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

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

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.

Sponsors & Collaborators

• Universidad Privada del Valle, Sede Cochabamba

  collaborator UNKNOWN

• Industria Química Farmacéutica SIGMA CORP S.R.L. Cochabamba, Bolivia

  collaborator UNKNOWN

• NODK LLC, Oregón, EE. UU.

  collaborator UNKNOWN

• Food Bank Bolivia

  collaborator UNKNOWN

• Universidad Mayor de San Simón

  lead OTHER

Principal Investigators

• 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

• Steve Duffin, DDS · NODK LLC

Eligibility

Min Age

4 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-07

Primary Completion

2023-11-15

Completion

2023-11-15

Countries

• Bolivia

Study Locations