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EFFICACY OF 38% SILVER DIAMINE FLUORIDE FOR ARRESTING CARIES IN PERMANENT MOLARS OF CHILDREN AND ADOLESCENTS: A RANDOMIZED CLINICAL TRIAL

EFFICACY OF 38% SILVER DIAMINE FLUORIDE FOR ARRESTING CARIES IN PERMANENT MOLARS OF CHILDREN AND ADOLESCENTS: A RANDOMIZED CLINICAL TRIAL

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250321003
Enrollment
536
Registered
2025-03-21
Start date
2025-01-27
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated dental caries, which are cavitated dentin carious lesions in the permanent molars of children and adolescents without a history of pulpal infection, are studied for arrest rates using silver diamine fluoride. are healthy and cooperative during dental procedures and have written consent from parents and verbal consent from participants. The study will be performed in permanent molars that have untreated dentine carious lesions, ICDAS 5 or ICDAS 6. Silver diamine fluoride, 38% Silve

Interventions

38% Silver Diamine Fluoride (SDF) is a topical antimicrobial and remineralizing agent which was cleared by the FDA as a Class II medical device to treat tooth sensitivity. In certain circumstances, SD
Active Comparator Drug,Active Comparator Drug
1 minute of 38% Silver diamine fluoride application,3 minutes of 38% Silver diamine fluoride application

Sponsors

Faculty of Dentistry, Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 15 Years

Inclusion criteria

Inclusion criteria: Participant inclusion criteria: 1. Patients should be from kindergarten 3 to grade 7 in secondary school. 2. Patients should have caries lesions in at least one untreated permanent molar. 3. Patients should be in good health. 4. Patients should be cooperative during dental procedures. 5. Patients should have written consent from their parents or guardians. 6. Patients should provide verbal consent. Teeth inclusion criteria: 1. The teeth should be permanent molars. 2. The teeth should have untreated caries lesions. 3. The teeth should have ICDAS 5 or ICDAS 6 caries lesions.

Exclusion criteria

Exclusion criteria: Participant exclusion criteria: 1. Patients who have a systemic disease. 2. Patients who are taking any medications. 3. Patients who are allergic to silver. Teeth exclusion criteria: 1. Teeth that show symptoms indicating cavity penetration, swelling, abscess, or fistula. 2. Teeth with a history of spontaneous tooth pain. 3. Teeth with mobility. 4. Teeth with dental abnormalities such as fluorosis, molar incisor hypoplasia, amelogenesis imperfecta, enamel hypoplasia, dentinogenesis imperfecta, or dentinal dysplasia.

Design outcomes

Primary

MeasureTime frame
Arrested caries 3, 6, 12, 18 and 24 months after the first application Arrested rate

Secondary

MeasureTime frame
Factors affect caries arrested rate 3, 6, 12, 18 and 24 months after the first application Questionnaire, examination and statistical analysis

Countries

Thailand

Contacts

Public ContactChanakan Nuntacharoen

Faculty of Dentistry, Chulalongkorn University

Chanakan.nun@mfu.ac.th0818843011

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026