title: New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT01477385), Initial release: 11/16/2011: last update: 06/02/2014.
authors.forename: Juliana
authors.initials: J
authors.lastname: Mattos-Silveira
authors.forename: Isabela
authors.initials: I
authors.lastname: Floriano
authors.forename: Fernanda R
authors.initials: FR
authors.lastname: Ferreira
authors.forename: Maria E F
authors.initials: ME
authors.lastname: Viganó
authors.forename: M A
authors.initials: MA
authors.lastname: Frizzo
authors.forename: Alessandra
authors.initials: A
authors.lastname: Reyes
authors.forename: Tatiane F
authors.initials: TF
authors.lastname: Novaes
authors.forename: Caroline M
authors.initials: CM
authors.lastname: Moriyama
authors.forename: Daniela P
authors.initials: DP
authors.lastname: Raggio
authors.forename: José C P
authors.initials: JC
authors.lastname: Imparato
authors.forename: Fausto M
authors.initials: FM
authors.lastname: Mendes
authors.affiliation: Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, Av, Lineu Prestes, 2227, São Paulo, SP 05508-000, Brazil. mmbraga@usp.br.
authors.forename: Mariana M
authors.initials: MM
authors.lastname: Braga
mesh_terms: D000293:Adolescent; D001938:Brazil; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D057087:Dental Atraumatic Restorative Treatment / Q000191:economics / Q000379:methods*; D003731:Dental Caries / Q000175:diagnosis / Q000191:economics / Q000517:prevention & control*; D003742:Dental Devices, Home Care; D004311:Double-Blind Method; D005260:Female; D005460:Fluorides, Topical / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D017048:Health Care Costs; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D010895:Pit and Fissure Sealants / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D000644:Quaternary Ammonium Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D012107:Research Design; D012117:Resins, Synthetic / Q000627:therapeutic use; D018030:Silver Compounds; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005460:Fluorides, Topical; D010895:Pit and Fissure Sealants; D000644:Quaternary Ammonium Compounds; D012117:Resins, Synthetic; D018030:Silver Compounds; C024633:silver diamine fluoride