Abstract
BackgroundAlthough 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/DesignTo 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.DiscussionOur 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.Trial registrationNCT02078453. Registered 4 March 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1196-5) contains supplementary material, which is available to authorized users.
Highlights
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
Our working hypothesis is that radiographic examination would exert little influence on patient-centered outcomes, and visual inspection would be enough as diagnostic strategy for caries detection in primary teeth
The method has not presented high sensitivity in detecting caries lesions, mainly at proximal surfaces [2]. To overcome this limitation of the visual inspection, many clinical guidelines used throughout the world have advised that dentists take two bilateral bitewing radiographs in children to detect missed caries lesions in primary molars [5,6,7]
Summary
We expect this study to provide the best scientific evidence for defining better diagnostic strategies for use in detecting caries in primary teeth. Randomized clinical trials evaluating relevant outcomes for patients (Phase 4 questions) represent a higher degree of evidence in diagnostic research. This type of study is conducted to evaluate if patients who undergo a diagnostic method fare better than untested patients [34]. Considering the problems of unnecessary treatment due to false-positive results, stress caused by the diagnosis of women who do not die from this disease (correct and incorrect diagnoses) and other problems, the risks outweigh the benefits of mammography in this age group [41] This type of results can be only evaluated in randomized clinical trials because the validity studies do not deal with this aspect. Juan Sebastian Lara, Judith Liberman Perlmuter, Julia Gomes Freitas, Júlia Maria Ribeiro Fonseca, Kianne Santos Chaves, Laura Regina Antunes Pontes, Laysa Yoshioka, Leticia Tiemi Hashizume, Ligia Akemi, Lucas Botelho Gazzinelli, Lucila Basto Camargo, Marcelo Bonecker, Marcia Turolla Wanderley, Maria Salete Nahás Pires Corrêa, Mariana Minatel Braga, Michele Baffi Diniz, Pamela Rocha Lopes de Almeida, Renata Marques Samuel, Renata Saraiva Guedes, Sergio Marcelino Covos, Simone Cesar, Tamara Kerber Tedesco, Tatiane Fernandes Novaes, Thais Gimenez and Thiago Machado Ardenghi
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