NCT07926828 Silver Diamine Fluoride for Caries in Primary Teeth in Routine Clinical Practice
| NCT ID | NCT07926828 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf |
| Condition | Dental Caries |
| Study Type | OBSERVATIONAL |
| Enrollment | 101 participants |
| Start Date | 2026-09-17 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 101 participants in total. It began in 2026-09-17 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07926828 clinical trial?
This trial is open to participants of all sexes, up to 14 Years, studying Dental Caries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07926828 currently recruiting?
Yes, NCT07926828 is actively recruiting participants. Contact the research team at recerca@csapg.cat for enrollment information.
Where is the NCT07926828 trial being conducted?
This trial is being conducted at Vilanova i la Geltrú, Spain.
Who is sponsoring the NCT07926828 clinical trial?
NCT07926828 is sponsored by Consorci Sanitari de l'Alt Penedès i Garraf. The trial plans to enroll 101 participants.