[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598871":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":61,"studyPopulation":61,"armGroups":70,"interventions":97,"overallOfficials":117,"centralContacts":122,"locations":128,"responsibleParty":146,"collaborators":61,"id":150,"slug":61,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":61,"eligibilityCriteria":154,"healthyVolunteers":151,"sex":155,"minAge":61,"maxAge":61,"enrollmentInfo":156,"targetDuration":61,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":131,"whyStopped":61,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"National and Kapodistrian University of Athens","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":61},[9],{"measure":10,"description":11,"timeFrame":12},"Change in serum high-sensitivity C-reactive protein (hs-CRP) levels","For hs-CRP, blood would be collected:\n\n* Before each periodontal session\n* 24 hours after each periodontal session\n* 7 days after each periodontal session","Baseline-7 days after the last periodontal session",[14,17,21,25,28,31,34,37,40,43,46,49,52,55,58],{"measure":15,"description":16,"timeFrame":12},"Changes in serum Interleukin 6 (IL-6)","For IL-6, blood would be collected:\n\n* Before each periodontal session\n* 24 hours after each periodontal session\n* 7 days after each periodontal session",{"measure":18,"description":19,"timeFrame":20},"Presence and load of bacteremia","culture, PCR, 16S rRNA sequencing","Baseline-15 minutes after the last periodontal session",{"measure":22,"description":23,"timeFrame":24},"Changes in mean Clinical Attachment Level (CAL)","CAL would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session.\n\nAll clinical measurements would be taken using a manual probe. CAL would be recorded at six sites per tooth. Third molars would be excluded from the measurements.","Baseline-8 weeks after the last periodontal session",{"measure":26,"description":27,"timeFrame":12},"Salivary CRP correlation with serum CRP","saliva CRP levels will be assessed and compared to serum",{"measure":29,"description":30,"timeFrame":12},"Changes in serum Tumor Necrosis Factor a (TNF-a) levels","For changes in TNF-a levels, blood would be collected:\n\n* Before each periodontal session\n* 24 hours after each periodontal session\n* 7 days after each periodontal session",{"measure":32,"description":33,"timeFrame":12},"Changes in Serum amyloid A (SAA) levels","For changes in SAA levels, blood would be collected:\n\n* Before each periodontal session\n* 24 hours after each periodontal session\n* 7 days after each periodontal session",{"measure":35,"description":36,"timeFrame":12},"Changes in Serum cystatin c levels","For changes in serum cystatin c levels, blood would be collected:\n\n* Before each periodontal session\n* 24 hours after each periodontal session\n* 7 days after each periodontal session",{"measure":38,"description":39,"timeFrame":12},"Changes in Matrix metalloproteinase-8 (MMP-8) levels","For changes in MMP-8 levels, blood would be collected:\n\n* Before each periodontal session\n* 24 hours after each periodontal session\n* 7 days after each periodontal session",{"measure":41,"description":42,"timeFrame":12},"Changes in serum D-dimers levels","For changes in serum D-dimers levels, blood would be collected:\n\n* Before each periodontal session\n* 24 hours after each periodontal session\n* 7 days after each periodontal session",{"measure":44,"description":45,"timeFrame":12},"Changes in serum Lipopolysaccharide (LPS) levels","For changes in serum LPS levels, blood would be collected:\n\n* Before each periodontal session\n* 24 hours after each periodontal session\n* 7 days after each periodontal session",{"measure":47,"description":48,"timeFrame":24},"Changes in mean Pocket Depth (PD)","PD would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session.\n\nAll clinical measurements would be taken using a manual probe. PD would be recorded at six sites per tooth. Third molars would be excluded from the measurements.",{"measure":50,"description":51,"timeFrame":24},"Changes in mean Gingival Recession (GR)","GR would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session.\n\nAll clinical measurements would be taken using a manual probe. GR would be recorded at six sites per tooth. Third molars would be excluded from the measurements.",{"measure":53,"description":54,"timeFrame":24},"Changes in Full-Mouth Plaque Score (FMPS)","FMPS would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session.\n\nAll clinical measurements would be taken using a manual probe. FMPS would be recorded at six sites per tooth. Third molars would be excluded from the measurements.",{"measure":56,"description":57,"timeFrame":24},"Changes in Full-Mouth Bleeding Score (FMBS)","FMBS would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session. All clinical measurements would be taken using a manual probe. FMBS would be recorded at six sites per tooth. Third molars would be excluded from the measurements.",{"measure":59,"description":60,"timeFrame":24},"Changes in simplified gingival index (s-GI)","s-GI would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session. All clinical measurements would be taken using a manual probe. s-GI would be recorded at four sites per tooth. Third molars would be excluded from the measurements.",null,{"allocation":63,"interventionModel":64,"interventionModelDescription":61,"primaryPurpose":65,"observationalModel":61,"timePerspective":61,"maskingInfo":66},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":67,"maskingDescription":61,"whoMasked":68},"SINGLE",[69],"OUTCOMES_ASSESSOR",[71,77,82,87,92],{"label":72,"type":73,"description":74,"interventionNames":75},"Full-Mouth SRP","EXPERIMENTAL","oral hygiene instructions and full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks.",[76],"Procedure: Scaling and Root Planing",{"label":78,"type":73,"description":79,"interventionNames":80},"SRP + Antibiotics","oral hygiene instructions and full mouth scaling and root planing in 24 hours along with antibiotic prophylaxis. Clinical re-evaluation in 8 weeks.",[76,81],"Drug: antibiotic prophylaxis",{"label":83,"type":73,"description":84,"interventionNames":85},"SRP + Laser","oral hygiene instructions and 810nm diode laser at the base of the gingival sulcus\u002Fpocket following by full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks.",[76,86],"Device: 810nm Diode Laser",{"label":88,"type":73,"description":89,"interventionNames":90},"SRP + Air Polishing","oral hygiene instructions and air polishing following by full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks.",[76,91],"Procedure: Air Polishing",{"label":93,"type":94,"description":95,"interventionNames":96},"Quadrant SRP (Control)","ACTIVE_COMPARATOR","Oral hygiene instructions, scaling and root planing per quadrant with an interval of 7 days per session. Clinical re-evaluation in 8 weeks after last session.",[76],[98,103,108,113],{"type":99,"name":100,"description":101,"armGroupLabels":102,"otherNames":61},"PROCEDURE","Scaling and Root Planing","Mechanical debridement of tooth surfaces using hand and ultrasonic instruments",[72,93,88,78,83],{"type":104,"name":105,"description":106,"armGroupLabels":107,"otherNames":61},"DRUG","antibiotic prophylaxis","2g Amoxicillin given 1 hour prior to instrumentation",[78],{"type":109,"name":110,"description":111,"armGroupLabels":112,"otherNames":61},"DEVICE","810nm Diode Laser","Laser applied at base of gingival pockets prior to mechanical debridement.",[83],{"type":99,"name":114,"description":115,"armGroupLabels":116,"otherNames":61},"Air Polishing","air flow-based mechanical debridement with erythritol powder",[88],[118],{"name":119,"affiliation":120,"role":121},"Madianos Phoebus","Professor","STUDY_CHAIR",[123],{"name":124,"role":125,"phone":126,"phoneExt":61,"email":127},"Zampa Evangelia","CONTACT","00306987027896","elina_zampa@windowslive.com",[129],{"facility":130,"status":131,"city":132,"state":61,"zip":61,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":140,"contacts":141},"Department of Periodontology, Dental School of Athens","RECRUITING","Athens","Greece","GR",{"type":136,"coordinates":137},"Point",[138,139],23.72784,37.98376,{"lat":139,"lon":138},[142],{"name":143,"role":125,"phone":144,"phoneExt":61,"email":145},"Prof. Madianos P., DDS, PhD","00302107461181","pmadian@dent.uoa.gr",{"type":147,"investigatorFullName":148,"investigatorTitle":149,"investigatorAffiliation":5,"oldNameTitle":61,"oldOrganization":61},"PRINCIPAL_INVESTIGATOR","Evangelia Zampa","Principal investigator - DDS, MSc","100598871",false,"NCT07077122","Evaluation of the Systemic Burden of Non-surgical Periodontal Therapy: A Randomized Clinical Trial on Five Different Treatment Protocols","Inclusion Criteria:\n\n* Periodontitis stage III or IV\n* Non-smokers or light smokers (\\\u003C10 cigarettes\u002Fday)\n* No NSAIDs in regular basis or antibiotics 3 months before\n* No previous periodontal treatment 12 months before\n* No presence of other acute or chronic infections\n* No systemic disease or medication known to affect the serum level of inflammatory markers (cyclooxygenase inhibitors, platelet aggregation inhibitors, lipid lowering agents, â-adrenoreceptor antagonists, angiotensin converting enzyme inhibitors, antidiabetic agents, estrogen-based medications, medication for autoimmune disease, magnesium or vitamin E supplements)\n* No pregnancy or lactation\n* Written informed consent.","ALL",{"count":157,"type":158},75,"ESTIMATED","INTERVENTIONAL",[161],"NA","Periodontitis is a chronic inflammatory disease of the periodontal tissues leading to the destruction of the tooth supporting structures. Despite the fact that periodontal bacteria are etiological agents, host susceptibility related to the inflammatory response to plaque bacteria is the main determinant of the development of periodontitis. Non-surgical periodontal therapy (NSPT) represents the base of any therapeutic approach. Its main component is the removal of bacterial deposits, i.e. soft biofilm or mineralized calculus, from the tooth surface via mechanical debridement.\n\nIt is well established that patients suffering from periodontitis present with a low-grade systemic inflammatory state when compared to healthy subjects. Increased concentrations of inflammatory biomarkers in systemic circulation, such as, C-reactive protein (CRP) and interleukin (IL)-6, have already been reported. A significant amount of evidence derived from epidemiological as well as experimental studies has implicated periodontitis as a putative risk factor for a number of systemic diseases, such as, cardiovascular diseases, diabetes and respiratory diseases having systemic low-grade inflammation as their underlying pathogenic mechanism. Furthermore, several intervention studies provide evidence that periodontal treatment may improve systemic inflammatory markers and potentially reduce the risk for cardio-metabolic diseases.\n\nHowever, periodontal therapy may pose a transient, short-term health hazard immediately after instrumentation of the root surface presumably due to the spill of bacteria and their products in the systemic circulation and the subsequent acute inflammatory response. Positive bacteremia in NSPT ranges from 13% to 80.9% after mechanical debridement depending primarily on the periodontal status of the patient, but also on the study design and the microbiological methodology.\n\nFinally, an important aspect concerning NSPT is method and duration of delivery. NSPT may be carried out with either hand instruments, power driven instruments, such as, ultrasonic and sonic or a \"blended approach\" using both. Besides these instruments, the adjunctive use of lasers or\u002Fand air powder technology has been proposed. Regarding duration, treatment may be staged over several visits with a quadrant approach, or with a full-mouth debridement approach, also referred to as an intensive treatment approach, which delivers complete debridement within 24 hours.\n\nThe aim of this clinical trial is to assess the immediate systemic burden of five different treatment protocols for the NSPT on:\n\n1. bacteremia\n2. serum inflammatory responses. Additionally, saliva CRP levels will be assessed and compared to serum. Moreover, the effectiveness of the treatment protocols on clinical periodontal parameters will be assessed.",[164],"Periodontitis",[166,167,168,169],"periodontitis","inflammatory markers","non-surgical periodontal therapy","bacteremia","2025-08-27",{"date":172,"type":173},"2025-09-04","ACTUAL",{"date":175,"type":173},"2025-08-25",{"date":177,"type":158},"2027-12-15",{"name":5,"class":6},1]