The effect of antimicrobial photodynamic therapy on infected dentin in primary teeth: A randomized controlled clinical trial protocol.

Background: Antimicrobial photodynamic therapy (aPDT) has been used for the treatment of dental caries. Papacarie is a gel composed of papain and chloramine employed for the partial removal of carious tissue, effective against bacteria, however, some studies report that this antibacterial action is not quite so evident. The aim of this study is to evaluate the clinical effect of aPDT on infected dentin in dental caries lesion in primary teeth. Methods: Thirty-two primary molars with deep occlusal dental caries will be selected and divided in 2 groups: G1 - caries removal with a low-speed drill and G2 - application of aPDT with PapacarieMBlue. After treatment, all the teeth will be restored with glass ionomer cement and followed up clinically and radiographically, with evaluations at 3, 6, and 12 months. Dentin samples before and after treatment will be analyzed microbiologically. The data will be submitted to descriptive statistical analysis of the association between the categorical variables and both age and gender using the chi-square test and Fisher exact text. The Student t test and analysis of variance will be used for the comparison of mean signs and symptoms of reversible pulpitis. Pearson correlation coefficients will be calculated for the analysis of correlations among the continuous variables. Discussion: Adding methylene blue dye to the formula of PapacarieMBlue might potentiate the antimicrobial action of aPDT and work more effectively on the infected dentin combined with a conservative, minimally invasive treatment. Trial registration: NCT02734420 on 10 march 2016.