SDF With or Without Fluoride Varnish for Caries Arrest in Primary Teeth of Young Children

NACompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

January 7, 2021

Primary Completion Date

March 25, 2024

Study Completion Date

March 25, 2024

Conditions
Dental Caries
Interventions
DRUG

Silver Diamine Fluoride (SDF, 38%) and Sodium Fluoride Varnish (NaF, 5%)

Application of 38% silver diamine fluoride (SDF) to all active carious lesions at baseline and every 6 months (months 0, 6, 12, and 18, 24). In addition, a 5% sodium fluoride varnish (NaF) is applied to all teeth at 3-month intervals (months 3, 9, 15, 21). Applications are performed by a dentist using standard microbrush or applicator techniques, ensuring lesions coverage for SDF and full dentition coverage for NaF varnish. This alternating protocol evaluates whether combining periodic SDF with regular fluoride varnish enhances caries arrest in primary teeth compared to semiannual SDF alone.

DRUG

Silver Diamine Fluoride (SDF, 38%)

Application of 38% silver diamine fluoride (SDF) to all active carious lesions at baseline and every 6 months (months 0, 6, 12, and 18, 24). Applications are performed by a dentist using a microbrush to directly cover the lesion surface until fully saturated. No additional fluoride varnish is provided in this arm. The protocol evaluates the effectiveness of semiannual SDF application alone for arresting active caries in primary teeth of young, uncooperative pediatric patients.

Trial Locations (2)

1001

Beaty Dent, Tirana

Happy Dent, Tirana

All Listed Sponsors
lead

Beaty Dent

OTHER

NCT07153328 - SDF With or Without Fluoride Varnish for Caries Arrest in Primary Teeth of Young Children | Biotech Hunter | Biotech Hunter