[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645290":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":26,"responsibleParty":46,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Bioteck S.p.A.","INDUSTRY",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"H42 treated group",null,"28 patients treated with ultrasonic treatment and manual curettes + H42®",{"label":13,"type":10,"description":14,"interventionNames":10},"Control group","28 patients only with ultrasonic treatment and manual curettes",[16,22],{"name":17,"role":18,"phone":19,"phoneExt":20,"email":21},"Marco Morroni, PhD","CONTACT","389 059 0480","+39","m.morroni@bioteck.com",{"name":23,"role":18,"phone":24,"phoneExt":20,"email":25},"Anna Di Bona, PhD","32779983709","a.dibona@bioteck.com",[27],{"facility":28,"status":29,"city":30,"state":10,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Faculty of Dentistry, University of Seville","RECRUITING","Seville","41009","Spain","ES",{"type":35,"coordinates":36},"Point",[37,38],-5.97317,37.38283,{"lat":38,"lon":37},[41],{"name":42,"role":18,"phone":43,"phoneExt":44,"email":45},"Guillermo Machuca-Portillo, MD","954481128","+34","gmachuca@us.es",{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[49],{"name":50,"class":51},"University of Seville","OTHER","100645290","non-surgical-treatment-of-peri-implant-pockets-with-h42-100645290",false,"NCT07680491","Non-surgical Treatment of Peri-implant Pockets With H42","H42","Inclusion Criteria:\n\n* Men or women with age ≥ 25 and ≤ 65 years.\n* Subjects affected by peri-implant pockets with probing depth (PD) in the range between 6 to 8 mm.\n* Each subject can have from 1 to 5 defects.\n* Subjects willing to provide signed informed consent to clinical investigation participation.\n\nExclusion Criteria:\n\n* Use of aspirin and antiplatelet agents a week before treatment.\n* Subjects smokers ≥ 10 cigarettes per day.\n* Subjects presenting current or previous bleeding disorders.\n* Subjects taking or having indications for anticoagulant therapy.\n* Concomitant treatments or procedures to improve gum health over the last six months before the clinical investigation enrolment, such as HA gel treatments, injection of fillers, and surgery.\n* Subjects suffering from infectious diseases, including herpes simplex infection, active hepatitis, or human immunodeficiency virus.\n* Subjects with dental aesthetic surgery in the preceding 12 months before the clinical investigation enrolment.","ALL","25 Years","65 Years",{"count":63,"type":64},56,"ESTIMATED","OBSERVATIONAL","This prospective, observational study evaluates the efficacy and safety of H42 non-surgical treatment for peri-implant pockets. The trial involves 56 patients, with 28 subjects receiving the H42 treatment and 28 acting as a control group to monitor soft tissue healing and bone level changes.\n\nClinical outcomes focus on Pocket Probing Depth (PPD) and Silness and Löe Plaque Index (PI) measured at baseline, 1 month, and 3 months. Gingival inflammation, pain intensity on a 0-10 NRS scale, and absence of infection are monitored at baseline, 7, 14, and 21 days, and at 1 and 3 months. Additionally, a five-point tissue assessment evaluates color, suppuration, granulation tissue, bleeding, and incision margins. Radiographic analysis at baseline and 3 months uses standardized periapical x-rays to measure bone level, intra-bony defect height, width, and angulation. Safety is assessed through the continuous registration of adverse events.",[68],"Peri-implantitis",[57],"2026-07-01",{"date":72,"type":73},"2026-07-02","ACTUAL",{"date":75,"type":73},"2025-12-03",{"date":77,"type":64},"2027-09-30",{"name":5,"class":6},1]