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

U

University of Sao Paulo

Status

Unknown

Conditions

Dental Caries

Treatments

Other: Silver diamine fluoride
Other: Fluoride Varnish

Study type

Interventional

Funder types

Other

Identifiers

NCT02789202
SDFtrials-03

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

1 to 3 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Parents who do not consent.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Silver Diamine Fluoride
Experimental group
Description:
Control treatment
Treatment:
Other: Silver diamine fluoride
Fluoride Varnish
Active Comparator group
Description:
Test treatment
Treatment:
Other: Fluoride Varnish

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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