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

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ClinicalTrials.gov Identifier: NCT02789202
Recruitment Status : Active, not recruiting
First Posted : June 2, 2016
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Mariana Minatel Braga, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Dental Caries Other: Silver diamine fluoride Other: Fluoride Varnish Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy, Cost-efficacy and Parental Acceptability of Using Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces
Study Start Date : October 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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 Name: SDF

Active Comparator: Fluoride Varnish
Test treatment
Other: Fluoride Varnish
Treatment of initial dental caries lesion in occlusal surface using the fluoride varnish
Other Name: sodium fluoride




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Direct and Indirect Costs of initial procedures and consequent interventions during 24 months [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Parents who do not consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789202


Locations
Brazil
University of São Paulo
São Paulo, Brazil, 05508000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Mariana Minatel Braga, PhD University of Sao Paulo

Responsible Party: Mariana Minatel Braga, PhD, Associate professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02789202     History of Changes
Other Study ID Numbers: SDFtrials-03
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Keywords provided by Mariana Minatel Braga, University of Sao Paulo:
dental caries
deciduous tooth

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Sodium Fluoride
Fluorides, Topical
Salicylic Acid
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents