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

Universidad Mayor de San Simón

Status: Completed

Conditions: Dental Caries in Children

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

Study type: Observational

Funder types: Other

Identifiers

NCT05638217

DINV-CAV01-EC001

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

199 participants in 1 patient group

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

Description:

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.

Treatment:

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