Silver Diamine Fluoride for Caries in Primary Teeth in Routine Clinical Practice (ESFLUOR)

Dental caries is one of the most common chronic diseases in childhood and remains a public health problem, especially in primary teeth and in children from lower socioeconomic backgrounds attended in the public health system. Topical 38% silver diamine fluoride (SDF) is a minimally invasive treatment that arrests caries progression, with arrest rates above 70% in controlled trials. However, there is little evidence on its effectiveness and safety in routine clinical practice, particularly with current formulations that use water instead of ammonia as the vehicle and include potassium iodide to reduce staining.

This is a single-cohort prospective study conducted at the Dentistry Service of the Baix a Mar Integrated Primary Care Center (Consorci Sanitari de l'Alt Penedès i Garraf). Children with caries in primary teeth who have an indication for SDF according to the Catalan Health Department guideline "Implementation of silver diamine fluoride treatment in primary and community care dental clinics: rationale and protocol for use" will be invited to participate. SDF 38% (Riva Star) will be applied according to that guideline. Participants will be assessed at baseline and at 1, 6, and 12 months. At each follow-up, the investigator will rate caries progression (yes/no) based on visual appearance (dark, shiny, smooth surface), tactile assessment with a dental probe (hard, smooth, not sticky), absence of symptoms, stability over time, and radiographs if needed.

The primary analysis will estimate the proportion of treated lesions without progression at 12 months with its 95% confidence interval. Logistic regression will be used to explore factors associated with progression, and subgroup analyses by sex and age are planned. A sample of 101 participants allows the proportion of arrested lesions (expected around 70%) to be estimated with a precision of ±10 percentage points and 95% confidence, assuming a 20% loss to follow-up.