[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100414005":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":40,"centralContacts":44,"locations":54,"responsibleParty":67,"collaborators":10,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":10,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":10,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":93,"whyStopped":10,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"E-PRF\u002FrhBMP-2 (similar ratios)",null,"Subjects will be used to procure the venous blood samples to make the enhanced platelet rich fibrin (E-PRF). Subjects have an established treatment plan that utilizes autologous PRF as an adjunctive biologic therapy during periodontal treatment.",[13],"Biological: E-PRF\u002FrhBMP-2 (similar ratios)",{"label":15,"type":10,"description":11,"interventionNames":16},"E-PRF\u002FACS\u002FrhBMP-2",[17],"Biological: E-PRF\u002FACS\u002FrhBMP-2",{"label":19,"type":10,"description":11,"interventionNames":20},"rhBMP-2\u002FE-PRF",[21],"Biological: rhBMP-2\u002FE-PRF",{"label":23,"type":10,"description":11,"interventionNames":24},"E-PRF only",[25],"Biological: E-PRF only",[27,31,34,37],{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":10},"BIOLOGICAL","During its preparation, 1.5 mg\u002Fml rhBMP-2 will be incorporated into standardized samples to assure similar E-PRF to rhBMP-2 ratios. To allow for consistency across all samples, standardized E-PRF volume will be established using formation templates. Following its preparation, the E-PRF\u002FrhBMP2 scaffold will undergo a standard in vitro assay to investigate growth factor release over time (ELISA quantification assay). Briefly, the e-PRF\u002FrhBMP2 scaffold will be placed in a shaking incubator at 37 degree Celsius and assessed for growth factor release of rhBMP-2 over time.",[9],{"type":28,"name":15,"description":32,"armGroupLabels":33,"otherNames":10},"rhBMP-2 diluted to account for the additional volume from the E-PRF in other samples will be loaded onto lyophilized absorbable collagen sponges as per the package insert. After the addition of the rhBMP-2, the ACS will be cut into 2mm x 2mm pieces and incorporated into the E-PRF membrane. Following its preparation, rhBMP-2 release from the E-PRF\u002FACS\u002FrhBMP2 scaffold will be quantified using the ELISA quantification assay as described above.",[15],{"type":28,"name":19,"description":35,"armGroupLabels":36,"otherNames":10},"rhBMP-2 diluted to account for the additional volume from the E-PRF in other samples will be loaded onto lyophilized absorbable collagen sponges as per the package insert. Rh-BMP2 release will be quantified using the ELISA quantification assay as described above",[19],{"type":28,"name":23,"description":38,"armGroupLabels":39,"otherNames":10},"E-PRF will be prepared and standardized, but no rhBMP-2 will be added to the material. After preparation, the E-PRF scaffold assayed via ELISA quantification assay as described above to determine the release (if any) of intrinsic BMP-2 from the platelet concentrate scaffold.",[23],[41],{"name":42,"affiliation":5,"role":43},"Maria Geisinger, DDS, MS","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":10,"email":49},"Maria Geisinger, DDS,MS","CONTACT","934-4984","miagdds@uab.edu",{"name":51,"role":47,"phone":52,"phoneExt":10,"email":53},"Sarah Startley, DMD","975-8711","ss1971@uab.edu",[55],{"facility":5,"status":10,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":10},"Birmingham","Alabama","35294-0007","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-86.80249,33.52066,{"lat":65,"lon":64},{"type":43,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Maria L. Geisinger, DDS, MS","Principal Investigator","100414005","release-kinetics-of-rhbmp-2-using-e-prf-as-an-autologous-carrier-an-in-vitro-analysis-100414005",false,"NCT04670965","Release Kinetics of rhBMP-2 Using E-PRF as an Autologous Carrier: An In Vitro Analysis","Release Kinetics of rhBMP-2 Using E-PRF as an Autologous Carrier: An in Vitro Analysis","Inclusion Criteria:\n\n* English speaking\n* At least 18 years old\n* Must be a patient of the UAB Dental School\n* Able to read and understand informed consent document\n* Previously treatment planned for a periodontal procedure that will utilize PRF, i.e. requiring venipuncture, as a part of the routine clinical care.\n\nExclusion Criteria:\n\n* Non-English speaking\n* Less than 18 years old\n* Smokers\u002Ftobacco users (\\>10 cigarettes\u002Fday)\n* Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing as assessed by Board Certified Periodontal faculty at UAB Department of Periodontology\n* Patient-reported serious adverse events reported with venipuncture, blood sample collection, and\u002For blood donation.",true,"ALL","18 Years","99 Years",{"count":82,"type":83},20,"ESTIMATED","OBSERVATIONAL","This study is seeking to evaluate the binding of a commercially-available, recombinant human osteoinductive growth factor, rhBMP-2, to a human blood derived product scaffold, enhanced Platelet-rich fibrin (E-PRF), and the release of such a growth factor over time in an in vitro (laboratory) environment. The investigators will compare these release kinetics to those of the FDA approved carrier for rhBMP-2, an absorbable collagen sponge (ACS), a combination of E-PRF and ACS, and E-PRF alone.",[87],"Bone Loss",[89,90,91,92],"Platelet concentrates","Platelet-rich fibrin","Growth factor","Bone morphogenic protein","NOT_YET_RECRUITING","2026-04-16",{"date":96,"type":97},"2026-04-20","ACTUAL",{"date":99,"type":83},"2026-09",{"date":101,"type":83},"2028-07",{"name":5,"class":6},1]