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NCT Number: NCT07693725

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Suleyman Demirel University, Faculty of Dentistry, Department of Periodontology

Isparta, 32000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. Fibrin Architecture

    Time frame: Baseline

    Histological assessment of fibrin architecture in L-PRF membranes using Hematoxylin-Eosin and Martius Scarlet Blue staining.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Secondary outcomes

  1. Probing Depth (PD)

    Time frame: Baseline

    Probing depth will be measured at six sites per tooth using a Williams periodontal probe and recorded in millimeters (mm).

  2. Clinical Attachment Level (CAL)

    Time frame: Baseline

    Clinical attachment level will be measured at six sites per tooth using a Williams periodontal probe and recorded in millimeters (mm).

  3. Bleeding on Probing (BOP)

    Time frame: Baseline

    Bleeding on probing will be recorded at six sites per tooth and expressed as the percentage of bleeding sites (%).

  4. Periodontal Inflamed Surface Area (PISA)

    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).

  5. White Blood Cell Count

    Time frame: Baseline

    Peripheral white blood cell count will be measured using an automated hematology analyzer and reported as ×10³/µL.

  6. Platelet Count

    Time frame: Baseline

    Peripheral platelet count will be measured using an automated hematology analyzer and reported as ×10³/µL.

  7. Mean Platelet Volume (MPV)

    Time frame: Baseline

    Mean platelet volume will be measured using an automated hematology analyzer and reported in femtoliters (fL).

  8. Platelet Distribution Width (PDW)

    Time frame: Baseline

    Platelet distribution width will be measured using an automated hematology analyzer and reported as a percentage (%).

  9. Mean Corpuscular Volume (MCV)

    Time frame: Baseline

    Mean corpuscular volume will be measured using an automated hematology analyzer and reported in femtoliters (fL).

  10. Red Cell Distribution Width (RDW)

    Time frame: Baseline

    Red cell distribution width will be measured using an automated hematology analyzer and reported as a percentage (%).

Sponsors and collaborators

Lead sponsor

Suleyman Demirel University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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