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

NCT ID: NCT02789202

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2020-08-31

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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Silver Diamine Fluoride

Control treatment

Group Type: EXPERIMENTAL

Silver diamine fluoride

Intervention Type: OTHER

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

Fluoride Varnish

Test treatment

Group Type: ACTIVE_COMPARATOR

Fluoride Varnish

Intervention Type: OTHER

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

Interventions

Silver diamine fluoride

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

Intervention Type: OTHER

Fluoride Varnish

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

Intervention Type: OTHER

Other Intervention Names

SDF; sodium fluoride

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Parents who do not consent.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Mariana Minatel Braga

PhD, Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariana Minatel Braga, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of São Paulo

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

SDFtrials-03

Identifier Type: -

Identifier Source: org_study_id