protocolSection identificationModule nctId: NCT06261723, orgStudyIdInfo id: PI22/1009, briefTitle: Effect of Non-chirurgical Periodontal Treatment on the Immune System From a Gender Perspective, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Milagros Rocha Barajas, class: OTHER, collaborators name: Instituto de Salud Carlos III, descriptionModule briefSummary: The goal of this observational study is to evaluate non-surgical periodontal treatment in women and men with periodontitis with and without obesity. The main questions it aims to answer are:* If non-surgical periodontal treatment of patients with chronic periodontitis can modulate the innate and adaptive immune response taking into account patient gender and the coexistence of obesity* If there are specific miRNAs that can regulate this immune response and can be considered as suitable biomarkers and therapeutic targets.Obese or non-obese participants with periodontitis will receive non-surgical periodontal treatment, consisting of oral health guidance and mechanical periodontal debridement throughout the mouth using an ultrasonic device and manual curettes. Researchers will compare four groups: obese women, non-obese women, obese men, and non-obese men, to clarify the involment of immune response after treatment, considering the coexistence of obesity and potential gender differences., conditionsModule conditions: Periodontal Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: non-chirurgical periodontal treatment, outcomesModule primaryOutcomes measure: Changes in inflammasome complex activation grade in patients with chronic periodontitis with and without obesity, before and after non-surgical periodontal treatment., primaryOutcomes measure: Changes in endothelial function in the study population., primaryOutcomes measure: Changes in endothelial function at molecular level in the study population., primaryOutcomes measure: Changes in the systemic inflammation status in the study population., primaryOutcomes measure: Changes in the expression of genes related to inflammatory pathways in PBMC in the study population., primaryOutcomes measure: Changes in the expression of genes related to oxidative stress levels in PBMC in the study population., primaryOutcomes measure: Changes in the expression of genes related to cellular respiration in PBMC in the study population., primaryOutcomes measure: Sequence miRNAs in biological fluids in patients with chronic periodontitis with and without obesity, before and after non-surgical periodontal treatment., primaryOutcomes measure: Evaluate the distribution and phenotype of different T lymphocyte and monocyte subpopulations in the study population., secondaryOutcomes measure: Changes in the protein expression of autophagy markers in PBMC in the study population., secondaryOutcomes measure: Evaluate autophagy flux in the study population., secondaryOutcomes measure: Evaluate autophagosome formation in the study population., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Dr Peset, status: RECRUITING, city: Valencia, zip: 46017, country: Spain, contacts name: Milagros Rocha Barajas, PhD, role: CONTACT, phone: 0034 963 189 132, email: milagros.rocha@fisabio.es, contacts name: Milagros Rocha Barajas, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, locations facility: University Hospital Dr. Peset, status: RECRUITING, city: Valencia, zip: 46017, country: Spain, contacts name: Milagros Rocha Barajas, role: CONTACT, phone: 963188875, email: milagros.rocha@fisabio.es, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False