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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02789202

Enrollment

100

Registered

2016-06-02

Start date

2014-10-31

Completion date

2020-08-31

Last updated

2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

dental caries, deciduous tooth

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.

Interventions

OTHERSilver diamine fluoride

Treatment of initial dental caries lesion in occlusal surface using the silver diamine fluoride.

OTHERFluoride Varnish

Treatment of initial dental caries lesion in occlusal surface using the fluoride varnish

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 3 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Parents who do not consent.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Other

Measure	Time frame
Direct and Indirect Costs of initial procedures and consequent interventions during 24 months	24 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026