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Effect of Periodontitis on the Quality and Quantity of Leukocyte- and Platelet-Rich Fibrin (L-PRF)

Effect of Periodontitis on the Quality and Quantity of Leukocyte- and Platelet-Rich Fibrin (L-PRF)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07693725
Enrollment
32
Registered
2026-07-09
Start date
2025-10-22
Completion date
2026-11-15
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

periodontitis, L-PRF, Growth Factors, Fibrin Matrix, Platelet Concentrates, Histology, Immunohistochemistry, ELISA

Brief 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 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.

Interventions

None listed

Sponsors

Suleyman Demirel University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Fibrin DensityBaselineHistological 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 ArchitectureBaselineHistological assessment of fibrin architecture in L-PRF membranes using Hematoxylin-Eosin and Martius Scarlet Blue staining.
Platelet Density in L-PRFBaselinePlatelet density within L-PRF membranes will be evaluated by immunohistochemical staining and reported according to staining intensity.
Neutrophil Density in L-PRFBaselineNeutrophil density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Monocyte/Macrophage Density in L-PRFBaselineMonocyte/macrophage density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
T-Lymphocyte Density in L-PRFBaselineT-lymphocyte density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
B-Lymphocyte Density in L-PRFBaselineB-lymphocyte density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Stem Cell Density in L-PRFBaselineStem cell density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
PDGF-AB Release1 hour, 24 hours and 7 daysPDGF-AB concentration released from L-PRF membranes will be quantified using enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL after incubation.
VEGF Release1 hour, 24 hours and 7 daysVEGF concentration released from L-PRF membranes will be quantified using enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL after incubation.
TGF-β1 Release1 hour, 24 hours and 7 daysTGF-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 Release1 hour, 24 hours and 7 daysIGF-1 concentration released from L-PRF membranes will be quantified using enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL after incubation.

Secondary

MeasureTime frameDescription
Probing Depth (PD)BaselineProbing depth will be measured at six sites per tooth using a Williams periodontal probe and recorded in millimeters (mm).
Clinical Attachment Level (CAL)BaselineClinical attachment level will be measured at six sites per tooth using a Williams periodontal probe and recorded in millimeters (mm).
Bleeding on Probing (BOP)BaselineBleeding on probing will be recorded at six sites per tooth and expressed as the percentage of bleeding sites (%).
Periodontal Inflamed Surface Area (PISA)BaselinePeriodontal 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).
White Blood Cell CountBaselinePeripheral white blood cell count will be measured using an automated hematology analyzer and reported as ×10³/µL.
Platelet CountBaselinePeripheral platelet count will be measured using an automated hematology analyzer and reported as ×10³/µL.
Mean Platelet Volume (MPV)BaselineMean platelet volume will be measured using an automated hematology analyzer and reported in femtoliters (fL).
Platelet Distribution Width (PDW)BaselinePlatelet distribution width will be measured using an automated hematology analyzer and reported as a percentage (%).
Mean Corpuscular Volume (MCV)BaselineMean corpuscular volume will be measured using an automated hematology analyzer and reported in femtoliters (fL).
Red Cell Distribution Width (RDW)BaselineRed cell distribution width will be measured using an automated hematology analyzer and reported as a percentage (%).

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORZuhal Yetkin Ay, Prof. Dr.

Suleyman Demirel University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026