The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth

Study Overview
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Brief Summary
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To assess the antibacterial effect of Nanosilver Fluoride (NSF) in relation to caries activity in dentin caries lesions of primary teeth in comparison to Silver Diamine Fluoride (SDF).

Detailed Description
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Fifty children aged 4 to 6 years old with active dentin caries lesions (score 5 according to International Detection and Assessment System (ICDAS II) criteria) will be enrolled in the study. They will be equally and randomly allocated into 2 groups: a group receiving NSF and a control group receiving SDF treatment. Microbiological samples will be collected from the carious lesions and from unstimulated saliva at the baseline and at the 1 and 3 months' follow-up appointments. Bacterial counts will be assessed using Mitis Salivarius agar (selective culture media for S. mutans) and Rogosa agar (selective culture media for lactobacilli), and the results will be expressed in colony-forming units. Data regarding the children's oral health will be collected and their dmf index will be scored. The arrest of active carious lesions will be measured at the follow-up appointments according to ICDAS II criteria.

Official Title
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The Antibacterial Effect of Nanosilver Fluoride in Relation to Caries Activity in Primary Teeth: a Randomized Controlled Clinical Trial

Conditions
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Primary Teeth, Microbial Colonization, Caries, Dental Caries in Children

Intervention / Treatment
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* Drug: Nanosilver Fluoride (NSF)
* Drug: Silver diamine fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The presence of at least one active carious lesion on a primary tooth. 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, abscess, obvious discoloration of the tooth, or premature mobility. Reported usage of local or systemic antibiotics, chlorhexidine or fluoride mouthwashes within the last 2 weeks. Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases affecting salivary flow. Allergy or sensitivity to silver or any of the materials included in the study. Child weight less than 10 Kg (to avoid concerns for toxicity).

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Silver diamine fluoride<br>These active caries lesions will receive silver diamine fluoride treatment | Drug: Silver diamine fluoride<br>* Silver Diamine Fluoride<br>* Other names: Advantage Arrest by Elevate Oral care, 38% SDF;|
| Experimental: Nanosilver fluoride<br>These active caries lesions will receive nanosilver fluoride treatment | Drug: Nanosilver Fluoride (NSF)<br>* Optimized synthesis of Nanosilver Fluoride<br>* Other names: Nanosilver Fluoride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibacterial Effect in Active Dental Caries Lesions | Measuring the percent change in prevalence of cariogenic bacteria using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected immediately before application of the intervention (baseline) and one month after the intervention application (1 month follow-up). The CFU counts will be used to calculate the percentage change in bacterial prevalence which will be used for assessment and reporting results | 1 month | 
| The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions | A statistical analysis will be done to correlate between the change in number of available cariogenic bacteria from baseline to 1 month (measured in colony forming units) and the caries activity of the lesion (as specified by the international caries detection and assessment system (ICDAS II) criteria. | 1 month | 
| Antibacterial Effect in Unstimulated Saliva Samples | Measuring the change in prevalence of cariogenic bacteria using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application. | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions | A statistical analysis will be done to correlate between the change in number of available cariogenic bacteria from baseline to 3 months (measured in colony forming units) and the caries activity of the lesion (as specified by the international caries detection and assessment system (ICDAS II) criteria. | 3 month | 
| Antibacterial Effect in Active Dental Caries Lesions | Measuring the change in prevalence of cariogenic bacteria from baseline to 3 months using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application. | 3 month | 
| Antibacterial Effect in Unstimulated Saliva Samples | Measuring the change in prevalence of cariogenic bacteria from baseline to 3 months using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SDF, Nano silver fluoride, silver diamine fluoride, antibacterial, caries arrest, microbiology, primary teeth, pediatric, clinical trial, nanosilver