[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524160":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":36,"responsibleParty":54,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University of Turin, Italy","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hyaluronic acid","EXPERIMENTAL","Minimally invasive surgical technique with a combined approach using hyaluronic acid gel and a bone xenograft.",[13],"Device: Hyaluronic acid",{"label":15,"type":16,"description":17,"interventionNames":18},"Enamel matrix derivatives","ACTIVE_COMPARATOR","Minimally invasive surgical technique with a combined approach using enamel matrix derivatives gel and a bone xenograft.",[19],"Device: Enamel matrix derivatives",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Minimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Application of cross-linked hyaluronic acid gel composed of a mixture of cross-linked (1.6%) and natural (0.2%) hyaluronic acid (hyaDent BG, Regedent, Germany) through a syringe over a bone xenograft (Smartgraft, Regedent, Germany). The mixture will be then compacted within the intrabony component of the defect.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Minimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Enamel matrix derivatives gel (Emdogain, Straumann, Switzerland) will be applied on the dry root surfaces and left in place for at least 1 minute avoiding blood contamination. Subsequently, a bone xenograft (Smartgraft, Regedent, Germany) will be compacted within the intrabony component of the defect.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Mario Aimetti, PA","CONTACT","011 6331546","0039","mario.aimetti@unito.it",[37],{"facility":38,"status":39,"city":40,"state":25,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"CIR Dental School","RECRUITING","Turin","10126","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],7.68682,45.07049,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":53,"phoneExt":25,"email":35},"Mario Aimetti, Prof.","+39116331541",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Mario Aimetti","Associate Professor","100524160","periodontal-regeneration-with-hyaluronic-acid-or-enamel-matrix-derivatives-100524160",false,"NCT06105112","Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives","Minimally Invasive Periodontal Regeneration With a Combination Approach Using Either Hyaluronic Acid or Enamel Matrix Derivatives: a 24-month Multicenter Randomized Controlled Clinical Trial","Inclusion criteria:\n\n* Diagnosis of stage III-IV periodontitis.\n* Completed steps I-II periodontal therapy.\n* FMPS \\\u003C15% at 3-month re-evaluation.\n* FMBS \\\u003C15% at 3-month re-evaluation.\n* At least one site with intrabony defects and residual PPD ≥ 6 mm at re-evaluation, with a radiographic intrabony component ≥ 3 mm, and limited to no extension of the defect on the lingual or palatal side as assessed by preoperative bone sounding.\n* Intrasurgically, the defect has to present a non-supporting anatomy (1-2 residual walls in its most coronal portion) and it needs to be accessible by flap elevation only on one side (either buccal or oral).\n* Signed informed consent.\n\nExclusion criteria:\n\n* Compromised general health which contraindicates the study procedures (ASA III-VI patients).\n* Systemic diseases\u002Fmedications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).\n* Current smokers (self-reported, ≥ 10 cigarettes a day), users of chewing tobacco, and drug\u002Falcohol abusers.\n* Pregnant or nursing women.\n* Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.",true,"ALL","18 Years",{"count":69,"type":70},60,"ESTIMATED","INTERVENTIONAL",[73],"NA","To date, the quest for ideal biological inductors for periodontal regeneration is still ongoing, especially when facing non-containing defect anatomies. The primary aim of this study is to evaluate the clinical and radiographic performance of a bone graft combined with either enamel matrix derivatives or hyaluronic acid for periodontal regeneration of non-containing intrabony defects in terms of clinical attachment gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill). Moreover, this study aims to compare early wound healing and patient-reported outcome measures.",[76],"Periodontitis","2023-10-23",{"date":79,"type":80},"2023-10-27","ACTUAL",{"date":82,"type":80},"2023-10-01",{"date":84,"type":70},"2026-10-01",{"name":5,"class":6},1]