Silver Diamine Fluoride for Caries in Primary Teeth in Routine Clinical Practice (ESFLUOR)
Efficacy and Safety of Silver Diamine Fluoride in Clinical Practice for the Treatment of Caries in Children With Primary Dentition
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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Noemí Casaponsa
- Puhelinnumero: 43197 0034938960025
- Sähköposti: recerca@csapg.cat
Opiskelupaikat
-
-
Barcelona
-
Vilanova i la Geltrú, Barcelona, Espanja
- Rekrytointi
- Baix a Mar Integrated Primary Care Center
-
Ottaa yhteyttä:
- Noemí Casaponsa
- Puhelinnumero: 43197 0034938960025
- Sähköposti: recerca@csapg.cat
-
Päätutkija:
- Nerea Cáceres
-
Päätutkija:
- Paula Batista
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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.
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
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 |
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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Proportion of treated caries lesions without progression
Aikaikkuna: 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. |
12 months after SDF application
|
Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- CSAPG-86
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
IPD-jaon aikakehys
After publication of main results of the study.
IPD-jaon käyttöoikeuskriteerit
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .