Efficacy of Silver Diamine Fluoride and Its Parental Perception

Study Overview
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Brief Summary
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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.

Detailed Description
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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 RECALDENT™* (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.

Official Title
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Parental Perception of Silver Diamine Fluoride Staining and Its Efficacy on Caries Arrestment in Comparison to Sodium Fluoride With Casein Phosphopeptide-amorphous Calcium Phosphate

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Drug: silver diamine fluoride
* Drug: MI Varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal healthy children without any systemic disease ASA 1 physical status. Children with at least one carious dentin lesion in their primary teeth, code 5 (ICDAS II) Exclusion Criteria: Children who suffer from major systemic diseases and require long term medications. Children refuse the study intervention. Children with silver or milk product sensitivity. Presence of any gingival or perioral ulceration or stomatitis. Tooth with abscess, fistula or severe pain.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: topical application of silver diamine fluoride<br>38% silver diamine fluoride liquid | Drug: silver diamine fluoride<br>* 38% silver diamine fluoride liquid will be applied with a brush<br>* Other names: SDF;|
| Active Comparator: Group 2: topical application of MI varnish.<br>MI Varnish:5% sodium fluoride varnish which also contains RECALDENT™* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate | Drug: MI Varnish<br>* topical fluoride varnish with calcium and phosphate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |