Evaluation of the effectiveness of photodynamic therapy for the endodontic treatment of primary teeth: study protocol for a randomized controlled clinical trial

BACKGROUND: The elimination of pathogenic microorganisms from the root canal system is one of the major steps required for successful endodontic treatment. The aim of the proposed study is to conduct a randomized, controlled, clinical trial for the clinical and radiographic evaluation of the effectiveness of photodynamic therapy during the endodontic treatment of primary teeth. METHODS: Thirty primary anterior teeth in children aged 3 to 6 years old will be randomly divided into 2 groups: a control group, which will receive conventional treatment, and an experimental group, which will be subjected to photodynamic therapy. Microbiological evaluations will be performed before and after endodontic treatment. Moreover, clinical and radiographic evaluations will be performed on the day of treatment as well as 1, 3 and 6 months after treatment. Comparisons will be made of the two study groups. The data will be tabulated and presented in a descriptive, analytical fashion. Depending on the distribution (normal or non-normal), either the t test, ANOVA or the Mann-Whitney test will be used for analysis of the variables. The Wilcoxon test will be used for comparisons before and after treatment. P values < 0.05 (95 % significance level) will be considered indicative of statistically significant differences. DISCUSSION: As successful endodontic treatment is directly related to intra-canal bacterial disinfection and consideringthe difficult task of endodontic treatment in primary teeth, often due to difficulties in controlling youngchildren, the internal anatomy of root canals and root resorption, the alternative of using PDT is a painless,easy-to-administer method that does not lead to microbial resistance and can assist in the achievement ofsuccessful endodontic treatment in primary teeth by eliminating the pain children can experience due to retreatmentas well as premature tooth loss. TRIAL REGISTRATION: The protocol for this study was registered with Clinical Trials number NCT02485210 on 30 july 2015.