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临床试验/NCT07025291
NCT07025291已完成不适用

Evaluation of Salivary Hypoxia-Inducible Factor -2 Alpha, Matrix Metalloproteinase-9 and Tartrate-Resistant Acid Phosphatase-5b Levels in Individuals With Different Periodontal Diseases

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Salivary HIF-2α levels

研究概览

简要总结

The aim of this study is to compare the salivary levels of HIF-2 alpha, MMP-9, and TRAP-5b among healthy individuals, patients with gingivitis, and patients with periodontitis; to examine the relationship between these levels and clinical parameters; and to determine their effectiveness in distinguishing periodontal disease from a healthy condition. It will be evaluated whether these biochemical mediators can be used as diagnostic biomarkers in the diagnosis of periodontal disease.

Periodontal health is defined as the absence of signs of inflammation. Gingivitis is an inflammation of the gums and, if left untreated, can progress to periodontitis, a more severe condition characterized by the destruction of the supporting structures of the teeth. In this destruction, the host immune response to bacterial products and various inflammatory mediators (cytokines, MMPs) play a role.

MMP-9 plays a significant role in the progression of inflammation and tissue damage. HIF-2 alpha is a factor that regulates bone formation and resorption and is activated in hypoxic or inflammatory environments. TRAP-5b is a specific marker of osteoclast activity and bone resorption. In the literature, there is no study that evaluates these three biomarkers together in saliva samples in the context of periodontal disease.

This study aims to investigate the changes in these salivary biomarkers in the presence of periodontal disease, their diagnostic potential, and their relationship with clinical parameters. The findings may also provide insights for future treatments targeting these cytokine pathways.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy (The identification of healthy volunteers will be based on patients' self-reported medical history; no additional diagnostic tests will be conducted.)
  • Having at least twenty permanent teeth in the mouth
  • Non-smoker
  • Not on any continuous medication
  • No use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids in the last 6 months
  • Not pregnant or lactating
  • No periodontal treatment within the last 6 months
  • Willing to participate in the study and having signed the "Informed Consent Form"
  • Between 18 and 65 years of age

排除标准

  • Having any oral or systemic disease
  • Being on regular systemic medication
  • Being pregnant or in the lactation period
  • Having received periodontal treatment within the last 6 months
  • Having used antibiotics, anti-inflammatory drugs, or systemic corticosteroids in the last 6 months
  • Being under 18 years of age

研究组 & 干预措施

healthy periodontium

Experimental

According to the evaluation made in 6 areas of each tooth, 20 individuals who showed bleeding on probing in less than 10% of the area, had a probing depth of less than 4 mm and had no attachment loss will be included in the study.

干预措施: saliva obtaining (Diagnostic Test)

periodontitis

Experimental

According to the evaluation made in 6 areas of each tooth, 20 individuals who showed bleeding on probing in 30% or more areas, who had a probing pocket depth of 5 mm or more and attachment loss of 4 mm or more in at least 2 non-adjacent teeth in each quadrant jaw, and who had coronal 1/3 or more (horizontal and/or vertical) bone loss on radiographs will be included in the study.

干预措施: saliva obtaining (Diagnostic Test)

Gingivitis

Experimental

According to the evaluation made in 6 areas of each tooth, 20 individuals who showed bleeding on probing in more than 10% of the area, had a probing depth of less than 4 mm and had no attachment loss will be included in the study.

干预措施: saliva obtaining (Diagnostic Test)

结局指标

主要结局

Salivary HIF-2α levels

时间窗: 24 hours after taking the clinical measurements at the first visit

the total amount of HIF-2α in saliva

Salivary TRAP-5b levels

时间窗: 24 hours after taking the clinical measurements at the first visit

the total amount of TRAP-5b in saliva

Salivary MMP-9 levels

时间窗: 24 hours after taking the clinical measurements at the first visit

the total amount of MMP-9 in saliva

次要结局

  • probing depth(During the first 1 day visit)
  • clinical attachment level(During the first 1 day visit)
  • plaque index(During the first 1 day visit)
  • gingival index(During the first 1 day visit)
  • bleeding on probing(During the first 1 day visit)

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Beril Aktan

Research Assistant

Izmir Katip Celebi University

研究点 (1)

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