Suleyman Demirel University, Faculty of Dentistry, Department of Periodontology
Isparta, 32000, Turkey (Türkiye)
NCT Number: NCT07693725
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.
This study is active but is not currently recruiting participants.
Notify Me30 year–50 year
All sexes
Observational
Isparta, 32000, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline
Histological assessment of fibrin architecture in L-PRF membranes using Hematoxylin-Eosin and Martius Scarlet Blue staining.
Time frame: Baseline
Platelet density within L-PRF membranes will be evaluated by immunohistochemical staining and reported according to staining intensity.
Time frame: Baseline
Neutrophil density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Time frame: Baseline
Monocyte/macrophage density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Time frame: Baseline
T-lymphocyte density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Time frame: Baseline
B-lymphocyte density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Time frame: Baseline
Stem cell density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
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.
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.
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.
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.
Time frame: Baseline
Probing depth will be measured at six sites per tooth using a Williams periodontal probe and recorded in millimeters (mm).
Time frame: Baseline
Clinical attachment level will be measured at six sites per tooth using a Williams periodontal probe and recorded in millimeters (mm).
Time frame: Baseline
Bleeding on probing will be recorded at six sites per tooth and expressed as the percentage of bleeding sites (%).
Time frame: Baseline
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).
Time frame: Baseline
Peripheral white blood cell count will be measured using an automated hematology analyzer and reported as ×10³/µL.
Time frame: Baseline
Peripheral platelet count will be measured using an automated hematology analyzer and reported as ×10³/µL.
Time frame: Baseline
Mean platelet volume will be measured using an automated hematology analyzer and reported in femtoliters (fL).
Time frame: Baseline
Platelet distribution width will be measured using an automated hematology analyzer and reported as a percentage (%).
Time frame: Baseline
Mean corpuscular volume will be measured using an automated hematology analyzer and reported in femtoliters (fL).
Time frame: Baseline
Red cell distribution width will be measured using an automated hematology analyzer and reported as a percentage (%).
Suleyman Demirel University
Other
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