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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial

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Mattos-Silveira, Juliana [1] ; Floriano, Isabela [1] ; Ferreira, Fernanda R. [1] ; Vigano, Maria E. F. [1] ; Frizzo, M. A. [1] ; Reyes, Alessandra [1] ; Novaes, Tatiane F. [1] ; Moriyama, Caroline M. [1] ; Raggio, Daniela P. [1] ; Imparato, Jose C. P. [1] ; Mendes, Fausto M. [1] ; Braga, Mariana M. [1]
Total Authors: 12
[1] Univ Sao Paulo, Dept Pediat Dent, Sch Dent, BR-05508000 Sao Paulo - Brazil
Total Affiliations: 1
Document type: Journal article
Source: Trials; v. 15, NOV 19 2014.
Web of Science Citations: 6

Background: Approximal surfaces are a challenge to caries lesions control. Silver diamine fluoride (SDF) is a simple, low-cost and promisor intervention for arresting caries lesions, but it has never been tested on approximal surfaces. Our aim is to evaluate the efficacy and cost-efficacy of SDF in arresting initial lesions compared to resin infiltration and exclusively flossing (control group). Our second aim is to assess discomfort and satisfaction regarding interventions. Methods/design: This is a randomized clinical trial, double-blinded, placebo-controlled study. Children/adolescents presenting at least one approximal initial caries lesion in primary molars/permanent premolars and molars will be included. Surfaces with advanced dentine lesions identified by radiography and participants who refuse to participate or present negative behaviors will be excluded. A minimum sample size of 504 surfaces will be required for each subgroup. Individuals will be randomly allocated in three groups of interventions: SDF, resin infiltration, and control group. Depending on the allocation, the patients will receive the active treatment and respective placebo therapies. All patients will be oriented to daily flossing the included surfaces. Our primary outcome will be caries progression by clinical and radiographic examinations. Appointments will be timed and costs of materials will be considered to calculate cost-efficacy. Patient discomfort will be assessed after interventions. Parent and patient satisfaction with the treatment will be collected after treatment and in the last follow-up visit. Individuals will be assessed at 1 and 3 months after treatment to evaluate dental biofilm and at 6, 12, and 24 months to assess caries progression by visual examination and/or radiography. Multilevel analyses will be used to verify if the type of treatment influenced on the tested outcomes. Costs will be compared and analyses of cost-efficacy will be performed. Poisson analysis will test the association between intervention and reported discomfort and satisfaction. Discussion: Our hypothesis is that SDF is the most cost-efficacious option from all tested interventions. If our hypothesis is confirmed, the use of SDF in private and public contexts could represent an easier and effective option in the treatment of enamel approximal caries in children/adolescents. (AU)

FAPESP's process: 12/50716-0 - Cost-efectiveness, children's and parental acceptability of using diammine silver fluoride in arresting enamel caries lesions: a series of randomized clinical trials
Grantee:Mariana Minatel Braga
Support type: Regular Research Grants
FAPESP's process: 14/00271-7 - Cost-efficacy and adolescents' acceptability in treating initial approximal caries lesions using diammine silver fluoride: a randomized controlled clinical trial
Grantee:Fernanda Rosche Ferreira
Support type: Scholarships in Brazil - Master