[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621596":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":44,"collaborators":18,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":18,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Universita di Verona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Gel therapy after non surgical therapy","EXPERIMENTAL","The test group will receive gel therapy immediately after non surgical treatment. The gel in use is a composition of Hyaluronic acid, Poloxamer, 2-Phenoxyethanol, Octedine HCL,Water (Pocket-X Gel Geistlich AG, Wolhusen, Switzerland). It is a patented liquid-to-gel device. Pocket-X® Gel is composed of: Poloxamer 407 with thermo-gelling properties, Octenidine, antimicrobial preservative, Hyaluronic acid to support tissue healing.",[13],"Device: Gel therapy after non surgical therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Non surgical therapy","NO_INTERVENTION","In the control group non surgical therapy was performed using mechanical and manual instrumentations (curettes and ultrasonic devices)",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","The gel in use is a composition of Hyaluronic acid, Poloxamer, 2-Phenoxyethanol, Octedine HCL,Water (Pocket-X Gel Geistlich AG, Wolhusen, Switzerland). It is a patented liquid-to-gel device. Pocket-X® Gel is composed of: Poloxamer 407 with thermo-gelling properties, Octenidine, antimicrobial preservative, Hyaluronic acid to support tissue healing. It promotes gingival healing and prevents bacterial recolonization of periodontal pockets, forming a protective physical barrier, allows to postpone or avoid long, complex and painful surgeries, ensuring the success of periodontal treatment, delaying any surgical interventions.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Alessia Pardo","CONTACT","+39 3494628471","Alessia.pardo@univr.it",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":35,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":18},"Alessia Pardo 3494628471 Alessia.pardo@univr.it","RECRUITING","Verona","Italy","37134","IT",{"type":39,"coordinates":40},"Point",[41,42],10.9938,45.43854,{"lat":42,"lon":41},{"type":45,"investigatorFullName":26,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","PhD, Researcher","100621596","pocket-x-gel-non-surgical-periodontal-therapy-100621596",false,"NCT07372677","Pocket-X Gel Non-surgical Periodontal Therapy","Clinical and Microbiological Effects of a Thermal-Gel Device in Periodontal Treatment: Diabetic vs Non-Diabetic Patients","DEFECT_PERIO","Inclusion Criteria:\n\nPatients normally eligible for the visit and for the non-surgical type of treatment for periodontal defects:\n\n* patients with an age between 18 and 80;\n* patients with: (i) Asa status I (no functional impairment due to pathologies), (ii) patients with type 2 diabetes (T2DM) with: glycated hemoglobin level HbA1c between 6.5 and 8.0%, on dietary therapy and\u002For with hypoglycemic drugs in regular follow-up at the diabetes service;\n* patients with chronic periodontitis stage 3 or 4, according to the new classification of periodontal diseases \\[Tonetti et al.\\]), verified clinically and radiographically: patients will be selected with interdental clinical attachment level (CAL) at the site of greatest loss ≥3 mm to ≥2 non-adjacent teeth, probing depth (PPD) ≥5 mm, bleeding on probing (BoP) and horizontal and\u002For vertical radiographic bone loss.\n\nExclusion Criteria:\n\n* Patients not eligible for the non-surgical type of treatment for periodontal defects:\n\n  * patients with a positive history of diseases with functional impairment (ASA status 2,3,4) or severe handicaps that could limit the ability to attend appointments;\n  * patients with uncontrolled\u002Fpoorly controlled DM at the time of study selection (e.g. type 1 diabetes mellitus and secondary forms of diabetes); patients with uncontrolled and serious diabetic complications (cardiovascular, renal, hepatic and nervous);\n  * poor compliance with treatment, with poor oral hygiene and motivation;\n  * not signing informed consent by patients.",true,"ALL","18 Years","80 Years",{"count":60,"type":61},70,"ESTIMATED","INTERVENTIONAL",[64],"NA","Evaluate from a clinical and microbiological point of view the effect of an adjunctive therapy based on a thermal-gelling device Pocket-X® Gel (Hyaluronic acid, Poloxamer, 2-Phenoxyethanol, Octedine HCL, Water), in the non-surgical treatment of periodontal defects, in a population of patients with T2DM compared to non-diabetic patients.\n\nDetermine whether periodontal defect healing is clinically and microbiologically different between T2DM patients and non-diabetic patients; whether periodontal treatment and maintenance can lead to improvement of conditions and stability over time also for diabetic conditions.",[67],"Diabete Type 2",[69,70,71],"Non-surgical periodontal therapy","Pocket-X gel","periodontitis in diabetes type-2","2026-05-28",{"date":74,"type":75},"2026-05-29","ACTUAL",{"date":77,"type":75},"2026-02-02",{"date":79,"type":61},"2030-01",{"name":5,"class":6},1]