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

Condition(s) studied

Investigational drug(s) / intervention(s)

Silver diamine fluoride 38%: Topical application of 38% silver diamine fluoride to caries lesions in primary teeth, following section 4.3 ("Guidelines for the use of SDF in primary and community care") of the Catalan Health Department guideline, as part of routine clinical practice.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Proportion of treated caries lesions without progression — 12 months after SDF application
  Number of caries lesions without progression divided by the total number of caries lesions treated with SDF. Progression (yes/no) is rated by the investigator based on visual appearance, tactile assessment with a dental probe, absence of symptoms, stability over time, and radiographs if needed.

Trial sites (1)

More Consorci Sanitari de l'Alt Penedès i Garraf trials in Spain