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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02789202
• Other study ID #: SDFtrials-03
• Status: Active, not recruiting
• Phase: N/A
• First received: May 25, 2016
• Last updated: March 20, 2018
• Start date: October 2014
• Est. completion date: August 2020

Study information

• Verified date: March 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

Inclusion Criteria:

• Babies 1 to 3 years;

• Babies with initial dental caries lesion.

Exclusion Criteria:

• Parents who do not consent.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Silver diamine fluoride
Treatment of initial dental caries lesion in occlusal surface using the silver diamine fluoride.
• Fluoride Varnish
Treatment of initial dental caries lesion in occlusal surface using the fluoride varnish

Locations

Country	Name	City	State
Brazil	University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Direct and Indirect Costs of initial procedures and consequent interventions during 24 months		24 months
Primary	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	Parental acceptability to the treatment using a VAS scale	Parents will be asked to report their satisfaction with the treatment using a VAS scale	12 months