Periodontal RegenerationNCT07855822
Effects of Standard PRP and Extracellular Vesicle-Enriched PRP on Human Gingival Fibroblasts
An observational study of Periodontal Regeneration and Wound Healing, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Regeneration, Wound Healing, Fibroblast
- How many people
- 6 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Oct 2026to 18 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study 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.
Who may be able to join
- Age 20 to 40 years
- Systemically healthy
- Non-smoker
- Not using anticoagulant medication
- Willing to participate and able to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Inonu University Faculty of Dentistry
Malatya, Battalgazi, 44100
About this study
Official title: 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
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:
Read more
- 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.
Read the detailed description
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.
Blood 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/F12 to final concentrations of 50%, 25%, 10%, 5%, 2.5%, and 1%.
Cell culture: Human gingival fibroblasts (HGF-1, ATCC) will be cultured in DMEM/F12 supplemented with 10% fetal bovine serum, 1% penicillin/streptomycin, and 1% amphotericin B at 37°C and 5% CO2. Cells at passages 4 to 8 will be used in all experiments.
Cell proliferation assay: HGF-1 cells will be seeded in 96-well plates (2 x 10^3 cells/well) 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.
Wound healing (scratch) assay: HGF-1 cells will be seeded in 24-well plates (8 x 10^4 cells/well). 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.
Gene expression analysis: After the most effective concentrations for proliferation and migration are identified, HGF-1 cells (5 x 10^4 cells/well, 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.
Sample 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.
Statistical 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 < 0.05 will be considered statistically significant.
Hypothesis: EV-enriched PRP will show superior biological effects on gingival fibroblast proliferation and wound healing compared with conventional PRP.
- Conditions
- Periodontal Regeneration, Wound Healing, Fibroblast
- Keywords
- Extracellular Vesicles, EV-Enriched PRP, Platelet-Rich Plasma, Exosomes, Human Gingival Fibroblasts, Growth Factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24, 48, and 72 hours after treatment
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).
Measured: Baseline, 24 hours, and 48 hours after scratch
Secondary 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.
Measured: Day 3 and day 7 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start11 Oct 2026 (estimated)
- Primary completion18 Nov 2026 (estimated)
- Study completion18 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periodontal RegenerationStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Aral, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855822
- Sponsor's protocol ID
- IU-2026 PRP
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly because the study involves a small number of healthy donors and the data consist of in vitro laboratory measurements derived from donor blood products. Aggregated results will be reported in the resulting publication, and de-identified laboratory data may be made available by the corresponding author upon reasonable request.
Publications
Antich-Rossello M, Munar-Bestard M, Forteza-Genestra MA, Calvo J, Gaya A, Monjo M, Ramis JM. Evaluation of Platelet-Derived Extracellular Vesicles in Gingival Fibroblasts and Keratinocytes for Periodontal Applications. Int J Mol Sci. 2022 Jul 11;23(14):7668. doi: 10.3390/ijms23147668.
PubMed 35887008Nguyen PA, Pham TAV. Effects of platelet-rich plasma on human gingival fibroblast proliferation and migration in vitro. J Appl Oral Sci. 2018 Jul 10;26:e20180077. doi: 10.1590/1678-7757-2018-0077.
PubMed 29995149Kobayashi E, Fujioka-Kobayashi M, Sculean A, Chappuis V, Buser D, Schaller B, Dori F, Miron RJ. Effects of platelet rich plasma (PRP) on human gingival fibroblast, osteoblast and periodontal ligament cell behaviour. BMC Oral Health. 2017 Jun 2;17(1):91. doi: 10.1186/s12903-017-0381-6.
PubMed 28578703
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07855822
- Acronym / sponsor ID
- IU-2026 PRP
- Conditions
- Periodontal Regeneration, Wound Healing, Fibroblast
- Keywords
- Extracellular Vesicles, EV-Enriched PRP, Platelet-Rich Plasma, Exosomes, Human Gingival Fibroblasts, Growth Factors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 11 Oct 2026 (estimated)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 18 Nov 2026 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Blood 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/F12 to final concentrations of 50%, 25%, 10%, 5%, 2.5%, and 1%.
Cell culture: Human gingival fibroblasts (HGF-1, ATCC) will be cultured in DMEM/F12 supplemented with 10% fetal bovine serum, 1% penicillin/streptomycin, and 1% amphotericin B at 37°C and 5% CO2. Cells at passages 4 to 8 will be used in all experiments.
Cell proliferation assay: HGF-1 cells will be seeded in 96-well plates (2 x 10^3 cells/well) 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.
Wound healing (scratch) assay: HGF-1 cells will be seeded in 24-well plates (8 x 10^4 cells/well). 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.
Gene expression analysis: After the most effective concentrations for proliferation and migration are identified, HGF-1 cells (5 x 10^4 cells/well, 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.
Sample 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.
Statistical 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 < 0.05 will be considered statistically significant.
Hypothesis: EV-enriched PRP will show superior biological effects on gingival fibroblast proliferation and wound healing compared with conventional PRP.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study 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.
Key inclusion criteria (5 listed)
- Age 20 to 40 years
- Systemically healthy
- Non-smoker
- Not using anticoagulant medication
- Willing to participate and able to provide written informed consent
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gingival Fibroblast Proliferation
Time frame: 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)
Time frame: 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).
1 secondary outcome
Growth Factor and Collagen Gene Expression in Gingival Fibroblasts
Time frame: Day 3 and day 7 after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Results publication: PubMed 35887008Antich-Rossello M, Munar-Bestard M, Forteza-Genestra MA, Calvo J, Gaya A, Monjo M, Ramis JM. Evaluation of Platelet-Derived Extracellular Vesicles in Gingival Fibroblasts and Keratinocytes for Periodontal Applications. Int J Mol Sci. 2022 Jul 11;23(14):7668. doi: 10.3390/ijms23147668.
- Results publication: PubMed 29995149Nguyen PA, Pham TAV. Effects of platelet-rich plasma on human gingival fibroblast proliferation and migration in vitro. J Appl Oral Sci. 2018 Jul 10;26:e20180077. doi: 10.1590/1678-7757-2018-0077.
- Results publication: PubMed 28578703Kobayashi E, Fujioka-Kobayashi M, Sculean A, Chappuis V, Buser D, Schaller B, Dori F, Miron RJ. Effects of platelet rich plasma (PRP) on human gingival fibroblast, osteoblast and periodontal ligament cell behaviour. BMC Oral Health. 2017 Jun 2;17(1):91. doi: 10.1186/s12903-017-0381-6.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly because the study involves a small number of healthy donors and the data consist of in vitro laboratory measurements derived from donor blood products. Aggregated results will be reported in the resulting publication, and de-identified laboratory data may be made available by the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Regeneration and Wound Healing, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kübra Aral, Assoc. Prof. (+90 533 057 88 01, kubra.aral@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Fibroblast Proliferation (time frame: 24, 48, and 72 hours after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07855822, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.