Suspended

Growth Factor Release in PRF vs GEM21S for Bone Regeneration

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Study Aim

This study observes the difference in growth factor release between Platelet-Rich Fibrin and GEM21S for bone regeneration in participants.

What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Bone Diseases+2

+ Bone Diseases, Metabolic

+ Metabolic Diseases

From 18 to 99 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: August 2021
See protocol details

Summary

Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 31, 2021

Actual date on which the first participant was enrolled.

This study focuses on understanding how two different sources of a growth factor called PDGF-BB can help in healing bones and wounds, specifically in dental and orthopedic surgeries. PDGF-BB is known for its ability to promote cell growth and attract cells necessary for healing. This study compares the effectiveness of two types of treatments: Platelet Rich Fibrin (PRF), which is derived from the patient's own blood, and GEM 21S, which contains a lab-made version of PDGF-BB. The goal is to determine if adding GEM 21S to a bone graft, combined with PRF, can enhance the healing process and improve the handling characteristics of bone grafts, also known as "sticky bone," used in complex oral surgeries. Participants in this observational study will have treatments applied in a controlled lab setting to measure how much PDGF-BB is released from both PRF and GEM 21S. This is done to see which method releases more of the growth factor, which is crucial for effective wound healing and bone regeneration. The results are analyzed using statistical methods to ensure accuracy. The study aims to provide insights into which treatment method might offer better clinical outcomes for patients undergoing dental surgeries, potentially leading to faster recovery and improved bone healing.

Official TitleGrowth Factor Availability and Release Kinetics in PRF Versus GEM21S With and Without Bone Substitutes: An In Vitro Analysis
NCT04964466
Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic Diseases

Criteria

Inclusion Criteria: * English speaking * At least 18 years old * Able to read and understand informed consent document * Systemically healthy, non-smoker, no medications Exclusion Criteria: * 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Alabama at Birmingham

Birmingham, United StatesOpen University of Alabama at Birmingham in Google Maps
SuspendedOne Study Center