RESUMO
Randomised clinical trial (RCT) is the best study design to evaluate the effect of the treatment and preventive healthcare procedures. The effects of the tested treatments on patient's health are compared in terms of outcomes, which are used to evaluate the participants' health changes. However, these outcomes should be relevant for the target population. In that way, RCTs represent the type of primary study design that provides the most reliable evidence to implement therapies into the clinical practice. In this review, an outline of some aspects related to the choice of RCTs' outcomes was presented, focusing on the conduction of relevant trials in Paediatric Dentistry. The importance and necessity of defining a primary outcome were addressed, preferentially a clinically relevant endpoint. The patients should perceive this outcome, and changes in this variable should reflect directly patient's health improvement or impairment. Moreover, considerations about the objective or subjective variables, use of surrogate outcomes, and the increasing tendency to develop core outcome sets were also presented in this review. The main idea of this manuscript is the RCTs must evaluate outcomes relevant to the children's oral health in order to contribute to the implementation of treatments in the evidence-based health practice.
Assuntos
Odontopediatria , Ensaios Clínicos Controlados Aleatórios como Assunto , Criança , HumanosRESUMO
OBJECTIVES: To evaluate the impact of radiographic examination on changes of treatment decision related to dental caries compared to decisions guided by visual inspection alone in primary molars. MATERIALS AND METHODS: A total of 126 children aged 3-6 years who had sought dental assistance were randomly selected and examined by two calibrated examiners using visual inspection. A treatment plan regarding dental caries was generated based on this assessment. The same examiners then evaluated two bitewing radiographs, creating an additional treatment plan guided by concurrent assessment of both visual and radiographic methods. Occlusal and proximal surfaces of primary molars received a treatment decision as follows: (i) no treatment, (ii) non-operative treatment, and (iii) operative treatment. The frequency of changes in the treatment decision after radiographic examination was calculated, with subsequent Poisson multilevel regression analysis to evaluate variables influencing such changes. RESULTS: Changes from "no treatment" decided with visual inspection to "non-operative treatment" after radiographic evaluation occurred in 52 surfaces (3.2%), and changes to "operative treatment" were observed in 46 dental surfaces (2.8%). Furthermore, 50 surfaces (6.2%) had their treatment decision changed from non-operative to operative treatment after radiographic assessment. In addition, changes were significantly more frequent in children with higher caries experience, on proximal surfaces and in 1st primary molars. CONCLUSIONS: The impact of radiographic examination on changes in the treatment decision of primary molars made with visual inspection is modest. Changes are more frequent in children with higher caries experience and in proximal surfaces. CLINICAL RELEVANCE: The benefits of the radiographic method for detecting caries in children, as a protocol in the diagnostic process, seem to be overestimated; the impact of this method on changes in treatment decision made by visual examination alone is low. Radiographs could be, however, useful in particular conditions, such as in children with high caries experience.
Assuntos
Cárie Dentária , Radiografia Interproximal , Criança , Pré-Escolar , Estudos Controlados Antes e Depois , Cárie Dentária/diagnóstico por imagem , Cárie Dentária/terapia , Humanos , Dente Molar , Sensibilidade e Especificidade , Dente DecíduoRESUMO
We aimed to evaluate whether children's caries experience exerts an influence on the performance of visual and radiographic methods in detecting nonevident proximal caries lesions in primary molars. Eighty children (3-6 years old) were selected and classified as having a lower (≤3 decayed, missing, or filled surfaces; dmf-s) or higher (> 3 dmf-s) caries experience. Two calibrated examiners then assessed 526 proximal surfaces for caries lesions using visual and radiographic methods. As a reference standard, 2 other examiners checked the surfaces after temporary separation. Noncavitated and cavitated lesion thresholds were considered and Poisson multilevel regression analyses were conducted to evaluate the influence of caries experience on the performance of diagnostic strategies. Accuracy parameters stratified by caries experience were also derived. A statistically significant influence of caries experience was observed only for visual inspection, with more false-positive results in children with a higher caries experience at the noncavitated lesion threshold, and more false results at the cavitated threshold. The detection of noncavitated caries lesions in children with a higher caries experience was overestimated (specificity = 0.696), compared to children with a lower caries experience (specificity = 0.918), probably due to confirmation bias. However, the examiners underestimated the detection of cavitated lesions in children with a higher caries experience (sensitivity = 0.143) compared to lower-caries-experience children (sensitivity = 0.222), possibly because of representativeness bias. The radiographic method was not influenced by children's caries experience. In conclusion, children's caries experience influences the performance of visual inspection in detecting proximal caries lesions in primary teeth, evidencing the occurrence of cognitive biases.