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

Not Applicable

• Conditions: Dental Caries
• Interventions: Other: Silver diamine fluoride; Other: Fluoride Varnish

• Registration Number: NCT02789202
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-21
• Primary Completion: 2018-12
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Babies 1 to 3 years;
• Babies with initial dental caries lesion.

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Exclusion Criteria

• Parents who do not consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver Diamine Fluoride	Silver diamine fluoride	Control treatment
Fluoride Varnish	Fluoride Varnish	Test treatment

Primary Outcome Measures

Name	Time	Method
Number of caries lesions which progressed to dentine	24 months	Assessment of caries lesions severity in order to identify those which progressed to dentine (ICDAS scores 4 to 6)

Secondary Outcome Measures

Name	Time	Method
Parental acceptability to the treatment using a VAS scale	12 months	Parents will be asked to report their satisfaction with the treatment using a VAS scale

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 São Paulo, Brazil