Abstract
BackgroundThe 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.MethodsThirty 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.DiscussionAs 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 registrationThe protocol for this study was registered with Clinical Trials number NCT02485210 on 30 july 2015.
Highlights
The elimination of pathogenic microorganisms from the root canal system is one of the major steps required for successful endodontic treatment
The existence of residual bacteria in many cases can lead to further infection of the root canal, which requires re-treatment or even extraction [3, 4, 6]
Based on a previous study by Pinheiro et al [7] for sample size calculation it was considered the standard desviation (2.41) and the diference to be detected in the median of colony forming units per milimiter (CFU/ml) before and after Photodynamic therapy (PDT) 2.9, with significance level of 5 % and power of 95 %
Summary
Ethical considerations The proposed study will be conducted in compliance with the regulatory norms governing research involving human subjects and has received approval from the institutional review board of University of Nove de Julho (São Paulo, Brazil) under process number 832.657. 3. Lack of repair (= failure) Clinically: signs and symptoms indicative of acute apical periodontitis; Radiographically: presence of pathological root resorption, lesion in furcation/periapical region unchanged in size during follow-up period, increase in lesion size or the development of a new lesion [17]. 9. Root canal irrigated with sterile saline solution and insertion of 3 sterile paper cones for 30 seconds for second collection of bacterial sample and immediate placement in brain heart infusion broth. Microbiological analysis All samples will be collected with three paper cones, which will be inserted into the root canal before and immediately after treatment and placed into brain heart infusion broth for culturing to allow the determination of the total number of viable bacteria. Children aged 3 to 6 years with dental caries on primary anterior teeth and endodontic involvement recruited from pediatric clinic of University Nove de Julho, São Paulo, Brazil
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