[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612473":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":10,"responsibleParty":25,"collaborators":29,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":57,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":10},{"fullName":5,"class":6},"Ostergotland County Council, Sweden","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Periodontitis Group",null,"Adults diagnosed with periodontitis based on clinical criteria.",{"label":13,"type":10,"description":14,"interventionNames":10},"Healthy Control Group","Adults with no clinical signs of periodontal disease.",[16,21],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Shariel Sayardoust, DDS., PhD","CONTACT","+46736564648","shariel.sayardoust@regionostergotland.se",{"name":22,"role":18,"phone":23,"phoneExt":10,"email":24},"Magnus Falk, PhD","+460703857476","magnus.falk@mau.se",{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Shariel Sayardoust","Associate Professor",[30,32],{"name":31,"class":6},"Malmö University",{"name":33,"class":34},"Linkoeping University","OTHER_GOV","100612473","ai-assisted-saliva-diagnostics-using-an-electrochemical-sensor-platform-for-periodontitis-detection-salience-100612473",false,"NCT07254039","AI-Assisted Saliva Diagnostics Using an Electrochemical Sensor Platform for Periodontitis Detection (SALIENCE)","Development and Validation of an AI-Assisted Electrochemical Sensor Platform for Saliva-Based Diagnostics in Periodontitis","SALIENCE","Inclusion Criteria:\n\nAdults ≥18 years.\n\nAble and willing to provide written informed consent.\n\nAbility to provide an unstimulated whole saliva sample per protocol (no food, drink, gum, toothbrushing, or smoking within 60 minutes prior to sampling).\n\nPeriodontitis group: Clinical diagnosis of periodontitis according to 2018 AAP\u002FEFP criteria (e.g., interdental CAL ≥3 mm at ≥2 non-adjacent teeth with radiographic bone loss; probing pocket depth ≥4 mm in ≥2 teeth).\n\nHealthy control group: No clinical signs of periodontal disease (no probing depths \\>3 mm, bleeding on probing \\\u003C10%, and no radiographic bone loss).\n\nExclusion Criteria:\n\nSystemic antibiotics or systemic anti-inflammatory\u002Fimmunosuppressive therapy within the past 3 months.\n\nPeriodontal therapy (scaling\u002Froot planing or surgery) within the past 6 months.\n\nCurrent acute oral infection or abscess.\n\nSystemic conditions known to markedly alter saliva composition\u002Fflow (e.g., Sjögren's syndrome, prior head-and-neck radiation, ongoing chemotherapy, uncontrolled diabetes).\n\nUse of strongly xerogenic medications not on a stable dose ≥4 weeks, or clinically significant hyposalivation preventing sampling.\n\nInability to comply with sampling procedures (e.g., cannot abstain from food\u002Fdrink\u002Ftobacco for 60 minutes prior to sampling).\n\nPregnancy or lactation.",true,"ALL","18 Years","80 Years",{"count":48,"type":49},200,"ESTIMATED","OBSERVATIONAL","This observational study aims to develop and validate a novel, AI-assisted electrochemical sensor platform for saliva-based diagnostics in periodontitis. Periodontitis is a chronic inflammatory disease affecting the gums and supporting tissues of the teeth. Despite its high global prevalence, early diagnosis remains challenging because the disease often progresses silently until irreversible damage has occurred.\n\nSaliva offers a promising, non-invasive diagnostic medium that reflects both oral and systemic health. However, its biological complexity and variability have limited its clinical use. This project addresses these challenges by combining advanced electrochemical sensing with artificial intelligence (AI) and synthetic data generation to improve diagnostic precision and reliability.\n\nThe study involves the collection of saliva samples from adult participants with diagnosed periodontitis and from healthy controls. The samples will be analyzed using a modular sensor platform equipped with multiple electrodes that detect electrochemical signals from a wide range of salivary biomarkers. The sensor data will then be processed using machine learning models trained on both real and synthetic data to classify disease states.\n\nThe main goals are to:\n\nEvaluate the performance of the electrochemical sensor array for saliva analysis.\n\nDevelop and validate AI-based algorithms for detecting and differentiating between healthy and diseased samples.\n\nGenerate feasibility data supporting future clinical implementation of saliva-based diagnostics for periodontitis.\n\nThis interdisciplinary project combines expertise in clinical dentistry, biomedical engineering, and computer science. It is conducted in collaboration between Linköping University and Malmö University, with patient sampling carried out at an affiliated dental clinic.\n\nThe study is expected to result in a working proof-of-concept device that enables real-time, non-invasive detection of periodontitis at the point of care. By enabling earlier diagnosis and more personalized treatment, this technology may transform periodontal care and serve as a foundation for future saliva-based diagnostics targeting other oral and systemic diseases.",[53,54,55,56],"Periodontal Diseases","Biomarkers (D23.050.301)","Diagnostic","Saliva",[58,59,60,61,62],"Saliva Diagnostics","Electrochemical Sensor","AI-Assisted Diagnostics","Biomarkers","Periodontal diseases","NOT_YET_RECRUITING","2025-11-19",{"date":66,"type":67},"2025-11-28","ACTUAL",{"date":69,"type":49},"2025-12-01",{"date":71,"type":49},"2028-06-30",{"name":5,"class":6}]