title: Evaluation of the effectiveness of photodynamic therapy for the endodontic treatment of primary teeth: study protocol for a randomized controlled clinical trial.
abstract: 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.
  
  
  CONCLUSIONS
  As successful endodontic treatment is directly related to intra-canal bacterial disinfection and considering the difficult task of endodontic treatment in primary teeth, often due to difficulties in controlling young children, 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 of successful endodontic treatment in primary teeth by eliminating the pain children can experience due to retreatment as well as premature tooth loss.
  
  
  BACKGROUND
  The protocol for this study was registered with Clinical Trials number NCT02485210 on 30 july 2015.
authors.affiliation: Biofotonics Applied to Science Health Post Graduation Program Nove de Julho University, Rua Vergueiro, 249 - Liberdade CEP 0154001, São Paulo, SP, Brasil. ana_cmota@yahoo.com.br.
authors.forename: Ana Carolina Costa
authors.initials: AC
authors.lastname: da Mota
authors.affiliation: Biofotonics Applied to Science Health Post Graduation Program Nove de Julho University, Rua Vergueiro, 249 - Liberdade CEP 0154001, São Paulo, SP, Brasil. marcelalleal@hotmail.com.
authors.forename: Marcela Leticia Leal
authors.initials: ML
authors.lastname: Gonçalves
authors.affiliation: Biofotonics Applied to Science Health Post Graduation Program Nove de Julho University, Rua Vergueiro, 249 - Liberdade CEP 0154001, São Paulo, SP, Brasil. carolbortoletto@ig.com.br.
authors.forename: Carolina
authors.initials: C
authors.lastname: Bortoletto
authors.affiliation: Biofotonics Applied to Science Health Post Graduation Program Nove de Julho University, Rua Vergueiro, 249 - Liberdade CEP 0154001, São Paulo, SP, Brasil. silviaolivan@uninove.br.
authors.forename: Silvia Regina
authors.initials: SR
authors.lastname: Olivan
authors.affiliation: Biofotonics Applied to Science Health Post Graduation Program Nove de Julho University, Rua Vergueiro, 249 - Liberdade CEP 0154001, São Paulo, SP, Brasil. monicasalgueiro@globo.com.
authors.forename: Monica
authors.initials: M
authors.lastname: Salgueiro
authors.affiliation: Biofotonics Applied to Science Health Post Graduation Program Nove de Julho University, Rua Vergueiro, 249 - Liberdade CEP 0154001, São Paulo, SP, Brasil. cami_godoy@hotmail.com.
authors.forename: Camila
authors.initials: C
authors.lastname: Godoy
authors.affiliation: Biofotonics Applied to Science Health Post Graduation Program Nove de Julho University, Rua Vergueiro, 249 - Liberdade CEP 0154001, São Paulo, SP, Brasil. altavista.ii@gmail.com.
authors.forename: Olga Maria
authors.initials: OM
authors.lastname: Altavista
authors.affiliation: Biofotonics Applied to Science Health Post Graduation Program Nove de Julho University, Rua Vergueiro, 249 - Liberdade CEP 0154001, São Paulo, SP, Brasil. mmpdent@hotmail.com.
authors.forename: Marcelo Mendes
authors.initials: MM
authors.lastname: Pinto
authors.affiliation: Biofotonics Applied to Science Health Post Graduation Program Nove de Julho University, Rua Vergueiro, 249 - Liberdade CEP 0154001, São Paulo, SP, Brasil. annacrth@gmail.com.
authors.forename: Anna Carolina
authors.initials: AC
authors.lastname: Horliana
authors.affiliation: Biofotonics Applied to Science Health Post Graduation Program Nove de Julho University, Rua Vergueiro, 249 - Liberdade CEP 0154001, São Paulo, SP, Brasil. larajmotta@terra.com.br.
authors.forename: Lara J
authors.initials: LJ
authors.lastname: Motta
authors.affiliation: Biofotonics Applied to Science Health Post Graduation Program Nove de Julho University, Rua Vergueiro, 249 - Liberdade CEP 0154001, São Paulo, SP, Brasil. Sandra.skb@gmail.com.
authors.forename: Sandra Kalil
authors.initials: SK
authors.lastname: Bussadori
mesh_terms: D000704:Analysis of Variance; D001938:Brazil; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D019140:Dental Care for Children / Q000379:methods*; D003786:Dental Pulp Cavity / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000382:microbiology; D005260:Female; D006801:Humans; D008297:Male; D008751:Methylene Blue / Q000009:adverse effects / Q000627:therapeutic use*; D010485:Periapical Periodontitis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000382:microbiology; D010778:Photochemotherapy / Q000009:adverse effects; D017319:Photosensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011859:Radiography; D012107:Research Design; D012390:Root Canal Therapy / Q000009:adverse effects / Q000379:methods*; D018709:Statistics, Nonparametric; D013997:Time Factors; D014094:Tooth, Deciduous / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000382:microbiology; D016896:Treatment Outcome
chemical_list: D017319:Photosensitizing Agents; D008751:Methylene Blue