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

NCT07693725 | Active Not Recruiting

• 1 other identifier: 39
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

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

Outcome Measures

Primary Outcomes (12)

• 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.

  Baseline

• Fibrin Architecture

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

  Baseline

• Platelet Density in L-PRF

  Platelet density within L-PRF membranes will be evaluated by immunohistochemical staining and reported according to staining intensity.

  Baseline

• Neutrophil Density in L-PRF

  Neutrophil density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  1 hour, 24 hours and 7 days

Secondary Outcomes (10)

• Probing Depth (PD)

  Baseline

• Clinical Attachment Level (CAL)

  Baseline

• Bleeding on Probing (BOP)

  Baseline

• Periodontal Inflamed Surface Area (PISA)

  Baseline

• White Blood Cell Count

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University, Faculty of Dentistry, Department of Periodontology

Isparta, Isparta, 32000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples will be collected for complete blood count analysis and preparation of leukocyte- and platelet-rich fibrin (L-PRF). L-PRF membranes will be retained for histological and immunohistochemical analyses. Culture supernatants obtained after incubation of L-PRF membranes at different time points (1 hour, 24 hours, 3 days, and 7 days) will be stored at -80°C until ELISA analysis of growth factors (PDGF-AB, VEGF, TGF-β1, and IGF-1). Histological paraffin blocks and tissue sections will also be retained for microscopic evaluation.

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Zuhal Yetkin Ay, Prof. Dr.

  Suleyman Demirel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinsipal Investigator

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 9, 2026
• Study Start: October 22, 2025
• Primary Completion: May 21, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)