NCT05638217

Efficacy of the Use of Silver Diamine Fluoride and Sodium Fluoride Varnish for the Treatment of Caries in Children

Prospective Cohort Study: Efficacy of the Use of 38% Silver Diamine Fluoride and 5% Sodium Fluoride Varnish in Patients 4 to 12 Years for the Treatment of Caries and Its Association With Other Aspects of Relevance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 199 (actual)
• Sponsor: Universidad Mayor de San Simón · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to identify the efficacy of silver diamine fluoride 38% followed by sodium fluoride varnish 5% in a population with untreated dental caries age range 4 to 12 years old. The main questions to answer are * Efficacy of treatment of active tooth decay with the treatment protocol of 38% silver diamine fluoride and 5% sodium fluoride varnish. * Clinical evaluation of tooth decay treated with 38% silver diamine fluoride and 5% sodium fluoride varnish in quality of hardness, color change and caries progression. * Explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with: i. Reduction of oral pain caused by the presence of carious lesions. ii. Improvement in gingival oral health. iii. Changes in general nutritional status through measurements of height, weight, hemoglobin levels and nutritional survey. The participants will be identified, charted (with nutritional surveys and parameters), as well as treated and compared in a six- and twelve-month period, where researchers will clinically identify the association between the use of this protocol and the efficacy of such, as well as other related nutritional aspects.

Conditions

• Dental Caries in Children

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Silver diamine fluoride 38% followed by Sodium fluoride varnish 5%	1)Completely drying of the affected area 2)10 microliters of silver diamine fluoride 38% (CaviGuard®) will be placed on the affected area 3)The affected area should be immediately covered with 20 microliters of fluoride varnish 5% (CaviGuard®) 4)Repeat steps 1-3 one or two more times for large caries at intervals of at least 2 days apart 5)Follow up evaluation of treatment success visits will be conducted at 6 and 12 months from the initial treatment. NOTE: This is a single intervention using the device registered as Caviguard® to apply both products (Silver diamine fluoride 38% followed by Sodium fluoride varnish 5% (®)) in sequence.

Timeline

• Start date: 2022-11-07
• Primary completion: 2023-11-15
• Completion: 2023-11-15
• First posted: 2022-12-06
• Last updated: 2023-11-18

Locations

1 site across 1 country: Bolivia