Randomized clinical trials in periodontology: focus on outcomes selection

Abstract 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.

Individuals' quality of life in periodontal maintenance therapy - critical literature review

Abstract: oral health is an integral part of an individual's general health, interfering with all dimensions of life: functional, aesthetic, psychological, social, physical, nutritional, and even psychosocial. hence oral health is directly related to quality of life. periodontitis is one of the most prevalent oral diseases and one of the major causes of tooth loss, impacting negatively on self-reported individuals' quality of life. periodontal maintenance therapy aims to effectively minimize the recurrence of periodontal disease, as well as the incidence of tooth loss. in periodontal literature, studies associated with quality of life indicators, presented in the form of questionnaires aimed at measuring the impact of periodontitis and tooth loss on self-reported individual's quality of life, highlight the "oral impacts on daily performance" (OIDP) and "oral health impact profile" (OHIP). as such, this study presents a critical review of the literature and describes the impact of periodontal disease and tooth loss on the quality of life of patients undergoing periodontal maintenance therapy.