Ireland
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Starting soon Observational

Effects of Standard PRP and Extracellular Vesicle-Enriched PRP on Human Gingival Fibroblasts

NCT07855822 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-10-11
Last updated
2026-10-02

Condition(s) studied

Periodontal RegenerationWound HealingFibroblast

Study summary

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

Sex
ALL
Min age
20 Years
Max age
40 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Age 20 to 40 years * Systemically healthy * Non-smoker * Not using anticoagulant medication * Willing to participate and able to provide written informed consent Exclusion Criteria: * History of bleeding disorder or coagulation abnormality * Use of medications affecting platelet function (e.g., antiplatelet or anticoagulant agents) * Acute infection * Pregnancy or breastfeeding * Systemic disease (e.g., diabetes, autoimmune or hematological disease) * Age under 20 or over 40 years

Primary outcome measure(s)

  • Gingival Fibroblast Proliferation — 24, 48, and 72 hours after treatment
    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).
  • Gingival Fibroblast Wound Closure (Scratch Assay) — Baseline, 24 hours, and 48 hours after scratch
    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).

Trial sites (1)

FacilityCityRegionStatus
Inonu University Faculty of Dentistry Malatya Battalgazi
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07855822 on ClinicalTrials.gov ↗ ← All trials in Turkey