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

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Study description shortened, about 4 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07855822
Lead Sponsor Inonu University
Conditions
(from sponsor)
Periodontal Regeneration, Wound Healing, Fibroblast
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov