A importância dos estudos clínicos randomizados e seu impacto na tomada de decisão clínica / The importance of randomized clinical trials and their impact on clinical decision making

Os ensaios clínicos randomizados (ECRs) são considerados o padrão ouro e o mais alto nível de evidência científica para estudos de intervenção, precedidos apenas pela síntese dos mesmos (revisões sistemáticas). Tanto os responsáveis pela tomada de decisões, quanto os desenvolvedores de diretrizes precisam usar tais estudos, bem como suas sínteses, para desenvolver diretrizes clínicas de alta qualidade para auxiliar os profissionais na tomada de decisões. Portanto, os ECRs precisam ser bem delineados para minimizar o risco de viés, a fim de construir evidências científicas confiáveis em relação aos benefícios e efeitos colaterais das intervenções clínicas, bem como para garantir a transparência na concepção da metodologia de estudo e na comunicação dos resultados. Ensaios clínicos mal delineados representam um risco para a prática clínica, assim como desperdício de tempo, esforço e recursos financeiros na ciência. Este comentário visa destacar e discutir questões relacionadas à qualidade dos ECRs e seu efeito na tomada de decisões clínicas, bem como enfatizar a conscientização sobre a necessidade de avaliar criteriosamente os ensaios clínicos que serão utilizados para embasar a prática clínica.

Randomized clinical trials (RCTs) are considered the gold standard and the highest level of scientific evidence, preceded only by systematic reviews with or without meta-analysis. Both policy makers and guideline developers need to use such studies, as well as systematic reviews of RCTs, to develop high-quality clinical guidelines to assist dentists in making clinical decisions. Therefore, randomized controlled trials need to be well designed and have a reduced number of systematic errors to build reliable scientific evidence regarding the benefits and side effects of clinical interventions, as well as to ensure transparency in the design of study methodology and reporting of results, all of which will reduce potential biases. Poorly designed clinical trials pose a risk to clinical practice, as well as a waste of time and effort for dentists and even a waste of resources in science. This commentary aims to highlight and discuss problems related to the quality of randomized controlled clinical trials and their effect on dental surgeons' clinical decision making, as well as emphasizing the importance of choosing high quality clinical trials as a basis for their clinical practice.

ART restorations for occluso-proximal cavities in primary molars: a two-year survival and cost analysis of an RCT comparing two GIC brands

Abstract There are many glass ionomer cements available on the Brazilian market for Atraumatic Restorative Treatment (ART), however, there is still a gap in the literature regarding their cost-effectiveness. Objectives To evaluate the influence of restorative materials (Ketac Molar, 3M ESPE; and Vitro Molar, Nova DFL) in the two-year survival rate and cost-effectiveness of occluso-proximal ART restorations in primary molars. Methodology A total of 117 children (aged four to eight years) with at least one occluso-proximal carious lesion in primary molars were selected and randomly divided in treatment groups (KM or VM) in this parallel randomized controlled trial. Treatments followed ART premises and were conducted in public schools by trained operators in Barueri, Brazil. A trained, calibrated, and blinded examiner performed the evaluations after two, six, 12, and 24 months (k=0.92). Kaplan-Meier survival analysis was used to estimate restoration survival and Cox regression was used to test the association with clinical factors (α=5%). For cost analysis, material and professional costs were considered. Monte Carlo analysis was used to generate a cost-effectiveness plane and bootstrapping was used to compare material costs over the years. Results The overall survival rate was 36.9% after two years (48.6% for KM and 25.4% for VM). Restorations with VM failed more than those with KM (HR=1.70; 95% CI=1.06-2.73; p=0.027). VM presented lower initial cost, but no difference was observed between groups considering the two-year incremental cost. Conclusion After a two-year evaluation, KM proved to be a better option than VM for occluso-proximal ART restorations in primary molars. ClinicalTrials.gov: NCT02267720