Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries

Study Overview
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Brief Summary
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Aim of the study: To evaluate and compare the clinical cariostatic efficacy of NSF with 38% SDF solution after sex and twelve months in arresting ECC lesions. The Null hypothesis will be that no statistically significant difference will be detected between the two groups in the arrest of carious lesions in children with ECC.

Official Title
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Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries (a Randomized Clinical Trial)

Conditions
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Early Childhood Caries

Intervention / Treatment
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* Drug: Nanosilver
* Drug: Silver diamine fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children younger than 4 years old. The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II) Completion of an informed consent to participate in the study. Exclusion Criteria: Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess, obvious discoloration of the tooth and premature hypermobility. Parental refusal to participate in the study. Allergy or sensitivity to silver or any of the materials included in the study.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br> | Drug: Nanosilver<br>* preventive material for arresting caries<br>|
| Active Comparator: group 2<br> | Drug: Silver diamine fluoride<br>* preventive material for arresting caries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caries arrest | percentage of arresting caries in primary teeth | 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing parental satisfaction and adverse effects with interventions | assessed by a self-rated questionnaire with responses on a 4-point Likert scale ranging from very satisfied, satisfied, unsatisfied, to very unsatisfied - Parents were also asked about adverse effects | 6 months | 
| Evaluating oral health related quality of life of children and their families. | by using the Arabic version of the Early Childhood Oral Health Impact Scale (A-ECOHIS) | 6 months and 1 year | 
| Assessing caries increment on remaining teeth in the oral cavity other than the tooth/ teeth receiving the preventive agent | caries increment which is the number of new caries lesions developed over the study period detected using dmfs (change in dmfs score) | 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caries arrest, early childhood caries, Nanosilver fluoride