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Early Childhood Caries (ECC) remains a global public health concern, necessitating minimally invasive, fluoride-based alternatives to conventional restorative therapy. Silver Diamine Fluoride (SDF), Sodium Fluoride with Casein Phosphopeptide-Amorphous Calcium Phosphate (NaF + CPP-ACP), and Acidulated Phosphate Fluoride (APF) gel are widely employed chemotherapeutic agents; however, comparative clinical evidence of their effectiveness in ECC management remains limited.
This randomized controlled clinical trial will evaluate and compare the efficacy of SDF gel, NaF + CPP-ACP, and APF gel in arresting and preventing ECC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cavitated/Non cavitated caries lesions involving only enamel | Experimental | Reversible pulpitis |
|
| Experimental arm including cavitated/ non cavitated caries lesions involving enamel,dentin but not p | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver Diamine Fluoride (SDF, 38%) | Drug | Silver diamine fluoride gel is applied in gel form |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dental caries arrest | A lesion was considered active if a blunt dental probe penetrated the dentinal surface easily, whereas arrested caries resisted probe penetration, indicating surface hardening. | Caries arrest will be assessed 6 months after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Dentistry, jazan University | Jizan | Jazan Region | Saudi Arabia |
We do not plan to share the IPD because we consider to continue the study for long term in future
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This three-arm phase 2 clinical trial will be conducted to evaluate the effectiveness of silver diamine fluoride (SDF) for preventing or arresting dental caries.
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| Sodium Fluoride with CPP-ACP | Drug | This is in a Topical fluoride varnish |
|
| Acidulated phospahate fluoride gel 1.23% | Drug | This is a topical fluoride application for 1 minute application |
|
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C024633 | silver diamine fluoride |
| D012969 | Sodium Fluoride |
| C447032 | casein phosphopeptide-amorphous calcium phosphate nanocomplex |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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