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

NCT05638217 | Completed DMC

• 1 other identifier: DINV-CAV01-EC001
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

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

Keywords

Oral Health; Dental Caries; Silver Diamine Fluoride; Caries in Children; CaviGuard®

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (16)

• 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

Study Arms (1)

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.

Combination Product: Silver diamine fluoride 38% followed by Sodium fluoride varnish 5%

Interventions

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

Also known as: CaviGuard®, Silver Diamine Fluoride (SDF)

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

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Mayor de San Simón: lead
• Universidad Privada del Valle, Sede Cochabamba: collaborator
• Industria Química Farmacéutica SIGMA CORP S.R.L. Cochabamba, Bolivia: collaborator
• NODK LLC, Oregón, EE. UU.: collaborator
• Food Bank Bolivia: collaborator

Study Sites (1)

Bolivian Food Bank Foundation

Cochabamba, 00000, Bolivia

Location

Related Links

• Description Intervention
• Private University of the Valley

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Nathaly Campero Ferrufino, DDS

  Private University of the Valley

  PRINCIPAL INVESTIGATOR

• Ximena Claros Martinez, DDS

  Private University of the Valley

  PRINCIPAL INVESTIGATOR

• Edwin Guarayo Molina, DDS

  Private University of the Valley

  PRINCIPAL INVESTIGATOR

• Rodrigo k Arce Cardozo, MD, MPH,

  Universidad Mayor de San Simon

  PRINCIPAL INVESTIGATOR

• Steve Duffin, DDS

  NODK LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Professor

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 6, 2022
• Study Start: November 7, 2022
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)