact | +201114537612 | kasayed@msa.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, MSA University | Giza | Giza Governorate | 12611 | Egypt |
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| Silver Diamine Fluoride | Drug | 38% Silver Diamine Fluoride |
|
| 1, 3, 6, 9 and 12 months |
| Parental satisfaction | Evaluation using a structured parental satisfaction questionnaire | 1, 3, 6, 9 and 12 months |
| ID | Term |
|---|---|
| C024633 | silver diamine fluoride |
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