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临床试验/NCT06516328
NCT06516328已完成不适用

AGE/sRAGE and IL-17 Levels in Type 2 Diabetic Periodontitis Patients

Hacettepe University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
AGEs/RAGE ratio, IL-17 level in GCF and saliva

研究概览

简要总结

The goal of this observational study is to learn about some molecules in the disease mechanism of type 2 diabetes and periodontitis. There are end products inside the body called AGEs and their receptors binding to them especially (sRAGE, RAGE) in people with diabetes in hyperglycemic state.These molecules are important also in periodontitis (the disease of teeth that may end with exfoliation of the tooth). Diabetes and periodontitis enhance each other's disease-causing effects. Both is chronic inflammatory diseases and IL-17 is another molecule having role in this process.

Totally 64 men and women aged between 27-60 included in the study. Study groups were : 1.participants with healthy teeth and no diabetes, 2. participants with periodontitis without diabetes, 3.participants with periodontitis and controlled diabetes, 4.participants with periodontitis and uncontrolled diabetes (6.5% and fasting blood sugar levels <200 mg/dl). Researchers got saliva and gingival crevicular fluid (GCF) samples from diseased teeth and examined AGE, sRAGE, IL-17 levels. GCF is a fluid around the crevice of the theeth with different characteristics from saliva.

As a result AGE/sRAGE ratio and IL-17 levels of diseased groups were higher than healthy group, while sRAGE levels were significantly lower in GCF samples. Researchers concluded that GCF and saliva AGE/sRAGE ratio may represent as a biomarker in periodontitis patients with uncontrolled diabetes.

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
25 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having interdental attachment loss in at least two non-adjacent teeth, or with >3 mm of attachment loss in the buccal or palatal/lingual region with >3 mm probing depth in at least two teeth for periodontitis groups.
  • Having minimum 5mm or more pocket depth in at least 6 periodontal pockets.
  • HbA1c value ≤ 6.5% and fasting blood sugar levels <200 mg/dl for the controlled diabetes group.
  • HbA1c value > 6.5% and fasting blood sugar levels > 200 mg/dl for uncontrolled diabetes group.

排除标准

  • having periodontal treatment in the last six months;
  • participants with smoking habit or history; and
  • usage of medicine that may affect study results (mouthwash, antibiotics, corticosteroid, statins etc.) three months before collecting dental plaque and GCF samples.
  • Lactating or pregnant patients
  • Patients with systemic diseases other than type 2 diabetes.

结局指标

主要结局

AGEs/RAGE ratio, IL-17 level in GCF and saliva

时间窗: 3 to 6 months

IL-17 level comparison between study groups

次要结局

未报告次要终点

研究者

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

Yagmur Deniz YILDIRIM

Asistant Proffessor

Hacettepe University

研究点 (1)

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