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Proposal of a Clinical Endpoint for Periodontal Trials: The Treat-to-Target Approach.
Feres, Magda; Retamal-Valdes, Belen; Faveri, Marcelo; Duarte, Poliana; Shibli, Jamil; Soares, Geisla Mary Silva; Miranda, Tamires; Teles, Flavia; Goodson, Max; Hasturk, Hatice; Van Dyke, Thomas; Ehmke, Benjamin; Eickholz, Peter; Schlagenhauf, Ulrich; Meyle, Joerg; Koch, Raphael; Kocher, Thomas; Hoffmann, Thomas; Kim, Ti-Sun; Kaner, Dogan; Figueiredo, Luciene Cristina; Doyle, Helio.
Afiliação
  • Feres M; Department of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil; Email mferes@ung.br.
  • Retamal-Valdes B; Department of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
  • Faveri M; Department of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
  • Duarte P; Department of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil; Department of Periodontology, School of Advanced Dental Sciences, College of Dentistry, University of Florida, Gainesville, Florida, The United States of America.
  • Shibli J; Department of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
  • Soares GMS; Department of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil; Department of Stomatology, Federal University of Parana, Parana, Brazil.
  • Miranda T; Department of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
  • Teles F; School of Dental Medicine,University of Pennsylvania, Philadelphia, Pennsylvania, The United States of America; The Forsyth Institute, Cambridge, MA, USA.
  • Goodson M; The Forsyth Institute, Cambridge, MA, USA.
  • Hasturk H; The Forsyth Institute, Cambridge, MA, USA.
  • Van Dyke T; The Forsyth Institute, Cambridge, MA, USA.
  • Ehmke B; Department of Periodontology, University Hospital Muenster, Muenster, Germany.
  • Eickholz P; Department of Periodontology, Johann Wolfgang Goethe-University, Frankfurt, Germany.
  • Schlagenhauf U; Department of Periodontology, University Hospital Wuerzburg, Wuerzburg, Germany.
  • Meyle J; Department of Periodontology, University of Giessen, Giessen, Germany.
  • Koch R; Institute of Biostatistics and Clinical Research, University of Munster, Munster, Germany.
  • Kocher T; Department of Restorative Dentistry, Periodontology, Endodontology, and Preventive and Pediatric Dentistry, University Medicine, Greifswald, Germany.
  • Hoffmann T; Dresden International University, Dresden, Germany.
  • Kim TS; Section of Periodontology, Dept. of Conservative Dentistry, University Hospital Heidelberg, Heidelberg, Germany.
  • Kaner D; Department of Periodontology, Dental School, Faculty of Health, University of Witten/Herdecke, Witten, Germany and Departments of Periodontology and Synoptic Dentistry, Charité Centrum 3, Charité University Medicine Berlin, Berlin, Germany.
  • Figueiredo LC; Department of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
  • Doyle H; Department of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
J Int Acad Periodontol ; 22(2): 41-53, 2020 04 01.
Article em En | MEDLINE | ID: mdl-32224549
OBJECTIVE: The selection of proper outcome measures is a critical step in clinical research. Most randomized clinical trials (RCTs) assessing the effects of initial anti-infective periodontal therapies use surrogate outcomes as primary outcome variables, such as mean changes in probing depth (PD) or in clinical attachment. However, these parameters do not reflect disease remission/control at patient level, which has led to subjective interpretations of the data from RCTs and Systematic Reviews. Based on a comprehensive analysis of 724 patients from USA, Germany and Brazil treated for periodontitis, this paper suggests that the clinical endpoint of "≤4 sites with PD≥5mm" is effective in determining disease remission/control after active periodontal treatment and therefore, may represent a pertinent endpoint for applying the treat-to-target concept in RCTs. Furthermore, regression models showed that the presence of >10% and >20% sites with bleeding on probing in the mouth post-treatment increases the risk of a patient leaving the endpoint from 1-2 years (OR=3.5 and 8.7, respectively). Researchers are encouraged to present results on this outcome when reporting their trials, as this will allow for an objective comparison across studies and facilitate systematic reviews, and consequently, the extrapolation of data from research to clinical practice.
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Base de dados: MEDLINE Assunto principal: Periodontite Tipo de estudo: Clinical_trials / Prognostic_studies / Systematic_reviews Limite: Humans País/Região como assunto: America do sul / Brasil / Europa Idioma: En Revista: J Int Acad Periodontol Assunto da revista: ODONTOLOGIA Ano de publicação: 2020 Tipo de documento: Article
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Base de dados: MEDLINE Assunto principal: Periodontite Tipo de estudo: Clinical_trials / Prognostic_studies / Systematic_reviews Limite: Humans País/Região como assunto: America do sul / Brasil / Europa Idioma: En Revista: J Int Acad Periodontol Assunto da revista: ODONTOLOGIA Ano de publicação: 2020 Tipo de documento: Article