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1.
Trials ; 15: 448, 2014 Nov 19.
Article in English | MEDLINE | ID: mdl-25409545

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/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. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01477385), Initial release: 11/16/2011: last update: 06/02/2014.


Subject(s)
Dental Atraumatic Restorative Treatment/methods , Dental Caries/prevention & control , Fluorides, Topical/administration & dosage , Pit and Fissure Sealants/therapeutic use , Quaternary Ammonium Compounds/administration & dosage , Research Design , Adolescent , Brazil , Child , Child, Preschool , Clinical Protocols , Cost-Benefit Analysis , Dental Atraumatic Restorative Treatment/economics , Dental Caries/diagnosis , Dental Caries/economics , Dental Devices, Home Care , Double-Blind Method , Female , Fluorides, Topical/adverse effects , Fluorides, Topical/economics , Health Care Costs , Humans , Male , Patient Satisfaction , Pit and Fissure Sealants/adverse effects , Pit and Fissure Sealants/economics , Quaternary Ammonium Compounds/adverse effects , Quaternary Ammonium Compounds/economics , Resins, Synthetic/therapeutic use , Silver Compounds , Time Factors , Treatment Outcome
2.
Int J Paediatr Dent ; 23(2): 138-44, 2013 Mar.
Article in English | MEDLINE | ID: mdl-22512546

ABSTRACT

BACKGROUND: Individual calibration (IC) for caries detection methods based on fluorescence is time-consuming, especially for paediatric dentists, if the calibration has to be performed tooth-by-tooth. However, it is not clear how this calibration actually interfere in laser fluorescence (LF) readings. AIM: This in vivo study was to verify the influence of different modes of IC on laser fluorescence (LF) readings. DESIGN: Ninety six occlusal and 95 buccal surfaces of 1st permanent molars were examined using LF device after IC performed on control (no IC), the examined teeth, a permanent incisor, a 1st primary molar or a 2nd primary molar. All modes of IC were performed in the same child. Wilcoxon test and Bland-Altman analysis were used to compare the readings. Intraclass correlation coefficients (ICC) were calculated. RESULTS: Laser fluorescence readings without prior calibration were higher than readings performed after any mode of IC and resulted in different values of ICC. After other IC modes, the LF readings were statistically similar. CONCLUSION: The absence of IC influences LF readings and LF reproducibility, but different IC methods can be considered in clinical practice.


Subject(s)
Dental Caries/diagnosis , Lasers , Observer Variation , Brazil , Calibration/standards , Child , Child, Preschool , Data Interpretation, Statistical , Fluorescence , Humans , Statistics, Nonparametric , Time Factors
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