[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04670965":3,"trial-entities:NCT04670965":103,"trial-summary:NCT04670965":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":49,"secondary_outcomes":54,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":75,"locations":78,"central_contacts":87,"overall_officials":97,"references":101,"see_also_links":102},"NCT04670965","IRB-300005939","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","NOT_YET_RECRUITING","2028-07","2026-04","2026-04-20","2026-09","University of Alabama at Birmingham","OTHER",false,"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.","Innovations in biomedicine and recombinant protein technology show promising advances for the regeneration of advanced alveolar defects. Recombinant growth factors and biologics encourage minimally invasive procedures with improved clinical outcomes\u002Fhealing times in complex oral surgery procedures. Recombinant human bone morphogenic protein-2 (rhBMP-2) is a morphogen that is a well-known regulator of bone formation1 and has been widely studied for bone reconstructive treatments.2-6 RhBMP-2 is currently commercially available and loaded on an absorbable collagen sponge (ACS). This recombinant growth factor has been approved by the US Food and Drug Administration as an alternative to autogenous bone grafting in sinus augmentation and localized alveolar ridge augmentation for defects associated with extraction sockets. It is also used off-label for vertical bone augmentation. However, there are limitations of the ACS as a carrier because it is compressible and does not ideally support soft tissues to maintain space for osteogenesis to occur. Furthermore, the release kinetics of rhBMP-2 in a standardized in vitro environment from its ACS carrier are unknown and it is further unknown how such release would compare to the use of other carriers. Subcutaneous implantation in rats and implantation at orthotropic sites in rats and rabbits has also revealed that rhBMP-2-loaded ACS has a release of rhBMP-2 over 21 days with a half-life of 2 days. The use of an alternative delivery system may retain and sequester rhBMPs at the target site and extend its growth factor release over time. This may be clinically relevant as prolonging tissue exposure to an osteoinductive growth factor like rhBMP-2 could extend the period of osteoblastic bone deposition and improve repair at regenerative sites. E-PRF as an autologous carrier for rhBMP-2 may be advantageous based on its resorption properties of up to 4-6 months, as well as its ability to support the healing process due to the slow and gradual release of several growth factors including, PDGF-AA, PDGF-BB, TGF- β1,VEGF, IGF, and EGF. This study aims to quantify the release of rhBMP-2 over a 120 day period with the use of a novel delivery system, E-PRF.",[19],"Bone Loss",[21,22,23,24],"Platelet concentrates","Platelet-rich fibrin","Growth factor","Bone morphogenic protein","OBSERVATIONAL",null,[],{"count":29,"type":30},20,"ESTIMATED",[32,37,41,45],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BIOLOGICAL","E-PRF\u002FrhBMP-2 (similar ratios)","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.",[34],{"type":33,"name":38,"description":39,"armGroupLabels":40},"E-PRF\u002FACS\u002FrhBMP-2","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.",[38],{"type":33,"name":42,"description":43,"armGroupLabels":44},"rhBMP-2\u002FE-PRF","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",[42],{"type":33,"name":46,"description":47,"armGroupLabels":48},"E-PRF only","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.",[46],[50],{"measure":51,"description":52,"timeFrame":53},"To quantify any difference between test groups in the release of rhBMP-2 after application to E-PRF and ACS, E-PRF, and ACS.","The quanitites of rhBMP-2 at all time points from all groups will be compared using statistical analysis by two-way ANOVA with Bonferroni test.","From baseline to 6 months",[55],{"measure":56,"description":52,"timeFrame":53},"To more assess the capability of E-PRF without added rhBMP-2 to release any intrinsic autologous BMP-2 under experimental conditions.","ALL","18 Years","99 Years",true,{"inclusion":62,"exclusion":68,"raw_text":74},[63,64,65,66,67],"English speaking","At least 18 years old","Must be a patient of the UAB Dental School","Able to read and understand informed consent document","Previously treatment planned for a periodontal procedure that will utilize PRF, i.e. requiring venipuncture, as a part of the routine clinical care.",[69,70,71,72,73],"Non-English speaking","Less than 18 years old","Smokers\u002Ftobacco users (\\>10 cigarettes\u002Fday)","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","Patient-reported serious adverse events reported with venipuncture, blood sample collection, and\u002For blood donation.","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.",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":13,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"Birmingham","Alabama","35294-0007","United States",{"lat":85,"lon":86},33.52066,-86.80249,[88,93],{"name":89,"role":90,"phone":91,"email":92},"Maria Geisinger, DDS,MS","CONTACT","934-4984","miagdds@uab.edu",{"name":94,"role":90,"phone":95,"email":96},"Sarah Startley, DMD","975-8711","ss1971@uab.edu",[98],{"name":99,"affiliation":13,"role":100},"Maria Geisinger, DDS, MS","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Osteopenia",[],{"nct_id":4,"found":60,"summary":108,"prompt_version":118},{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an observational study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.","completed","Observational Study on rhBMP-2 Release for Bone Loss","This study is looking at how a bone-building protein, rhBMP-2 (recombinant human bone morphogenic protein-2), is released over time when combined with different carriers. Researchers are comparing E-PRF (enhanced Platelet-rich fibrin), a human blood product, to the FDA-approved absorbable collagen sponge (ACS), a combination of both, and E-PRF alone. The goal is to see if there are differences in how much rhBMP-2 is released from each carrier in a lab setting. This research could help improve treatments for bone loss. You might be able to join if you are an English-speaking patient of the UAB Dental School, at least 18 years old, and already planned for a periodontal procedure involving PRF. The study aims to measure the release of rhBMP-2 over six months.","The primary endpoint will be measured from baseline to 6 months.",123,"You would need to be a patient at the UAB Dental School and have a planned periodontal procedure that uses PRF, which involves a blood draw (venipuncture).","Not stated in the trial record.",[],"v2"]