Evaluation of Gingival Crevicular Fluid Parathyroid Hormone-Related Protein (PTHrP), RANKL, and OPG Levels in Periodontal Health, Gingivitis, and Periodontitis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- GCF Level of PTHrP
研究概览
简要总结
This observational study aims to evaluate the levels of specific biological markers-Parathyroid Hormone-Related Protein (PTHrP), RANKL, and Osteoprotegerin (OPG)-in the gingival crevicular fluid of individuals with different gum health conditions. The study includes a total of 81 participants, divided equally into three groups: 27 with healthy gums, 27 with gingivitis, and 27 with periodontitis. During a routine dental visit, participants undergo a standard periodontal examination to measure clinical signs such as plaque levels, gum bleeding, and pocket depths. Additionally, small sterile paper strips are gently placed in the gum crevices for 30 seconds to collect fluid samples. These fluid samples are then analyzed in a laboratory to understand how these specific proteins relate to gum health and the severity of gum disease.
详细描述
Periodontitis is a chronic inflammatory disease characterized by the destruction of tooth-supporting tissues and alveolar bone loss, primarily driven by an imbalance in bone metabolism. The regulation of bone turnover relies heavily on the balance between RANKL, which promotes osteoclast activation, and OPG, its natural inhibitor. Furthermore, PTHrP acts as a critical autocrine and paracrine regulator in periodontal tissue health and alveolar bone repair. The primary rationale of this research is to investigate the dynamic role of PTHrP in periodontal pathogenesis during both the inflammatory and tissue-destruction phases, evaluating its potential as a biological marker. Following a comprehensive clinical periodontal examination by a single calibrated clinician, specific sampling sites are isolated with cotton rolls and gently air-dried. Supragingival plaque is carefully removed prior to sampling. Gingival crevicular fluid (GCF) is then collected from these designated interproximal sites using sterile filter paper strips, which are inserted into the sulcus until mild resistance is felt and left in place for 30 seconds. Samples contaminated with blood or saliva are immediately excluded. The exact volume of the collected fluid is quantified using an electronic volume meter (Periotron 8010). All valid strips are subsequently transferred to microcentrifuge tubes and preserved at -80°C until laboratory processing. The biochemical quantification of PTHrP, RANKL, and OPG levels is performed via commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kits in accordance with the manufacturer's protocols.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 18 years and older.
- •Presence of at least 20 natural teeth, excluding third molars.
- •For the Periodontally Healthy GrouP: PD ≤ 3 mm, BOP < 10%, and no interproximal CAL or RBL.
- •For the Gingivitis Group: PD ≤ 3 mm, BOP ≥ 30%, and no interproximal CAL or RBL.
- •For the Periodontitis Group: Diagnosed with Stage III periodontitis (interproximal CAL ≥ 5 mm, PD ≥ 6 mm, and RBL extending to the middle third of the root or more apically).
排除标准
- •Presence of systemic diseases that may affect periodontal tissues (e.g., cardiovascular diseases, atherosclerosis, immune system diseases, rheumatoid arthritis, obesity, cancer, and diabetes).
- •Use of antibiotics within the last 3 months.
- •Use of any medication that may affect periodontal tissues.
- •Presence of infectious diseases such as HIV, HBV, or tuberculosis.
- •Pregnancy or lactation.
- •History of periodontal treatment within the last 6 months.
研究组 & 干预措施
Periodontitis
27 individuals diagnosed with Stage III periodontitis, characterized by interproximal CAL ≥ 5 mm, PD ≥ 6 mm, and RBL extending to the middle third of the root or more apically.
干预措施: Routine periodontal clinical examination and GCF collection (Other)
Periodontally Healthy
27 individuals with probing depth (PD) ≤ 3 mm, bleeding on probing (BOP) < 10%, and no interproximal clinical attachment loss (CAL) or radiographic bone loss (RBL).
干预措施: Routine periodontal clinical examination and GCF collection (Other)
Gingivitis
27 individuals with PD ≤ 3 mm, BOP ≥ 30%, and no CAL or RBL.
干预措施: Routine periodontal clinical examination and GCF collection (Other)
结局指标
主要结局
GCF Level of PTHrP
时间窗: Baseline (Single time point during the clinical examination)
The concentration of PTHrP in GCF samples will be quantitatively measured using commercial ELISA kits.
GCF Level of RANKL
时间窗: Baseline (Single time point during the clinical examination)
The concentration of RANKL in GCF samples will be quantitatively measured using commercial ELISA kits.
GCF Level of Osteoprotegerin
时间窗: Baseline (Single time point during the clinical examination)
The concentration of OPG in GCF samples will be quantitatively measured using commercial ELISA kits.
次要结局
- Probing Depth (PD)(Baseline (Single time point during the clinical examination))
- Clinical Attachment Level (CAL)(Baseline (Single time point during the clinical examination))
- Gingival Index (GI)(Baseline (Single time point during the clinical examination))
- Plaque Index (PI)(Baseline (Single time point during the clinical examination))
研究者
Bilge MERACI YILDIRAN
Assistant Professor
Abant Izzet Baysal University
