Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution

Study Overview
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Brief Summary
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This study was conducted to assess the efficacy of 38% Silver Diamine fluoride and compare it with 5% sodium fluoride varnish in arresting interproximal caries in primary molars at 12 months follow-up. Bitewing radiographs were taken to diagnose as well as to assess caries depth at follow up visits. Each bitewing was scored based on ICCMS radiographic criteria and was compared (follow-ups to baseline)to check for caries arrest. Interproximal caries included in this study, according to ICCMS criteria, were at stages- RA - caries limited to outer half of enamel RA2 - caries limited to the inner half of enamel RA3 - caries limited to outer third of dentine RA4 - caries limited to middle third of dentine

Official Title
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Arrest of Interproximal Caries Lesion in Primary Molars With 38% Silver Diamine Fluoride Solution and 5% Sodium Fluoride Varnish: A Randomized Clinical Trial

Conditions
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Caries Arrested

Intervention / Treatment
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* Drug: Silver diamine fluoride
* Drug: Sodium fluoride varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 5 to 9 years. Presence of at least 2 primary molars with interproximal caries. Carious lesions of enamel or outer or middle third of dentin in primary molars, as assessed by bitewing radiographs with ICCMSTM scoring (RA1, RA2, RA3, RB4). Exclusion Criteria: 1. Presence of advanced carious lesions reaching inner third of dentin detected by bitewing radiographic examinations ICCMSTM (RC5, RC6). 3. Children or adolescents that refuse to participate in the study or present negative behaviours. 4. Teeth with premature hypermobility 5. Both physically and mentally disabled children

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 38% silver diamine fluoride<br> | Drug: Silver diamine fluoride<br>* Silver diamine fluoride is a topical medication composed of 25% silver, 5% fluoride, 8% ammonia, and 62% Deionized water, used to treat and prevent dental caries and relieve dentinal hypersensitivity.<br>* Other names: FAgamin SDF38%;|
| Active Comparator: 5% sodium fluoride varnish<br> | Drug: Sodium fluoride varnish<br>* It is a topical application with an active ingredient of 5% sodium fluoride(22,600ppm fluoride).it prolongs the contact time between the fluoride and tooth surface and promotes remineralization and inhibits demineralization.<br>* Other names: VOCO profluorid varnish;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries arrest | Assessment with bitewing radiographs based on ICCMS radiographic scoring system | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caries arrest ,interproximal caries, primary molars, SDF