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临床试验/NCT07793370
NCT07793370进行中(未招募)不适用

Evaluation of Gingival Crevicular Fluid Parathyroid Hormone-Related Protein (PTHrP), RANKL, and OPG Levels in Periodontal Health, Gingivitis, and Periodontitis.

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bilge MERACI YILDIRAN

Assistant Professor

Abant Izzet Baysal University

研究点 (1)

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