Silver Diamine Fluoride for Caries in Primary Teeth in Routine Clinical Practice
Dental Caries
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- No especificado - 14 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 101 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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
Población del estudio
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.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
Children treated with silver diamine fluoride (SDF)
Children aged 14 years or younger with caries in primary teeth and an indication for SDF according to the Catalan Health Department guideline
Drug: Silver diamine fluoride 38%
Silver diamine fluoride 38% DRUG
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Proportion of treated caries lesions without progression
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Baix a Mar Integrated Primary Care CenterVilanova i la Geltrú, Barcelona, SpainReclutando
Equipo y fechas
- Patrocinador principal
- Consorci Sanitari de l'Alt Penedès i Garraf
- Inicio del estudio
- 17 sept 2026 Real
- Finalización primaria
- 31 dic 2028 Estimado
- Finalización del estudio
- 31 dic 2028 Estimado
- Primera publicación
- 9 nov 2026 Real
- Última actualización
- 9 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Efficacy and Safety of Silver Diamine Fluoride in Clinical Practice for the Treatment of Caries in Children With Primary Dentition
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 9 nov 2026