Proposal of a Clinical Endpoint for Periodontal Trials: The Treat-to-Target Approach.
Magda Feres, Belén Retamal‐Valdes, Marcelo Faveri, Poliana Mendes Duarte, Jamil Awad Shibli, Geisla Mary Silva Soares, Tamires Szeremeske Miranda, Flavia Teles, Max Goodson, Hatice Hastürk, Thomas E. Van Dyke, Benjamin Ehmke, Peter Eickholz, Ulrich Schlagenhauf, Joerg Meyle, Raphael Koch, Thomas Kocher, Thomas Hoffmann, Ti‐Sun Kim, Doğan Kaner, Luciene Cristina Figueiredo, Helio Doyle
Abstract
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.