Release Kinetics in PRF Versus GEM21S With and Without Bone Substitutes: An In Vitro Analysis

NCT04964466 | Active Not Recruiting

• 2 other identifiers: IRB-300005971UAB-Perio
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study is seeking to evaluate that platelet-derived growth factor-BB (PDGF-BB) is a proven wound healing and osteogenic protein that plays a critical role in wound healing and previous research has demonstrated a non-linear response where higher dosages produced less effect. As Platelet Rich Fibrin (PRF) contains numerous platelets, it contains PDGF-BB, but at levels lower than in the commercially available product and with inter-individual variation, GEM21S. To achieve both ideal handling and achieve ideal levels of PDGF-BB, there is a rationale to add GEM 21S recombinant human platelet-derived growth factor-BB (rhPDGF) to a bone graft prior to making "sticky bone".

Conditions

Bone Loss

Keywords

Platelet concentrates; Platelet-rich fibrin; Growth factor; Bone morphogenic protein

Outcome Measures

Primary Outcomes (1)

• To quantify any difference in the release of PDGF-BB after application to rhPDGF-BB and PRF

  The quantities of PDGF-BB statistical analysis using a two-way analysis of variance for the proliferation assay with Bonferroni test.

  From baseline to 10 days

Study Arms (4)

Amount of PDGF-BB in PRF preparation vs. GEM21

The release kinetics of PDGF-BB will be assessed for one PRF preparation from each of the six individual participants and one GEM 21S sample. The quantification will be performed at 60 minutes, 8 hours, 1 day, 3 days, and 10 days. The samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At each desired time point assessment, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol.

Biological: Amount of PDGF-BB in PRF preparation vs. GEM21

PDGF-BB available in PRF + bone substitutes vs. rhPDGF-BB+ bone substitutes

Growth factor release assessments will be made to determine the PDGF-BB present in the six prepared samples of the following: 1) PRF + mineralized freeze-dried corticocancellous allograft, 2) PRF + xenograft, and 3) PRF + B-TCP. Assessments will also be made for one sample of each of the following: 1) rhPDGF-BB + freeze-dried bone allograft, 2) rhPDGF-BB + xenograft, and 3) rhPDGF-BB+ B-TCP preparation. This assessment will be made at 60 minutes following the incorporation of the bone graft materials. During this time period, the samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At 60 minutes after preparation, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol.

Biological: Amount of PDGF-BB available in PRF + bone substitutes vs. rhPDGF-BB+ bone substitutes following preparation

: Release kinetics of PDGF-BB in PRF + bone substitutes vs. rhPDGF-BB + bone substitutes

The release kinetics of PDGF-BB will be assessed for six preparations of each of following: 1) PRF+ mineralized freeze-dried corticocancellous allograft, 2) PRF + bone xenograft, and 3) PRF + B-TCP. The release kinetics of PDGF-BB will also be assessed for one preparations of each of following: 1) rhPDGF-BB + mineralized freeze-dried corticocancellous allograft, 2) rhPDGF-BB + bone xenograft, 3) rhPDGF-BB + TCP. The quantification will be performed at 60 minutes, 8 hours, 1 day, 3 days, and 10 days. The samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At each desired time point assessment, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol.

Biological: Release kinetics of PDGF-BB in PRF + bone substitutes vs. rhPDGF-BB + bone substitutes

Release kinetics of PDGF-BB in rhPDGF-BB + PRF + bone substitutes

The quantification will be performed at 60 minutes, 8 hours, 1 day, 3 days, and 10 days. The samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At each desired time point assessment, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol. The samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At each desired time point assessment, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol.

Biological: Release kinetics of PDGF-BB in rhPDGF-BB + PRF + bone substitutes

Interventions

Amount of PDGF-BB in PRF preparation vs. GEM21 BIOLOGICAL

The quantification will be performed at 60 minutes, 8 hours, 1 day, 3 days, and 10 days. The samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At each desired time point assessment, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol.

Amount of PDGF-BB in PRF preparation vs. GEM21

Amount of PDGF-BB available in PRF + bone substitutes vs. rhPDGF-BB+ bone substitutes following preparation BIOLOGICAL

Growth factor release assessments will be made to determine the PDGF-BB present in the six prepared samples of the following: 1) PRF + mineralized freeze-dried corticocancellous allograft, 2) PRF + xenograft, and 3) PRF + B-TCP. Assessments will also be made for one sample of each of the following: 1) rhPDGF-BB + freeze-dried bone allograft, 2) rhPDGF-BB + xenograft, and 3) rhPDGF-BB+ B-TCP preparation. This assessment will be made at 60 minutes following the incorporation of the bone graft materials. During this time period, the samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At 60 minutes after preparation, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol.

PDGF-BB available in PRF + bone substitutes vs. rhPDGF-BB+ bone substitutes

Release kinetics of PDGF-BB in PRF + bone substitutes vs. rhPDGF-BB + bone substitutes BIOLOGICAL

The release kinetics of PDGF-BB will be assessed for six preparations of each of following: 1) PRF+ mineralized freeze-dried corticocancellous allograft, 2) PRF + bone xenograft, and 3) PRF + B-TCP. The release kinetics of PDGF-BB will also be assessed for one preparations of each of following: 1) rhPDGF-BB + mineralized freeze-dried corticocancellous allograft, 2) rhPDGF-BB + bone xenograft, 3) rhPDGF-BB + TCP. The quantification will be performed at 60 minutes, 8 hours, 1 day, 3 days, and 10 days. The samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At each desired time point assessment, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol.

: Release kinetics of PDGF-BB in PRF + bone substitutes vs. rhPDGF-BB + bone substitutes

Release kinetics of PDGF-BB in rhPDGF-BB + PRF + bone substitutes BIOLOGICAL

The quantification will be performed at 60 minutes, 8 hours, 1 day, 3 days, and 10 days. The samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At each desired time point assessment, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol. The samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At each desired time point assessment, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol.

Release kinetics of PDGF-BB in rhPDGF-BB + PRF + bone substitutes

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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
• Able to read and understand informed consent document
• Systemically healthy, non-smoker, no medications

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 healing

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0007, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood will be harvested to form PRF matrices, which will be used in Vitro clinical assessments.

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Prolactin-Releasing Hormone; Bone Substitutes; Becaplermin

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Biocompatible Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Proto-Oncogene Proteins c-sis; Platelet-Derived Growth Factor; Intercellular Signaling Peptides and Proteins; DNA-Binding Proteins; Biological Factors

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: July 6, 2021
• First Posted: July 16, 2021
• Study Start: August 31, 2021
• Primary Completion: July 31, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

US (1)