Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride

Study Overview
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Brief Summary
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This study will be conducted to test the cariostatic effect of Nano Silver Fluoride in a comparison to Silver Diamine Fluoride in a group of preschool children.

Detailed Description
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Silver Diamine Fluoride has offered a non-invasive and easily performed method to manage dental caries in very young children.Studies shows that SDF has been proven to arrest caries in cavitated lesions and to prevent caries in sound teeth as Fluoride is effective in enhancing the remineralization of dental hard tissue and silver ion acts as an antibacterial agent. However, It was found that silver causes staining to the dental tissues with a black discoloration, which can be considered to be a main drawback specifically, when it is used on anterior teeth. Nano-silver fluoride varnish preparation showed high efficacy in arresting caries progression in primary teeth without causing black discoloration to the tissues.Silver diamine fluoride (SDF) . Benefits for patient: Non-invasive treatment leading to reduce patient anxiety and stress. No drilling and filling. Protects against further caries progression. Benefits for the practitioner: Provide alternative treatment options. Pain-free procedure that facilitates child management and saves time. Benefits for the community: Increasing overall oral health Provides more information by testing new material To provide better service quality.

Official Title
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Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride in a Group of Preschool Children

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Drug: Nano-Silver Fluoride
* Drug: Silver diamine fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged from 3 to 5 years clinical diagnosis of active dentinal caries in primary teeth Co-operative participants and free of any systemic diseases Exclusion Criteria: Children whose parents refuse to sign consent Primary teeth with pulp involvement, pain, mobility, abscess, sinus, fistula; or discoloration related to tooth non-vitality.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 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>38% Silver Diamine Fluoride varnish the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges. No excavation will be done to the infected dentin tissue prior to the application of the agent. Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls. After isolation, a single drop SDF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly. Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent | Drug: Silver diamine fluoride<br>* 38% silver diamine fluoride<br>* Other names: SDF;|
| Experimental: Nano-Silver Fluoride<br>Nano-Silver fluoride varnish preparation the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges. No excavation will be done to the infected dentin tissue prior to the application of the agent. Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls. After isolation, a single drop NSF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly. Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent | Drug: Nano-Silver Fluoride<br>* NSF is a varnish which has been introduced as experimental formulation . the laboratory synthesis of NSF was carried out in a nano techonolgy center .<br>* Other names: NSF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caries lesion activity and severity assessment using Nyvad criteria | visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling ) | baseline | 
| caries lesion activity and severity assessment using Nyvad criteria | visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling ) | 3 weeks | 
| caries lesion activity and severity assessment using Nyvad criteria | visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling ) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICDAS II | Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin ) | baseline | 
| ICDAS II | Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin ) | 3 weeks | 
| ICDAS II | Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin ) | 6 months |