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临床试验/NCT07755228
NCT07755228已完成不适用

Salivary Gasdermin E and Granzyme B Levels in Patients With Periodontitis

Medipol University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2026年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
Salivary Gasdermin E Concentration

研究概览

简要总结

This observational study aims to compare salivary Gasdermin E and Granzyme B levels between individuals with periodontitis and periodontally healthy individuals. It will also evaluate the relationships between these biomarkers and clinical periodontal measurements. Saliva samples and periodontal clinical measurements will be collected from all participants. No treatment or experimental intervention will be administered as part of the study. The findings may contribute to a better understanding of the inflammatory mechanisms associated with periodontitis.

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

  • Individuals aged 18 to 65 years
  • Presence of at least 20 natural teeth, excluding third molars
  • Being systemically healthy
  • Provision of written informed consent
  • For the periodontitis group, diagnosis of generalized Stage III Grade B periodontitis according to the 2017 AAP/EFP classification
  • Clinical attachment loss of at least 2 mm at two or more non-adjacent teeth for the periodontitis group
  • Interdental clinical attachment loss of at least 5 mm and periodontitis-related loss of no more than four teeth for Stage III periodontitis
  • A radiographic bone loss-to-age ratio between 0.25 and 1.00 for Grade B periodontitis
  • For the healthy control group, an intact periodontium, probing depth of 3 mm or less, and bleeding on probing at less than 10% of sites

排除标准

  • Use of antibiotics, antimicrobial agents, nonsteroidal anti-inflammatory drugs, steroids, immunosuppressants, beta-blockers, calcium channel blockers, anticoagulants, or hormonal contraceptives within the previous 3 months
  • Periodontal treatment within the previous 6 months
  • Surgical periodontal treatment within the previous 12 months
  • Current smoking
  • Pregnancy or breastfeeding
  • Presence of any neurological, autoimmune, metabolic, inflammatory, or other systemic condition that could affect the immune response
  • Use of an orthodontic appliance

结局指标

主要结局

Salivary Gasdermin E Concentration

时间窗: At baseline (single study visit)

Gasdermin E concentration in unstimulated whole saliva samples will be measured using an enzyme-linked immunosorbent assay (ELISA) and compared between the periodontitis and periodontally healthy groups.

Salivary Granzyme B Concentration

时间窗: At baseline (single study visit)

Granzyme B concentration in unstimulated whole saliva samples will be measured using an enzyme-linked immunosorbent assay (ELISA) and compared between the periodontitis and periodontally healthy groups.

次要结局

  • Correlation Between Salivary Gasdermin E Levels and Clinical Periodontal Parameters(At baseline (single study visit))
  • Correlation Between Salivary Granzyme B Levels and Clinical Periodontal Parameters(At baseline (single study visit))

研究者

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

Merve Can

Assistant Prof Dr.

Medipol University

研究点 (1)

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