NCT07153328: SDF-FV

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

Completed NA Last updated 3 September 2025

What this trial tests

NA trial testing Silver Diamine Fluoride (SDF, 38%) and Sodium Fluoride Varnish (NaF, 5%) in Dental Caries in 104 participants. Completed in 25 March 2024.

Timeline

7 January 2021

Primary endpoint
25 March 2024

25 March 2024

Quick facts

Lead sponsor	Beaty Dent
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	104
Start date	7 January 2021
Primary completion	25 March 2024
Estimated completion	25 March 2024
Sites	2 locations across Albania

Drugs / interventions tested

• Silver Diamine Fluoride (SDF, 38%) and Sodium Fluoride Varnish (NaF, 5%) — full drug profile →
• Silver Diamine Fluoride (SDF, 38%) — full drug profile →

Conditions studied

• Dental Caries — all drugs for Dental Caries →

Sponsor

Beaty Dent — full company profile →

Who can join

Adults 18 Months to 8, any sex, with Dental Caries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Tooth decay (dental caries) occurs when acids dissolve tooth structure. If not treated, cavities in primary teeth can progress quickly, leading to caries, infection and early tooth loss. These problems may affect chewing, speech, nutrition, and overall health. In Albania and many other countries, cavities in young children are very common. Standard dental treatments are often difficult in very young or uncooperative children and may require sedation or general anesthesia.

Silver diamine fluoride (SDF) is a liquid medication that can be painted directly onto cavities. SDF stops cavities from worsening by killing bacteria and hardening softened tooth surfaces. The main side effect is dark staining of the treated area. Despite this, SDF is considered safe and effective, especially for children who cannot tolerate conventional treatment. Fluoride varnish (FV) is another preventive treatment applied to all tooth surfaces to strengthen enamel and help prevent new cavities.

The purpose of this study is to compare two approaches for managing tooth decay in young children who have difficulty cooperating for dental care:

* SDF applied to cavities every six months.
* SDF applied every six months, with FV applied to all teeth every three months. A total of 104 children between the ages of 1.5 and 8 years with active cavities in their primary (baby) teeth were enrolled. Children were randomly assigned to one of the two treatment groups.

The children were followed for 24 months. The main outcome measured is whether cavities became arrested, meaning the surface became hard and inactive with no further breakdown. Additional outcomes include whether combining SDF with FV provides added benefit and whether baseline factors such as oral hygiene and diet influence treatment success.

The information from this study may help dentists and parents understand how SDF, with or without FV, can be used as a safe, effective, and child-friendly option to manage cavities in young children.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Silver Diamine Fluoride in Arresting Dental Caries Among Young Children: a Randomized Clinical Trial.
   Kelmendi M, Robo I, Petro E, Kelmendi S. · · 2025 · PMID 41282046 · DOI 10.5455/medarh.2025.79.399-405