Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces

Study Overview
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Brief Summary
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This study aims to verify the actual possibility of using silver diammine fluoride (SDF) in arresting enamel caries lesions on occlusal surfaces of primary molars in babies. Besides, the cost-efficacy and also parental acceptability of using SDF will be evaluated. For this, 100 babies 1-3 years will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Barueri, Sao Paulo, Brazil. The caries diagnosis will be conducted using the International Caries Detection and Assessment System (ICDAS). Babies with initial lesions will be randomized concerning the treatment in Group A (SDF) and Group B (fluoride varnish). Participants will be examined in the baseline and followed by 6, 12, 18 and 24 months. As primary outcome, caries progression into dentine will be considered. Acceptability reported by parents after treatments, the time and estimated money spent for treating will also be collected. Social and biological data that could be related to efficacy of techniques will be also collected. Multilevel analyses will be performed to check which technique will be most effective and possible factors associated to its efficacy. Discomfort, acceptability and costs will be compared between/among the approaches used to arrest enamel caries lesions.

Official Title
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Efficacy, Cost-efficacy and Parental Acceptability of Using Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Silver diamine fluoride
* Other: Fluoride Varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Babies 1 to 3 years; Babies with initial dental caries lesion. Exclusion Criteria: Parents who do not consent.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 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: Silver Diamine Fluoride<br>Control treatment | Other: Silver diamine fluoride<br>* Treatment of initial dental caries lesion in occlusal surface using the silver diamine fluoride.<br>* Other names: SDF;|
| Active Comparator: Fluoride Varnish<br>Test treatment | Other: Fluoride Varnish<br>* Treatment of initial dental caries lesion in occlusal surface using the fluoride varnish<br>* Other names: sodium fluoride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of caries lesions which progressed to dentine | Assessment of caries lesions severity in order to identify those which progressed to dentine (ICDAS scores 4 to 6) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental acceptability to the treatment using a VAS scale | Parents will be asked to report their satisfaction with the treatment using a VAS scale | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental caries, deciduous tooth