PeriodontitisNCT07693725
Effect of Periodontitis on the Quality and Quantity of Leukocyte- and Platelet-Rich Fibrin (L-PRF)
An observational study of Periodontitis, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis is a chronic inflammatory disease that destroys the supporting tissues of the teeth and may also increase systemic inflammatory burden. Leukocyte- and platelet-rich fibrin (L-PRF) is an autologous blood-derived biomaterial widely used in periodontal and oral regenerative procedures because it contains… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2025to 15 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consists of systemically healthy, non-smoking adults aged 30-50 years who are referred to the Department of Periodontology, Faculty of Dentistry, Süleyman Demirel University, from the Department of Oral and Maxillofacial Radiology. Participants will be classified as either periodontally healthy or diagnosed with Stage III-IV generalized periodontitis according to the 2017 World Workshop Classification.
Who may be able to join
- Diagnosed as periodontally healthy or Stage III-IV generalized periodontitis according to the 2017 World Workshop Classification.
- Adults aged 30-50 years.
- Systemically healthy individuals.
- Non-smokers.
- Referred from the Department of Oral and Maxillofacial Radiology to the Department of Periodontology due to periodontal disease.
- Willing and able to provide written informed consent and participate in the study.
Who cannot join
- Refusal or inability to provide informed consent or participate in the study.
- Presence of any systemic disease.
- Current smokers.
- Pregnancy or breastfeeding.
- Individuals with physical or psychological disabilities that may interfere with study participation.
- History of substance abuse.
Show all 11Show fewer
- Severe malocclusion.
- Current orthodontic treatment, use of orthodontic appliances, or removable prostheses.
- Presence of acute dental pain or infection (e.g., dental caries, abscess, or acute odontogenic infection).
- History or presence of malignant disease.
- Participation in another clinical study at the time of enrollment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University, Faculty of Dentistry, Department of Periodontology
Isparta, Isparta, 32000
About this study
Periodontitis is a chronic inflammatory disease that destroys the supporting tissues of the teeth and may also increase systemic inflammatory burden. Leukocyte- and platelet-rich fibrin (L-PRF) is an autologous blood-derived biomaterial widely used in periodontal and oral regenerative procedures because it contains platelets, leukocytes, growth factors, and a fibrin matrix that promotes wound healing and tissue regeneration.
The purpose of this study is to determine whether Stage III-IV generalized periodontitis affects the quality and quantity of L-PRF. L-PRF obtained from periodontally healthy individuals and patients with generalized Stage III-IV periodontitis will be compared by evaluating fibrin architecture, cellular composition, and the temporal release of growth factors. The findings are expected to improve understanding of whether systemic inflammatory changes associated with periodontitis influence the biological properties of L-PRF and its regenerative potential.
Read the detailed description
Leukocyte- and platelet-rich fibrin (L-PRF) is a second-generation autologous platelet concentrate that contains a dense fibrin matrix enriched with platelets, leukocytes, cytokines, and growth factors. Owing to its regenerative properties, L-PRF has become widely used in periodontal regeneration and oral surgery. Although periodontitis is associated with systemic inflammation and alterations in circulating immune cells and inflammatory mediators, its potential influence on the biological characteristics of L-PRF has not been adequately investigated.
The objective of this prospective case-control study is to evaluate the effect of Stage III-IV generalized periodontitis on the quality and quantity of L-PRF. Periodontally healthy individuals and patients diagnosed with Stage III-IV generalized periodontitis will be included. Venous blood samples will be collected to prepare L-PRF membranes. Complete blood count parameters will also be recorded.
L-PRF membranes will be analyzed using histological and immunohistochemical methods to evaluate fibrin architecture and the distribution of platelets, neutrophils, monocytes/macrophages, T lymphocytes, B lymphocytes, and stem cells within the fibrin matrix. In addition, the temporal release of PDGF-AB, VEGF, TGF-β1, and IGF-1 from L-PRF membranes will be quantified by enzyme-linked immunosorbent assay (ELISA) after 1 hour, 24 hours, 3 days, and 7 days of incubation.
The primary objective is to determine whether periodontitis-related systemic inflammation alters the structural and biological characteristics of L-PRF. The results of this study will provide novel information regarding the potential impact of periodontal inflammation on the regenerative capacity of L-PRF and may contribute to optimizing its clinical use in regenerative therapies.
- Conditions
- Periodontitis
- Keywords
- periodontitis, L-PRF, Growth Factors, Fibrin Matrix, Platelet Concentrates, Histology, Immunohistochemistry, ELISA
- Medical subject headings
- Periodontitis
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 |
|---|---|---|
| Periodontally Healthy | Periodontally healthy participants providing venous blood samples for L-PRF preparation and laboratory analyses. | |
| Stage III-IV Generalized Periodontitis | Patients diagnosed with Stage III-IV generalized periodontitis providing venous blood samples for L-PRF preparation and laboratory analyses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrin Density
Histological evaluation of fibrin density in leukocyte- and platelet-rich fibrin (L-PRF) membranes using Martius Scarlet Blue (MSB) staining. Fibrin density will be assessed microscopically according to staining intensity.
Measured: Baseline
Fibrin Architecture
Histological assessment of fibrin architecture in L-PRF membranes using Hematoxylin-Eosin and Martius Scarlet Blue staining.
Measured: Baseline
Platelet Density in L-PRF
Platelet density within L-PRF membranes will be evaluated by immunohistochemical staining and reported according to staining intensity.
Measured: Baseline
Neutrophil Density in L-PRF
Neutrophil density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Measured: Baseline
Monocyte/Macrophage Density in L-PRF
Monocyte/macrophage density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Measured: Baseline
T-Lymphocyte Density in L-PRF
T-lymphocyte density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Measured: Baseline
B-Lymphocyte Density in L-PRF
B-lymphocyte density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Measured: Baseline
Stem Cell Density in L-PRF
Stem cell density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Measured: Baseline
PDGF-AB Release
PDGF-AB concentration released from L-PRF membranes will be quantified using enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL after incubation.
Measured: 1 hour, 24 hours and 7 days
VEGF Release
VEGF concentration released from L-PRF membranes will be quantified using enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL after incubation.
Measured: 1 hour, 24 hours and 7 days
TGF-β1 Release
TGF-β1 concentration released from L-PRF membranes will be quantified using enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL after incubation.
Measured: 1 hour, 24 hours and 7 days
IGF-1 Release
IGF-1 concentration released from L-PRF membranes will be quantified using enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL after incubation.
Measured: 1 hour, 24 hours and 7 days
Secondary outcomes (10)
Probing Depth (PD)
Probing depth will be measured at six sites per tooth using a Williams periodontal probe and recorded in millimeters (mm).
Measured: Baseline
Clinical Attachment Level (CAL)
Clinical attachment level will be measured at six sites per tooth using a Williams periodontal probe and recorded in millimeters (mm).
Measured: Baseline
Bleeding on Probing (BOP)
Bleeding on probing will be recorded at six sites per tooth and expressed as the percentage of bleeding sites (%).
Measured: Baseline
Periodontal Inflamed Surface Area (PISA)
Periodontal inflamed surface area will be calculated using probing depth, clinical attachment level, gingival recession, and bleeding on probing measurements and reported in square millimeters (mm²).
Measured: Baseline
White Blood Cell Count
Peripheral white blood cell count will be measured using an automated hematology analyzer and reported as ×10³/µL.
Measured: Baseline
Platelet Count
Peripheral platelet count will be measured using an automated hematology analyzer and reported as ×10³/µL.
Measured: Baseline
Mean Platelet Volume (MPV)
Mean platelet volume will be measured using an automated hematology analyzer and reported in femtoliters (fL).
Measured: Baseline
Platelet Distribution Width (PDW)
Platelet distribution width will be measured using an automated hematology analyzer and reported as a percentage (%).
Measured: Baseline
Mean Corpuscular Volume (MCV)
Mean corpuscular volume will be measured using an automated hematology analyzer and reported in femtoliters (fL).
Measured: Baseline
Red Cell Distribution Width (RDW)
Red cell distribution width will be measured using an automated hematology analyzer and reported as a percentage (%).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start22 Oct 2025
- Primary completion21 May 2026
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem KOKSALAN, Suleyman Demirel University
- Investigators
- Zuhal Yetkin Ay, Prof. Dr., Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693725
- Sponsor's protocol ID
- 39
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Periodontitis on the Quality and Quantity of Leukocyte- and Platelet-Rich Fibrin (L-PRF)
- ClinicalTrials.gov ID
- NCT07693725
- Acronym / sponsor ID
- 39
- Conditions
- Periodontitis
- Keywords
- periodontitis, L-PRF, Growth Factors, Fibrin Matrix, Platelet Concentrates, Histology, Immunohistochemistry, ELISA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 9 Jul 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.
Periodontitis is a chronic inflammatory disease that destroys the supporting tissues of the teeth and may also increase systemic inflammatory burden. Leukocyte- and platelet-rich fibrin (L-PRF) is an autologous blood-derived biomaterial widely used in periodontal and oral regenerative procedures because it contains platelets, leukocytes, growth factors, and a fibrin matrix that promotes wound healing and tissue regeneration.
The purpose of this study is to determine whether Stage III-IV generalized periodontitis affects the quality and quantity of L-PRF. L-PRF obtained from periodontally healthy individuals and patients with generalized Stage III-IV periodontitis will be compared by evaluating fibrin architecture, cellular composition, and the temporal release of growth factors. The findings are expected to improve understanding of whether systemic inflammatory changes associated with periodontitis influence the biological properties of L-PRF and its regenerative potential.
Detailed description
Leukocyte- and platelet-rich fibrin (L-PRF) is a second-generation autologous platelet concentrate that contains a dense fibrin matrix enriched with platelets, leukocytes, cytokines, and growth factors. Owing to its regenerative properties, L-PRF has become widely used in periodontal regeneration and oral surgery. Although periodontitis is associated with systemic inflammation and alterations in circulating immune cells and inflammatory mediators, its potential influence on the biological characteristics of L-PRF has not been adequately investigated.
The objective of this prospective case-control study is to evaluate the effect of Stage III-IV generalized periodontitis on the quality and quantity of L-PRF. Periodontally healthy individuals and patients diagnosed with Stage III-IV generalized periodontitis will be included. Venous blood samples will be collected to prepare L-PRF membranes. Complete blood count parameters will also be recorded.
L-PRF membranes will be analyzed using histological and immunohistochemical methods to evaluate fibrin architecture and the distribution of platelets, neutrophils, monocytes/macrophages, T lymphocytes, B lymphocytes, and stem cells within the fibrin matrix. In addition, the temporal release of PDGF-AB, VEGF, TGF-β1, and IGF-1 from L-PRF membranes will be quantified by enzyme-linked immunosorbent assay (ELISA) after 1 hour, 24 hours, 3 days, and 7 days of incubation.
The primary objective is to determine whether periodontitis-related systemic inflammation alters the structural and biological characteristics of L-PRF. The results of this study will provide novel information regarding the potential impact of periodontal inflammation on the regenerative capacity of L-PRF and may contribute to optimizing its clinical use in regenerative therapies.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy | – | –Periodontally healthy participants providing venous blood samples for L-PRF preparation and laboratory analyses. |
| Stage III-IV Generalized Periodontitis | – | –Patients diagnosed with Stage III-IV generalized periodontitis providing venous blood samples for L-PRF preparation and laboratory analyses. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of systemically healthy, non-smoking adults aged 30-50 years who are referred to the Department of Periodontology, Faculty of Dentistry, Süleyman Demirel University, from the Department of Oral and Maxillofacial Radiology. Participants will be classified as either periodontally healthy or diagnosed with Stage III-IV generalized periodontitis according to the 2017 World Workshop Classification.
Key inclusion criteria (6 listed)
- Diagnosed as periodontally healthy or Stage III-IV generalized periodontitis according to the 2017 World Workshop Classification.
- Adults aged 30-50 years.
- Systemically healthy individuals.
- Non-smokers.
- Referred from the Department of Oral and Maxillofacial Radiology to the Department of Periodontology due to periodontal disease.
Key exclusion criteria (11 listed)
- Refusal or inability to provide informed consent or participate in the study.
- Presence of any systemic disease.
- Current smokers.
- Pregnancy or breastfeeding.
- Individuals with physical or psychological disabilities that may interfere with study participation.
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
Fibrin Density
Time frame: Baseline
Histological evaluation of fibrin density in leukocyte- and platelet-rich fibrin (L-PRF) membranes using Martius Scarlet Blue (MSB) staining. Fibrin density will be assessed microscopically according to staining intensity.
Fibrin Architecture
Time frame: Baseline
Histological assessment of fibrin architecture in L-PRF membranes using Hematoxylin-Eosin and Martius Scarlet Blue staining.
Platelet Density in L-PRF
Time frame: Baseline
Platelet density within L-PRF membranes will be evaluated by immunohistochemical staining and reported according to staining intensity.
Neutrophil Density in L-PRF
Time frame: Baseline
Neutrophil density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Monocyte/Macrophage Density in L-PRF
Time frame: Baseline
Monocyte/macrophage density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
T-Lymphocyte Density in L-PRF
Time frame: Baseline
T-lymphocyte density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
B-Lymphocyte Density in L-PRF
Time frame: Baseline
B-lymphocyte density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Stem Cell Density in L-PRF
Time frame: Baseline
Stem cell density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
PDGF-AB Release
Time frame: 1 hour, 24 hours and 7 days
PDGF-AB concentration released from L-PRF membranes will be quantified using enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL after incubation.
VEGF Release
Time frame: 1 hour, 24 hours and 7 days
VEGF concentration released from L-PRF membranes will be quantified using enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL after incubation.
TGF-β1 Release
Time frame: 1 hour, 24 hours and 7 days
TGF-β1 concentration released from L-PRF membranes will be quantified using enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL after incubation.
IGF-1 Release
Time frame: 1 hour, 24 hours and 7 days
IGF-1 concentration released from L-PRF membranes will be quantified using enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL after incubation.
10 secondary outcomes
Probing Depth (PD)
Time frame: Baseline
Clinical Attachment Level (CAL)
Time frame: Baseline
Bleeding on Probing (BOP)
Time frame: Baseline
Periodontal Inflamed Surface Area (PISA)
Time frame: Baseline
White Blood Cell Count
Time frame: Baseline
Platelet Count
Time frame: Baseline
Mean Platelet Volume (MPV)
Time frame: Baseline
Platelet Distribution Width (PDW)
Time frame: Baseline
Mean Corpuscular Volume (MCV)
Time frame: Baseline
Red Cell Distribution Width (RDW)
Time frame: Baseline
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 9 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Zuhal Yetkin Ay, Prof. Dr. principal investigator
Suleyman Demirel University
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 Periodontitis, run by Suleyman Demirel 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 6 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrin Density (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.