Silver Diamine Fluoride for Caries in Primary Teeth in Routine Clinical Practice

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

Not specified - 14 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

101 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The goal of this observational study is to learn how well and how safely silver diamine fluoride (SDF) stops tooth decay (caries) in baby teeth when it is used in routine dental care. It will include children aged 14 years or younger with caries in their primary (baby) teeth who are treated with SDF at a public primary care dental clinic. The main questions it aims to answer are:

• What proportion of caries lesions treated with SDF do not progress after 12 months?
• How often do side effects occur, such as black staining of the tooth, sensitivity, abscesses, gum or skin irritation, or allergy?
• How satisfied are parents with the treatment? Participants will receive SDF as part of their usual dental care and will attend check-up visits 1, 6, and 12 months after treatment, where the dentist will examine the treated teeth, assess oral hygiene, and ask about diet and any side effects. Parents will answer a short satisfaction questionnaire.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Boys and girls aged 14 years or younger
• Caries in primary teeth with an indication for SDF treatment according to section 4 of the Catalan Health Department guideline "Implementation of silver diamine fluoride treatment in primary and community care dental clinics: rationale and protocol for use"
• Signed informed consent from the parent or legal representative
• For participants aged 12 years or older, signed informed assent adapted to their level of understanding, in addition to the consent of their legal representatives

Exclusion Criteria:

• Spontaneous or provoked pain associated with the caries lesion
• Deep caries lesion close to the dental pulp, according to the investigator's judgment
• Objection by the parents or the child to the black staining caused by SDF
• Irreversible pulpitis or pulp necrosis
• Active oral ulcers or gingivostomatitis
• History of allergy to silver, ammonia, or iodine
• Participation in another study involving an experimental intervention during the period of this study and/or with a visit schedule incompatible with this study

Study population

Children aged 14 years or younger attended at the Dentistry Service of the Baix a Mar Integrated Primary Care Center who have caries in primary teeth with an indication for SDF treatment. All consecutive eligible children whose legal representatives agree to participate will be included.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Study start

Sep 17, 2026 Actual

Primary completion

Dec 31, 2028 Estimated

Study completion

Dec 31, 2028 Estimated

First posted

Nov 9, 2026 Actual

Last updated

Nov 9, 2026 Actual

Official study contacts