Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood Caries

Study Overview
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Brief Summary
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Arresting dental caries using silver diamine fluoride (SDF) has gained attention recently for the management of early childhood caries (ECC). However, black staining is one of its drawbacks. A possible affordable alternative can be Sodium Fluoride (NaF) supported with good oral hygiene induced by parental Motivational Interviewing (MI). The trial aims to compare the impact of SDF versus NaF supported by MI on lesion activity in preschool children.

Official Title
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Effectiveness of Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification for Arresting Early Childhood Caries: A Randomized Clinical Trial

Conditions
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Early Childhood Caries

Intervention / Treatment
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* Drug: Sodium Fluoride Varnish (5%)
* Behavioral: Motivational Interviewing
* Drug: SDF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged ≤ 4 years old. The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II) Children whose caregivers have means of communication (mobile phones). 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 and/or abscess. Parental refusal to participate in the study. Allergy or sensitivity to silver or any of the materials included in the study.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 4 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naf + MI<br>Sodium Fluoride Varnish 5% (Applied biannually) + two MI sessions: baseline face-to-face session and phone call after 3months. | Drug: Sodium Fluoride Varnish (5%)<br>* Applied at baseline<br>Behavioral: Motivational Interviewing<br>* Two MI sessions: face-to-face at baseline and phone call at 3 months<br>|
| Active Comparator: SDF<br>Silver Diamine fluoride 38% (Applied biannually) | Drug: SDF<br>* Applied bianually<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries Arrest | Percentage of arrested carious lesions | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries Increment | Number of new carious lesions will be assessed using decayed, missing (due to caries), and filled primary tooth surface index (dmfs) | 6 months | 
| Parental satisfaction | Parents will be asked if application was an easy process, pain free for their child and taste is acceptable. Answers will be on a 5 point Likert scale (Strongly agree, Agree, Neutral , Disagree, Strongly disagree). | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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38% SDF, 5% NaF, Motivational Interviewing, Preschoolers, ECC