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

NCT ID: NCT05638217

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 199 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2023-11-15

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients of 4 to 12 years old eligible to received dental cavity 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.

Silver diamine fluoride 38% followed by Sodium fluoride varnish 5%

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

CaviGuard®, Silver Diamine Fluoride (SDF)

Eligibility Criteria

Inclusion Criteria

• The patient must be able to receive all necessary treatments and may be followed up for additional treatments and/or record follow-ups at each time point and for the duration of the study.
• Children within the age range mentioned above.
• Require a completed informed consent form and completed nutritional survey record for anyone who will participate in the program.
• According to the evaluation of the dentist Caries grade I and grade II
• In the case of patients with disabilities, at least one parent or legal guardian must be present at all times during the study.

Exclusion Criteria

• Patients who, after assessment, identify a pulp condition or abscess in any of the teeth, this affected piece will be excluded from receiving treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish (in these cases, the Patient Coordinator will refer to a dentist outside the study for their treatment)
• Patients with caries with grade III or grade IV
• Patients with a known allergy to any of the active ingredients ( 38% silver diamine fluoride and 5% sodium fluoride varnish)
• Patients who were unable to give their informed consent or complete the nutritional survey.
• Patients who cannot participate during the entire program (12 months).
• Patients with other oral treatments (Orthodontics).
• Patients who are not present with at least one parent or legal guardian at the time of treatment.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Privada del Valle, Sede Cochabamba

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

NODK LLC, Oregón, EE. UU.

UNKNOWN

Sponsor Role: collaborator

Food Bank Bolivia

UNKNOWN

Sponsor Role: collaborator

Universidad Mayor de San Simón

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Arce Cardozo

Associate Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathaly Campero Ferrufino, DDS

Role: PRINCIPAL_INVESTIGATOR

Private University of the Valley

Ximena Claros Martinez, DDS

Role: PRINCIPAL_INVESTIGATOR

Private University of the Valley

Edwin Guarayo Molina, DDS

Role: PRINCIPAL_INVESTIGATOR

Private University of the Valley

Rodrigo k Arce Cardozo, MD, MPH,

Role: PRINCIPAL_INVESTIGATOR

Universidad Mayor de San Simon

Steve Duffin, DDS

Role: PRINCIPAL_INVESTIGATOR

NODK LLC

Locations

Bolivian Food Bank Foundation

Cochabamba, , Bolivia

Countries

Bolivia

Related Links

https://caviguard.com/

Description Intervention

http://www.univalle.edu/

Private University of the Valley

Other Identifiers

DINV-CAV01-EC001

Identifier Type: -

Identifier Source: org_study_id