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.
English speaking
At least 18 years old
Must be a patient of the UAB Dental School
Able to read and understand informed consent document
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
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.
Cohort
Prospective
E-PRF/rhBMP-2 (similar ratios)
Biological/VaccineDuring 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.
E-PRF/ACS/rhBMP-2
Biological/VaccinerhBMP-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/E-PRF
Biological/VaccinerhBMP-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 only
Biological/VaccineE-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.
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.
To more assess the capability of E-PRF without added rhBMP-2 to release any intrinsic autologous BMP-2 under experimental conditions.
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.
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