Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries

Study Overview
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Brief Summary
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The present study aims to evaluate, through a controlled clinical randomized study,the effectiveness of silver diamine fluoride in arresting dentin caries lesions in primary molars when compared to atraumatic restorative treatment.

Detailed Description
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The present controlled clinical randomized study aiming at evaluating the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions on the occlusal surface of primary molars when compared to atraumatic restorative treatment (ART). For this, 118 healthy children aged 2-5 years with at least one active dentin carious lesion, with no signs of pain or pulp involvement. The participants will be allocated randomly to one of two treatment groups: (1) Test Group - SDF and (2) Control Group - ART. The International Caries Detection and Assessment System (ICDAS) will be used to determine caries diagnosis and activity. In both groups, the guardians and children will receive oral hygiene instructions and will be advised about eating habits and fluoride dentifrice use.The clinical success will be verified through examinations performed by a blinded operator, after 3, 6 and 12 months, with clinical evaluations to detect caries arresting, representing the primary outcome of the study.

Official Title
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Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Deciduous Molars: a Controlled and Randomized Clinical Trial

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Procedure: Atraumatic Restorative Treatment
* Other: Silver Diamine Fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CHILDREN aged 2 to 5 years; who are in good general health; have at least one active dentin carious lesion on the occlusal surface of primary molars corresponding to ICDAS codes 5 or 6. Exclusion Criteria: CHILDREN with systemic or neurological diseases; whose families intend to move from Rio de Janeiro next year; with a history of allergy to silver or any substance present in the different materials to be used for treatment. TEETH with spontaneous or provoked pain, dental mobility or radiographic signs of involvement or possible pulp involvement; shows possible pulp involvement by radiographic examination

Ages Eligible for Study
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Minimum Age: 2 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: Atraumatic Restorative Treatment<br> | Procedure: Atraumatic Restorative Treatment<br> <br> * Other names: Ketac Molar Easymix;|
| Experimental: Silver Diamine Fluoride<br> | Other: Silver Diamine Fluoride<br> <br> * Other names: Cariostop 30% Biodinâmica;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries arresting | The main outcome of the study will be the observation of the proportion of arrested caries lesions in the test group, compared to the control group. | The follow-up oral examinations will be conducted every 3 months for 48 months totally | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the intervention visit | Time (in minutes) spent on each type of intervention (DFP x ART) | 1 year | 
| Cost | The cost of each treatment will be recorded and compared to each other | 1 year | 
| Aesthetic perception and treatment satisfaction | Information on aesthetic perception will be obtained through a questionnaire, addressed to parents / guardians. | First appointment, 3,6 and 12 months after treatment. | 
| Anxiety | A facial imaging scale will be used to assess the degree of anxiety of children 3 years of age or older. before and after first exam and treatment appointments. | From allocation up to two weeks. | 
| Quality of life assessment | Information about quality of life will be obtained through the questionnaire Brazilian Early Childhood Oral Health Impact Scale (B-ECOHIS), addressed to parents / guardians. | First appointment,15 days and 3 months after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth, Deciduous, Dental Caries, Glass Ionomer Cements, Dental Atraumatic Restorative Treatment, Cariostatic Agents, Fluorides