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

March 20, 2018 updated by: Mariana Minatel Braga, University of Sao Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05508000
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Parents who do not consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silver Diamine Fluoride
Control treatment
Other: Silver diamine fluoride
Treatment of initial dental caries lesion in occlusal surface using the silver diamine fluoride.
Other Names:
  • SDF
Active Comparator: Fluoride Varnish
Test treatment
Other: Fluoride Varnish
Treatment of initial dental caries lesion in occlusal surface using the fluoride varnish
Other Names:
  • sodium fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental acceptability to the treatment using a VAS scale
Time Frame: 12 months
Parents will be asked to report their satisfaction with the treatment using a VAS scale
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Direct and Indirect Costs of initial procedures and consequent interventions during 24 months
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Mariana Minatel Braga, PhD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

June 1, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDFtrials-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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