[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622635":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":25,"responsibleParty":32,"collaborators":25,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":25,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":58,"whyStopped":25,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":25},{"fullName":5,"class":6},"Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"insertion of porcine collagenic graft in the sinus","EXPERIMENTAL","porcine graft, which, due to its deantigenation process, results to be completely enbibed with its native collagen. This was demonstrated to allow a better regeneration due to its angiogenic and osteogenic potential",[13],"Procedure: transcrestal sinus lift",{"label":15,"type":16,"description":17,"interventionNames":18},"bovine collagen enriched graft","ACTIVE_COMPARATOR","the collagen-enriched bovine-derived bone substitute is composed predominantly of deproteinized bovine bone granules combined with a minor fraction of highly purified porcine collagen. The addition of collagen improves the handling properties and moldability of the graft, facilitating its clinical application.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","transcrestal sinus lift","Transcrestal sinus floor elevation (tSFE) is a surgical technique released through the use of guided surgery and specifically designed drills aimed to release the sinus mucosa. The use of micro elevators is aimed to detach the mucosa from the bone and free the space for the graft material. Graft material is inserted using specific pluggers.",[15,9],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"luigi Canullo, Prof","CONTACT","+39 347 6201976","luigicanullo@yahoo.com",{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Luigi Canullo","professor","100622635","collagenic-vs-collagen-enriched-graft-in-sinus-elevation-rct-100622635",false,"NCT07386184","Collagenic vs Collagen-enriched Graft in Sinus Elevation: RCT","Histological and Radiological Evaluation of Collagenic Porcine Graft vs Collagen-enriched Bovine-derived Graft in Transcrestal Sinus Elevation. A Randomized Prospective, Controlled Study.","C vs CE","Inclusion Criteria:\n\n* Patient requiring vertical elevation of the maxillary sinus floor.\n* Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus \\\u003C5 mm.\n* Males and females between 30-80 years old\n* Patients with healthy periodontal conditions (treated periodontitis, PI\\\u003C25%, BoP\\\u003C25%).\n* Patients willing to sign an informed consent and participate in a clinical study.\n* Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.\n* Teeth at the surgical site requiring extraction were removed at least 12 weeks prior to sinus floor elevation.\n\nExclusion Criteria:\n\n* Patients who smoke more than 5 cigarettes\u002Fday\n* Pregnancy (confirmed by verbal inquiry)\n* Chronic systemic pathologies (e.g. diabetes) and neoplasms of the oro-facial district.\n* Patients undergoing treatment with antiresorptive agents.\n* Patients receiving systemic corticosteroid therapy.\n* Any site with a history of implant failure.\n* Dental sites with acute infections.\n* Chronic inflammatory diseases of the oral cavity.\n* Autoimmune diseases.\n* Documented hypersensitivity to any of the medications intended for use during the treatment protocol.\n* Substance abusers.\n* Patients with known collagen hypersensitivity.\n* Patients with hypersensitivity to porcine-derived materials.\n* History of malignant tumors of the maxillary sinus.\n* History of head\u002Fneck radiation therapy.","ALL","30 Years","80 Years",{"count":48,"type":49},24,"ESTIMATED","INTERVENTIONAL",[52],"NA","The goal of this clinical trial is to histologically understand if collagenic or collagen enriched graft in sinus lift of healthy volunteers needing for implants in the posterior maxillae may work. The main question it aims to answer are:\n\nwhich material works better histologically and radiologically? Researchers will compare a collagenic graft to collagen enriched graft to see if the osteointegration of the material is the same.\n\nParticipants will undergo a sinus lift with one of the two materials and after six month will undergo a bone sample collection to allow the implant insertion.\n\ntwelve moths thereafter, a radiograph will be taken to measure the extension of the bone regeneration and implant behavior",[55],"Sinus Lift Augmentation",[57],"Randomized controlled prospective clinical trial","NOT_YET_RECRUITING","2026-03-09",{"date":61,"type":62},"2026-03-10","ACTUAL",{"date":64,"type":49},"2026-03-19",{"date":66,"type":49},"2027-12-01",{"name":5,"class":6}]