Silver Diamine Fluoride for Caries in Baby Teeth in Routine Dental Care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective single-cohort observation conducted in a public primary care dental clinic. Children with caries in their baby teeth who need SDF treatment will receive it according to local guidelines and be followed for 12 months with check-ups at 1, 6, and 12 months. Outcomes include whether caries progress stops, the frequency of side effects like staining or discomfort, and parent satisfaction. Assessments combine clinical exam findings, patient-reported information, and, when needed, radiographs. The study aims to provide real-world evidence on effectiveness and safety of current SDF formulations in routine practice.

Why it matters

Who can join: the full rules

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

Where it's running

• Baix a Mar Integrated Primary Care Center
  Vilanova i la Geltrú, Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Noemí Casaponsa
• Email: recerca@csapg.cat
• Phone: 0034938960025

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.