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
Sponsor study identifier
observational
199
1 country
1
Study Start
November 7, 2022
Actual (reported)Primary Completion
November 15, 2023
Actual (reported)Study Completion
November 15, 2023
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2023
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 7, 2022
Actual (reported)November 10, 2022
Actual (reported)December 6, 2022
Actual (reported)November 15, 2023
Actual (reported)November 15, 2023
Actual (reported)Ratio of arrested cavity lesions after treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish
The investigators will evaluate the efficacy of treatment of active cavity lesions arrested after using the treatment protocol with 38% silver diamine fluoride and 5% sodium fluoride varnish. This evaluation will be performed by a trained dentist conducting an evaluation of multiple clinical findings including signs and symptoms of an active or arrested cavity.The clinical evaluation will be recorded in an odontograph for each patient.
6 months from initial treatment
Ratio of arrested cavity lesions after treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish
The investigators will evaluate the efficacy of treatment of active cavity lesions after using the treatment protocol with 38% silver diamine fluoride and 5% sodium fluoride varnish. This evaluation will be performed by a trained dentist conducting an evaluation of multiple clinical findings including signs and symptoms of an active or arrested cavity.The clinical evaluation will be recorded in an odontograph for each patient.
12 months from treatment
Evaluate hardness
6 months from treatment
Evaluate color change
6 months from treatment
Evaluate cavity progression of cavity treated
6 months from treatment
Evaluation the reduction of oral pain caused by the presence of carious lesions.
6 months from treatment
Evaluate Improvement in gingival oral health.
6 months from treatment
Patients of 4 to 12 years old that are eligible to received dental cavity treatment. The goal of this observational study is to identify the efficacy of silver diamine fluoride 38% followed by sodium fluoride varnish 5%, using "CaviGuard®" as delivery method, in a population with untreated dental caries age range 4 to 12 years old.
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.
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This study will be carried out in the city of Cochabamba, Bolivia, specifically at the Bolivian Food Bank Foundation located on Calle Francisco Prada between Aurelio Melean and J. Arauco 1120, from November 2022 to November 2023. This is a prospective cohort with a single assignment group (children aged 4 to 12 years) where a sample of 100-150 patients will be evaluated before, during and after their treatment.
Bolivian Food Bank Foundation
Cochabamba, 00000, Bolivia
Nathaly Campero Ferrufino, DDS
Private University of the Valley
Ximena Claros Martinez, DDS
Private University of the Valley
Edwin Guarayo Molina, DDS
Private University of the Valley
Rodrigo k Arce Cardozo, MD, MPH,
Universidad Mayor de San Simon
199 participants (actual enrollment reported by the registry).
First Submitted
November 10, 2022
First Posted
December 6, 2022
Study Start
November 7, 2022
Actual (reported)Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride
Application of SDF Verses NaF Varnish in Treatment of Carious Primary Teeth
Contact the study team to confirm eligibility.
Steve Duffin, DDS
NODK LLC
Primary Completion
November 15, 2023
Actual (reported)Study Completion
November 15, 2023
Actual (reported)Last Updated
November 18, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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