Clinical trial NCT05638217: Efficacy of the Use of Silver Diamine Fluoride and Sodium Fluoride Varnish for the Treatment of Caries in Children
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries in Children
Keywords: Oral Health
Dental Caries
Silver Diamine Fluoride
Caries in Children
CaviGuard®
Lead sponsor: Universidad Mayor de San Simón
Sponsor class: OTHER
Collaborators: name: Universidad Privada del Valle, Sede Cochabamba
name: Industria Química Farmacéutica SIGMA CORP S.R.L. Cochabamba, Bolivia
name: NODK LLC, Oregón, EE. UU.
name: Food Bank Bolivia
First posted: 2022-12-06
Enrollment: 199
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Ratio of arrested cavity lesions after treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish
timeFrame: 6 months from initial treatment
measure: Ratio of arrested cavity lesions after treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish
timeFrame: 12 months from treatment
Secondary outcomes:
measure: Evaluate hardness
timeFrame: 6 months from treatment
measure: Evaluate color change
timeFrame: 6 months from treatment
measure: Evaluate cavity progression of cavity treated
timeFrame: 6 months from treatment
measure: Evaluation the reduction of oral pain caused by the presence of carious lesions.
timeFrame: 6 months from treatment
measure: Evaluate Improvement in gingival oral health.
timeFrame: 6 months from treatment
measure: Evaluate changes in height and weight
timeFrame: 6 months from treatment
measure: Evaluate changes in hemoglobin levels
timeFrame: 6 months from treatment
measure: Evaluate changes in a nutritional survey
timeFrame: 6 months from treatment
measure: Evaluate hardness
timeFrame: 12 months from initial treatment
measure: Evaluate color change
timeFrame: 12 months from initial treatment
measure: Evaluate cavity progression of cavity treated
timeFrame: 12 months from initial treatment
measure: Evaluation of the reduction of oral pain caused by the presence of carious lesions
timeFrame: 12 months from initial treatment
measure: Evaluate Improvement in gingival oral health.
timeFrame: 12 months from initial treatment
measure: Evaluate changes in height and weight
timeFrame: 12 months from treatment
measure: Evaluate changes in hemoglobin levels
timeFrame: 12 months from treatment
measure: Evaluate changes in a nutritional survey
timeFrame: 12 months from treatment
Other outcomes:
Locations:
city: Cochabamba
country: Bolivia
facility: Bolivian Food Bank Foundation
Study officials:
affiliation: Private University of the Valley
name: Nathaly Campero Ferrufino, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Private University of the Valley
name: Ximena Claros Martinez, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Private University of the Valley
name: Edwin Guarayo Molina, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Mayor de San Simon
name: Rodrigo k Arce Cardozo, MD, MPH,
role: PRINCIPAL_INVESTIGATOR
affiliation: NODK LLC
name: Steve Duffin, DDS
role: PRINCIPAL_INVESTIGATOR
References: