title: Impact of the radiographic examination on diagnosis and treatment decision of caries lesions in primary teeth--the Caries Detection in Children (CARDEC-01) trial: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Although most clinical guidelines throughout the world indicate that clinicians take two bitewings for detecting caries lesions in primary molars of all children, evidence for this recommendation is essentially based on cross-sectional studies performed in laboratory settings or using convenience samples. The benefits and impact of performing radiographs on diagnosis and treatment decision of caries lesions in primary teeth, mainly considering relevant outcomes for patients, have not been evaluated yet. Thus, the aim of this randomized clinical trial will be to evaluate the impact of performing radiographic examination adjunct to the visual inspection for detecting and making treatment decision regarding caries lesions in primary teeth compared with visual inspection performed alone. We will consider different outcomes related to children's health and welfare.
  
  
  METHODS
  To reach this objective, 250 children ages 3 to 6 years who sought dental treatment in our dental school will be randomly allocated in two groups according to the diagnostic strategy used for caries detection: visual inspection performed alone or visual inspection associated to radiographic examination. Two trained and calibrated examiners will carry out the examinations and elaborate the treatment decision plan. Then, children will be treated and followed up for 2 years, with evaluations after 12 and 24 months after the inclusion of children in the study. Children will also return after 6 and 18 months to reinforce the preventive orientations. Primary outcome will be the number of dental surfaces in need of dental treatment at the follow-up. Secondary outcomes will be the components of the primary outcome separately, as well as, proportion of false-positive results, the oral health-related quality of life, cost-efficacy, cost-adjusted life years, and number of new lesions in the first permanent molars.
  
  
  CONCLUSIONS
  Our working hypothesis is that radiographic examination would actually exert little influence on patient-centered outcomes, and visual inspection would be enough as diagnostic strategy for caries detection in primary teeth.
  
  
  BACKGROUND
  NCT02078453. Registered 4 March 2015.
authors: Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. fmmendes@usp.br.
authors: Fausto Medeiros
authors: FM
authors: Mendes
authors: Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. laura.pontes@usp.br.
authors: Laura Regina Antunes
authors: LR
authors: Pontes
authors: Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. thais.gimenez@usp.br.
authors: Thais
authors: T
authors: Gimenez
authors: Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. juanslara@usp.br.
authors: Juan Sebastian
authors: JS
authors: Lara
authors: Department of Pediatric Dentistry, Universidade Paulista, São Paulo, Brazil. lucilaca@usp.br.
authors: Lucila Basto
authors: LB
authors: de Camargo
authors: Departament of Community Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. michelcrosato@usp.br.
authors: Edgard
authors: E
authors: Michel-Crosato
authors: Division of Periodontics, School of Dentistry, University of São Paulo, São Paulo, Brazil. cmpannuti@gmail.com.
authors: Claudio Mendes
authors: CM
authors: Pannuti
authors: Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. danielar@usp.br.
authors: Daniela Prócida
authors: DP
authors: Raggio
authors: Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. mmbraga@usp.br.
authors: Mariana Minatel
authors: MM
authors: Braga
authors: Instituto de Odontologia, Universidade Cruzeiro do Sul, São Paulo, Brazil. tatifn@globo.com.
authors: Tatiane Fernandes
authors: TF
authors: Novaes
mesh_terms: D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D003731:Dental Caries / Q000000981:diagnostic imaging* / Q000628:therapy; D005500:Follow-Up Studies; D006801:Humans; D017063:Outcome Assessment, Health Care; D018401:Sample Size