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Clinical Trials/NCT02789202
NCT02789202
Unknown
Not Applicable

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

University of Sao Paulo1 site in 1 country100 target enrollmentOctober 2014
ConditionsDental Caries

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Caries
Sponsor
University of Sao Paulo
Enrollment
100
Locations
1
Primary Endpoint
Number of caries lesions which progressed to dentine
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
August 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mariana Minatel Braga

PhD, Associate professor

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Parents who do not consent.

Outcomes

Primary Outcomes

Number of caries lesions which progressed to dentine

Time Frame: 24 months

Assessment of caries lesions severity in order to identify those which progressed to dentine (ICDAS scores 4 to 6)

Secondary Outcomes

  • Parental acceptability to the treatment using a VAS scale(12 months)

Study Sites (1)

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