Effects of Standard PRP and Extracellular Vesicle-Enriched PRP on Human Gingival Fibroblasts
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-40
SponsorInonu University
About this trial
The goal of this study is to compare the biological effects of two blood-derived products, standard platelet-rich plasma (PRP) and extracellular vesicle-enriched PRP (EV-enriched PRP), on human gingival (gum) fibroblasts, the cells responsible for gum tissue repair. PRP is a concentrate of platelets prepared from a person's own blood and is used in periodontal and soft tissue regeneration because it releases growth factors. Extracellular vesicles (EVs) are nanometer-sized particles released by platelets that carry proteins and genetic material and may play an important role in tissue healing. No study has yet directly compared standard PRP with an EV-enriched formulation on gingival fibroblasts.
The main questions this study aims to answer are:
* Does EV-enriched PRP increase gingival fibroblast proliferation more than standard PRP? * Does EV-enriched PRP accelerate gingival fibroblast migration (wound closure) more than standard PRP? * Do the two products differ in their effects on the expression of growth factor and collagen genes in gingival fibroblasts?
Six healthy, non-smoking adult volunteers aged 20 to 40 years will each give a single blood sample (two tubes, 18 mL in total) from an arm vein. No treatment will be given to the volunteers. Each volunteer's blood will be processed into both standard PRP and EV-enriched PRP, and both products will be tested in the laboratory on a commercially available human gingival fibroblast cell line.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 20 to 40 years
Systemically healthy
Non-smoker
Not using anticoagulant medication
Disqualifiers
History of bleeding disorder or coagulation abnormality
Use of medications affecting platelet function (e.g., antiplatelet or anticoagulant agents)
Acute infection
Pregnancy or breastfeeding
Trial population
Systemically healthy, non-smoking adult volunteers aged 20 to 40 years, recruited at Inonu University Faculty of Dentistry, Department of Periodontology (Malatya, Turkey). Individuals receiving treatment for any disease, pregnant or breastfeeding women, and individuals with limited capacity to give informed consent will not be included.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
6 Participants
are grouped into 1 trial groupGroup A: Healthy Blood Donors
Trial outcomes
Primary outcomes
1
Gingival Fibroblast Proliferation
Proliferation of human gingival fibroblasts (HGF-1) treated with standard PRP versus EV-enriched PRP at six concentrations (50%, 25%, 10%, 5%, 2.5%, 1%), measured spectrophotometrically at 570 nm and expressed as relative proliferation (%) compared with the negative control (serum-free DMEM). Each donor's PRP is compared with the same donor's EV-enriched PRP (paired comparison).
Time frame
24, 48, and 72 hours after treatment2
Gingival Fibroblast Wound Closure (Scratch Assay)
Migration of human gingival fibroblasts (HGF-1) in an in vitro scratch assay after treatment with standard PRP versus EV-enriched PRP at six concentrations, assessed by phase-contrast microscopy and expressed as the percentage of remaining cell-free area calculated with ImageJ software. Each donor's PRP is compared with the same donor's EV-enriched PRP (paired comparison).
Time frame
Baseline, 24 hours, and 48 hours after scratchSecondary outcomes
1
Growth Factor and Collagen Gene Expression in Gingival Fibroblasts
Relative mRNA expression of TGF-beta1, PDGF-A, PDGF-B, COL1A2, VEGF, and EGF in human gingival fibroblasts (HGF-1) treated with the optimal concentrations of standard PRP and EV-enriched PRP (selected from the proliferation and migration assays), compared with control (DMEM with 10% FBS). Expression will be measured by RT-qPCR with beta-actin as the reference gene and reported as relative fold change using the 2\^-ddCt method.
Time frame
Day 3 and day 7 after treatmentSponsors and contacts
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Source ClinicalTrials.gov
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