Release Kinetics of rhBMP-2 Using E-PRF as an Autologous Carrier: An In Vitro Analysis
2 other identifiers
observational
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
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participants targeted
Target at below P25 for all trials
Started Sep 2026
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
Study Completion
Last participant's last visit for all outcomes
July 1, 2028
April 20, 2026
April 1, 2026
1.2 years
December 10, 2020
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
To more assess the capability of E-PRF without added rhBMP-2 to release any intrinsic autologous BMP-2 under experimental conditions.
From baseline to 6 months
Study Arms (4)
E-PRF/rhBMP-2 (similar ratios)
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.
E-PRF/ACS/rhBMP-2
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.
rhBMP-2/E-PRF
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.
E-PRF only
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.
Interventions
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/ACS/rhBMP2 scaffold will be quantified using the ELISA quantification assay as described above.
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
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.
During its preparation, 1.5 mg/ml 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/rhBMP2 scaffold will undergo a standard in vitro assay to investigate growth factor release over time (ELISA quantification assay). Briefly, the e-PRF/rhBMP2 scaffold will be placed in a shaking incubator at 37 degree Celsius and assessed for growth factor release of rhBMP-2 over time.
Eligibility Criteria
Participants must be at least 18 years old with demonstrated ability to understand and consent to the proposed study procedures. Subjects treated in the UAB School of Dentistry Periodontal Clinic and scheduled for procedures using platelet rich fibrin (PRF) were performed.
You may qualify if:
- 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.
You may not qualify if:
- Non-English speaking
- Less than 18 years old
- Smokers/tobacco users (\>10 cigarettes/day)
- 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/or blood donation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0007, United States
Biospecimen
Whole blood will be harvested to form L-PRF membranes, which will be used in in vitro clinical assessments.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Geisinger, DDS, MS
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 10, 2020
First Posted
December 17, 2020
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
April 20, 2026
Record last verified: 2026-04