[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658772":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":22,"overallOfficials":22,"centralContacts":31,"locations":37,"responsibleParty":50,"collaborators":22,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":22,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":22,"studyType":68,"phases":22,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":81,"whyStopped":22,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Inonu University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":22},[9,13],{"measure":10,"description":11,"timeFrame":12},"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).","24, 48, and 72 hours after treatment",{"measure":14,"description":15,"timeFrame":16},"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).","Baseline, 24 hours, and 48 hours after scratch",[18],{"measure":19,"description":20,"timeFrame":21},"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.","Day 3 and day 7 after treatment",null,{"allocation":22,"interventionModel":22,"interventionModelDescription":22,"primaryPurpose":22,"observationalModel":6,"timePerspective":24,"maskingInfo":22},"PROSPECTIVE","Study design: This is a laboratory-based study using blood donated by healthy volunteers, with a paired design. Blood from each of six healthy donors will be processed into both standard PRP and EV-enriched PRP, and each donor's PRP will be compared only with the same donor's EV-enriched PRP. Samples will not be pooled; each donor's samples will be analyzed separately. This design aims to minimize the influence of biological variability between donors on the comparison.\n\nBlood collection and product preparation: Two tubes of peripheral venous blood (18 mL in total) will be collected from each volunteer. Standard PRP will be prepared using a commercially available, CE Class IIb certified, single-spin closed-system PRP kit (T-Lab, Turkey; 1150 RCF, 4 minutes). EV-enriched PRP will be prepared using the T-LAB Exomine kit (Turkey), in which Advanced PRX tubes with micro-lyzer blade technology activate platelets and induce EV release through mechanical stress. Stocks of PRP and EV-enriched PRP will be diluted in serum-free DMEM\u002FF12 to final concentrations of 50%, 25%, 10%, 5%, 2.5%, and 1%.\n\nCell culture: Human gingival fibroblasts (HGF-1, ATCC) will be cultured in DMEM\u002FF12 supplemented with 10% fetal bovine serum, 1% penicillin\u002Fstreptomycin, and 1% amphotericin B at 37°C and 5% CO2. Cells at passages 4 to 8 will be used in all experiments.\n\nCell proliferation assay: HGF-1 cells will be seeded in 96-well plates (2 x 10\\^3 cells\u002Fwell) and, after overnight attachment, treated with a negative control (serum-free DMEM), a positive control (DMEM with 10% FBS), six PRP concentrations, and six EV-enriched PRP concentrations (14 groups in total, in technical triplicate). Absorbance will be measured spectrophotometrically at 570 nm at 24, 48, and 72 hours, and relative proliferation (%) will be calculated against the negative control.\n\nWound healing (scratch) assay: HGF-1 cells will be seeded in 24-well plates (8 x 10\\^4 cells\u002Fwell). At 80% confluence a scratch will be created and cells will be treated using the same group layout. Images will be captured with a phase-contrast microscope at baseline, 24 hours, and 48 hours, and the percentage of cell-free area will be calculated with ImageJ software.\n\nGene expression analysis: After the most effective concentrations for proliferation and migration are identified, HGF-1 cells (5 x 10\\^4 cells\u002Fwell, 24-well plates) will be treated with a control (DMEM with 10% FBS) or the optimal PRP and EV-enriched PRP concentrations. On days 3 and 7, expression of TGF-beta1, PDGF-A, PDGF-B, COL1A2, VEGF, and EGF will be analyzed by RT-qPCR, with beta-actin as the reference gene. Relative fold change will be calculated using the 2\\^-ddCt method.\n\nSample size: Sample size was based on the large effect sizes reported in the literature for the effects of platelet concentrates on gingival fibroblast function. With a paired t-test, alpha = 0.05, and an assumed effect size of d = 1.5, six donors provide 83% statistical power.\n\nStatistical analysis: Normality will be assessed with the Shapiro-Wilk test. Paired comparisons between PRP and EV-enriched PRP will use the paired t-test or the Wilcoxon signed-rank test, depending on distribution. The combined effects of concentration and time will be evaluated with repeated-measures ANOVA (or the Friedman test) and appropriate post-hoc corrections. p \\\u003C 0.05 will be considered statistically significant.\n\nHypothesis: EV-enriched PRP will show superior biological effects on gingival fibroblast proliferation and wound healing compared with conventional PRP.","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.",[28],{"label":29,"type":22,"description":30,"interventionNames":22},"Healthy Blood Donors","Six systemically healthy, non-smoking adult volunteers aged 20 to 40 years who are not using anticoagulant or antiplatelet medication. Each participant provides a single peripheral venous blood sample (two tubes, 18 mL in total); no treatment is administered to participants. From each donor's blood, both standard platelet-rich plasma (PRP) and extracellular vesicle-enriched PRP (EV-enriched PRP) are prepared and tested in vitro on human gingival fibroblasts (HGF-1), allowing a paired, within-donor comparison of the two products.",[32],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},"Kübra Aral, Assoc. Prof.","CONTACT","+90 533 057 88 01","kubra.aral@inonu.edu.tr",[38],{"facility":39,"status":22,"city":40,"state":41,"zip":42,"country":43,"countryCode":22,"cosmosGeoPoint":44,"geoPoint":49,"contacts":22},"Inonu University Faculty of Dentistry","Malatya","Battalgazi","44100","Turkey (Türkiye)",{"type":45,"coordinates":46},"Point",[47,48],38.31667,38.35018,{"lat":48,"lon":47},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Kubra Aral","Associate Professor, Department of Periodontology, Faculty of Dentistry","100658772","effects-of-standard-prp-and-extracellular-vesicle-enriched-prp-on-human-gingival-fibroblasts-100658772",false,"NCT07855822","Effects of Standard PRP and Extracellular Vesicle-Enriched PRP on Human Gingival Fibroblasts","Comparative Evaluation of Standard Platelet-Rich Plasma (PRP) and Platelet-Derived Extracellular Vesicle-Rich Platelet-Rich Plasma (EV-rich PRP) on Human Gingival Fibroblast Function: An In Vitro Study","Inclusion Criteria:\n\n* Age 20 to 40 years\n* Systemically healthy\n* Non-smoker\n* Not using anticoagulant medication\n* Willing to participate and able to provide written informed consent\n\nExclusion Criteria:\n\n* History of bleeding disorder or coagulation abnormality\n* Use of medications affecting platelet function (e.g., antiplatelet or anticoagulant agents)\n* Acute infection\n* Pregnancy or breastfeeding\n* Systemic disease (e.g., diabetes, autoimmune or hematological disease)\n* Age under 20 or over 40 years",true,"ALL","20 Years","40 Years",{"count":66,"type":67},6,"ESTIMATED","OBSERVATIONAL","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.\n\nThe main questions this study aims to answer are:\n\n* Does EV-enriched PRP increase gingival fibroblast proliferation more than standard PRP?\n* Does EV-enriched PRP accelerate gingival fibroblast migration (wound closure) more than standard PRP?\n* Do the two products differ in their effects on the expression of growth factor and collagen genes in gingival fibroblasts?\n\nSix 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.",[71,72,73],"Periodontal Regeneration","Wound Healing","Fibroblast",[75,76,77,78,79,80],"Extracellular Vesicles","EV-Enriched PRP","Platelet-Rich Plasma","Exosomes","Human Gingival Fibroblasts","Growth Factors","NOT_YET_RECRUITING","2026-10-04",{"date":84,"type":85},"2026-10-07","ACTUAL",{"date":87,"type":67},"2026-10-11",{"date":89,"type":67},"2026-11-18",{"name":5,"class":6},1]