Effect of Periodontitis on the Quality and Quantity of Leukocyte- and Platelet-Rich Fibrin (L-PRF)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Fibrin Density
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Fibrin Density
时间窗: 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
时间窗: Baseline
Histological assessment of fibrin architecture in L-PRF membranes using Hematoxylin-Eosin and Martius Scarlet Blue staining.
Platelet Density in L-PRF
时间窗: Baseline
Platelet density within L-PRF membranes will be evaluated by immunohistochemical staining and reported according to staining intensity.
Neutrophil Density in L-PRF
时间窗: Baseline
Neutrophil density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
Monocyte/Macrophage Density in L-PRF
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline
Stem cell density within L-PRF membranes will be evaluated by immunohistochemistry and reported according to staining intensity.
PDGF-AB Release
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Platelet Count(Baseline)
- Mean Platelet Volume (MPV)(Baseline)
- Platelet Distribution Width (PDW)(Baseline)
- Mean Corpuscular Volume (MCV)(Baseline)
- Red Cell Distribution Width (RDW)(Baseline)
研究者
Meryem KOKSALAN
Prinsipal Investigator
Suleyman Demirel University