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临床试验/NCT06554756
NCT06554756已完成不适用

Annexin Levels in GCF Determine the Imbalance of Periodontal Inflammatory Regulation

Medipol University2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2023年5月15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
50
试验地点
2
主要终点
Pocket probing depth

研究概览

简要总结

ANXA1, a member of the annexin family, plays a role in the resolution of inflammation and the regulation of anti-inflammatory responses, while ANXA2 is involved in the initiation of the inflammatory responses. The aim of this study was to determine the effects of annexin family (ANXA1 and ANXA2) in periodontal disease.

详细描述

Healthy participants (n:25) and stage III, grade B periodontitis (n:25) patients enrolled for this study. Clinical periodontal parameters and PISA levels were noted. Serum, saliva, and GCF samples were collected to measure the ANXA1, ANXA2 and IL-1β levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

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
  • clinical diagnosis of periodontitis
  • clinical diagnosis of periodontal health

排除标准

  • • history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)
  • nonsurgical periodontal treatment (previous 6 months)
  • surgical periodontal treatment (previous 12 months)
  • presence of<10 teeth
  • current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
  • diagnosis of rheumatoid arthritis
  • pregnancy
  • lactating
  • excessive alcohol consumption.

结局指标

主要结局

Pocket probing depth

时间窗: 6 months

Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.

Clinical attachment level

时间窗: 6 months

Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ. To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth. In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract)

Bleeding on probing

时间窗: 6 months

referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.

次要结局

  • Saliva, serum and GCF samples processing and analyses(1 month)

研究者

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

Melis Yilmaz

Associate Prof Dr

Medipol University

研究点 (2)

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