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because of corona virus epidemic
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This randomized clinical trial aims to compare the effectiveness of two topical fluoride application protocols, namely 38% silver diamine fluoride and sodium fluoride with added casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in arresting dental caries in children.
The present randomized clinical study is aiming to evaluate the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions when compared to MI Varnish a 5% sodium fluoride varnish which also contains RECALDENTâ„¢* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate. For this, healthy children aged 4-8 years with at least one active dentin carious lesion will be allocated randomly to one of two treatment groups: Group (1) SDF and Group (2) MI Varnish. Each participant will be assigned to one treatment group to avoid the possible synergistic effect of the different agents.
Parents/ guardians of each child will be fully informed regarding the study design, objectives and probable advantages and side effects especially the black discoloration of SDF before their involvement by written consent. The International Caries Detection and Assessment System (ICDAS II) will be used to determine caries diagnosis and activity.visual and tactile examination will be done with a WHO probe to assess the primary outcome. the secondary outcome will be conducted by a questionnaire given to the parents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: topical application of silver diamine fluoride | Experimental | 38% silver diamine fluoride liquid |
|
| Group 2: topical application of MI varnish. | Active Comparator | MI Varnish:5% sodium fluoride varnish which also contains RECALDENTâ„¢* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silver diamine fluoride | Drug | 38% silver diamine fluoride liquid will be applied with a brush |
|
| Measure | Description | Time Frame |
|---|---|---|
| caries arrestment | The measure will be done using international caries detection and assessment system II (ICDAS II) criteria for diagnosing active and arrested caries by WHO probe | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Parent perception | parental perception for silver diamine fluoride staining will be conducted by questionnaire given to the parents | 0 - 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| al-Ameriya dental specialized center | Baghdad | Al-karkh | 10 | Iraq |
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| ID | Term |
|---|---|
| C024633 | silver diamine fluoride |
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| MI Varnish | Drug | topical fluoride varnish with calcium and phosphate |
|