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Tipo:	Artigo de Periódico
Título:	Randomized clinical trials in periodontology: focus on outcomes selection
Autor(es):	Claúdio Mendes Pannuti Fernando de Oliveira Costa Nathalia Vilela Souza Belen Retamal-Valdes Amanda Almeida Costa Cristiano Susin Magda Feres
Resumo:	Randomized clinical trials (RCTs) are human studies carried out to compare different treatments or interventions, and their results are used to support clinical decision-making and improve patient care. Herein, the aim of this study was to review the selection process of study outcomes in periodontology. Primary outcomes should draw the main conclusions of the study, whereas secondary outcomes should only be used to help explain the main findings and generate future research hypothesis. Outcomes are classified as clinically relevant (CROs) or surrogate outcomes. CROs – the first option for primary outcome variables - should convey not only substantial health benefits, but also be deemed important by patients. In periodontology, tooth loss/retention and oral health–related quality of life (OHRQoL) are examples of CROs. While tooth loss has main limitations as a primary outcome, emerging evidence suggest that patient-reported outcome measures (PROMs) can accurately detect OHRQoL following periodontal therapy. When CROs cannot be assessed, validated surrogate outcomes can be used as proxies. Primary outcome variables should reflect a treatment endpoint at the patient level that can be easily used to inform decision-making in daily practice. These outcomes should allow the implementation of a treat-to-target concept in which the intervention can be clearly judged against a prespecified treatment target. Recently, the presence of at most 4 sites with periodontal probing depth ≥5 mm post-treatment was suggested as an effective endpoint for periodontal trials. In perspective, a combination of validated clinical parameters and PROMs will provide a more comprehensive assessment of periodontal treatments.
Assunto:	Treatment outcome Periodontics Randomized controlled trial
Idioma:	eng
País:	Brasil
Editor:	Universidade Federal de Minas Gerais
Sigla da Instituição:	UFMG
Departamento:	FAO - DEPARTAMENTO DE CLÍNICA
Tipo de Acesso:	Acesso Aberto
Identificador DOI:	https://doi.org/10.1590/1807-3107bor-2021.vol35.0100
URI:	http://hdl.handle.net/1843/69592
Data do documento:	24-Set-2021
metadata.dc.url.externa:	https://www.scielo.br/j/bor/a/Q8BYsndhvc5h5Gdnm99yKvC/?lang=en
metadata.dc.relation.ispartof:	Brazilian Oral Research
Aparece nas coleções:	Artigo de Periódico

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