[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473218":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":62,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":25,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Nova Southeastern University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft","EXPERIMENTAL","recombinant human platelet derived growth factor is a protein that is found in blood serum. It helps to recruit stem cells into the area to aid in cell differentiation and proliferation. When added to mineralized bone allograft, it stimulates the angiogenesis in the area, and this in turn may increase the outcomes of regeneration.",[13],"Biological: growth factors to help in regeneration",{"label":15,"type":16,"description":17,"interventionNames":18},"Enamel matrix derivatives (EMD) in combination with bone allograft.","ACTIVE_COMPARATOR","Enamel matrix derivatives are natural proteins that are produced in the developing dental follicle. It has been available for decades and has been proved to help in regeneration of intrabony defects when applied into the root surface. When combined with bone allograft, it results in regeneration of intrabony defects.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","growth factors to help in regeneration","regenerative therapy",[15,9],null,[27],{"name":28,"affiliation":5,"role":29},"Theofilos Koutouzis, DDS, MS","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Neshatafarin Manouchehri, D.D.S","CONTACT","7342494806","nm1859@mynsu.nova.edu",{"name":28,"role":33,"phone":37,"phoneExt":25,"email":38},"954-262-1742","tkoutouzis@nova.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Davie","Florida","33314","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-80.2331,26.06287,{"lat":51,"lon":50},[54,58],{"name":55,"role":33,"phone":56,"phoneExt":25,"email":57},"Arsalan Danesh, DDS","561-212-6377","ad2900@mynsu.nova.edu",{"name":59,"role":33,"phone":60,"phoneExt":25,"email":61},"Cristina Garcia Godoy, DDS","954-262-7388","cgarciag@nova.edu",{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100473218","phase-1-rh-pdgf-vs-emd-for-treatment-of-intra-bony-defects-100473218",false,"NCT05442034","Rh-PDGF vs EMD for Treatment of Intra-bony Defects","Rh-PDGF Versus Emdogain for Treatment of Intra-bony Defects","Inclusion Criteria:\n\n* Age is 18 years old and older\n* Absence of relevant medical conditions\n* Availability for 6-month follow-up\n* Subjects who recently have received scaling and root planing due to periodontal disease\n* Single-rooted and multi-rooted teeth in either the maxilla or the mandible.\n* Presence of interdental periodontal pocket with PD ≥ 6 mm associated to an intra-bony component ranged from 3 to 6 mm.\n* Non-contained intra-bony defects (1-wall, 2-wall intra-bony defects)\n* Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \\\u003C20% at surgery\n\nExclusion Criteria:\n\n* Female patients who are pregnant or planning to be pregnant during the period of the study\n* Heavy smokers (\\>10 cigarettes a day)\n* Subjects not willing to comply to the study protocol\n* Patients with uncontrolled diabetes (HbA1c \\>7.5)\n* Patients receiving medications that may affect periodontal status in the previous 6 months (e.g., Phenytoin, Alendronate)\n* Periapical lesion in the tested sites",true,"ALL","18 Years",{"count":75,"type":76},36,"ESTIMATED","INTERVENTIONAL",[79,80],"PHASE1","PHASE2","Treatment of intra-bony defects is challenging and requires extensive knowledge of the etiology, anatomy, occlusion, and available biomaterials that can be used to treat this kind of defects. Patients who received scaling and root planing at the college of dental medicine due to periodontal disease, will be screened for inclusion. Only subjects who showed persistent deep probing depth associated with an intrabony defect will be included and will be randomly allocated to one of two treatment groups. One group will be treated using recombinant human platelet derived growth factor (GEM-21) (test) added to allogenic bone graft, second group will be treated using enamel matrix derivatives (EMD) (control) with allograft. Both groups will be treated using the same surgical protocol. Patients will be followed up for a period of 6 months and 12 months, before getting re-evaluated for assessing the effectiveness of the applied therapies.",[83],"Intrabony Periodontal Defect",[85,86,87],"Periodontal regeneration","Inta-bony defects","Enamel matrix derivatives","2026-04-13",{"date":90,"type":91},"2026-04-16","ACTUAL",{"date":93,"type":91},"2023-01-01",{"date":95,"type":76},"2027-06-30",{"name":5,"class":6},1]