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

Abstract

BackgroundApproximal 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/designThis 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.DiscussionOur 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.Trial registrationClinicalTrials.gov (NCT01477385), Initial release: 11/16/2011: last update: 06/02/2014.Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-448) contains supplementary material, which is available to authorized users.

Are the Approximal Caries Lesions in Primary Teeth a Challenge to Deal With? — A Critical Appraisal of Recent Evidences in This Field

“…Staining caused by inactivation of caries lesions and/or using of SDF has not been systematically assessed. That is one of our concerns when testing the SDF as a possibility to treat initial caries [67]. Based on some preliminary findings, we believe this consequence of the mentioned treatment will not impact on patient's and parent's perceptions, especially due to the position of the surface, which hides the effect of SDF application (see Figure 23).…”

“…Another option tested for the same purpose was an association AgF followed by SnF2, resulting in a arrestment of 74% of approximal caries lesions [46]. At the moment, our group is testing Emerging Trends in Oral Health Sciences and Dentistry the use of the silver diamine fluoride (SDF) to control approximal caries in primary teeth [67] ( Figure 22 and 23). A previous study of our group pointed to the possibility of using the silver diamine fluoride (SDF) in children for arrestment of enamel caries lesions on occlusal surfaces of permanent erupting molar [68].…”

Pediatric Dental-Focused Interprofessional Interventions

“…Application of effective agents is also cost-effective relative to repair as they prevent caries progression in high risk children at low cost. 2526 With further study through randomized controlled trials now underway, 2728 evidence of effectiveness for arresting agents is likely to catch up with pediatric dental educators' enthusiasm for them. 29 …”

Custo-eficácia do diamino fluoreto de prata a 30% no controle da progressão de lesões de cárie em esmalte na oclusão de molares em erupção: estudo clínico controlado e radomizado

“…Isso pode ocorrer devido à própria composição do produto a ser avaliado. O DFP, por exemplo, é uma substância que vem sendo testada em alguns estudos de eficácia, comparado a um produto placebo (12,25).…”

“…Usualmente, o tratamento placebo utilizado nesses casos tem sido a simulação de todos os passos clínicos e ao invés do componente ativo, aplicação de água (12,25). Acredita-se, que isso poderia impactar, por outro lado, na aceitabilidade do produto pelo paciente, em função do gosto diferente, já que o DFP tem um gosto metálico (30) em função da sua composição.…”