NCT02789202

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

4.2 years

First QC Date

May 25, 2016

Last Update Submit

March 20, 2018

Conditions

Dental Caries

Keywords

dental cariesdeciduous tooth

Outcome Measures

Primary Outcomes (1)

  • Number of caries lesions which progressed to dentine

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

    24 months

Secondary Outcomes (1)

  • Parental acceptability to the treatment using a VAS scale

    12 months

Other Outcomes (1)

  • Direct and Indirect Costs of initial procedures and consequent interventions during 24 months

    24 months

Study Arms (2)

Silver Diamine Fluoride

EXPERIMENTAL

Control treatment

Other: Silver diamine fluoride

Fluoride Varnish

ACTIVE COMPARATOR

Test treatment

Other: Fluoride Varnish

Interventions

Silver diamine fluorideOTHER

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

Also known as: SDF
Silver Diamine Fluoride
Fluoride VarnishOTHER

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

Also known as: sodium fluoride
Fluoride Varnish

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Parents who do not consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

São Paulo, 05508000, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluorideSodium Fluoride

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsSodium CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Mariana Minatel Braga, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Associate professor

Study Record Dates

First Submitted

May 25, 2016

First Posted

June 2, 2016

Study Start

October 1, 2014

Primary Completion

December 1, 2018

Study Completion

August 1, 2020

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

BR(1)