跳至主要内容
临床试验/CTRI/2025/07/090063
CTRI/2025/07/090063尚未招募不适用

Assessment of cytogenic damage in chronic periodontitis and type 2 diabetes mellitus subjects through micronucleus test

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年6月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
To evaluate cytogenic damage to gingival cells in chronic periodontitis subjects and its association with diabetes.

研究概览

简要总结

This case-control study investigates the cytogenetic damage in the gingival cells of individuals with chronic periodontitis and its association with diabetes mellitus. Periodontitis, an inflammatory disease triggered by plaque biofilm, and diabetes, a metabolic disorder, share a bi-directional relationship that exacerbates both conditions. The study highlights the role of oxidative stress, reactive oxygen species (ROS), and advanced glycation end products (AGEs) in promoting inflammation, DNA damage, and tissue destruction in both diseases. Given the shared mechanisms of oxidative DNA damage and increased genotoxic stress, this study aims to evaluate the extent of cytogenetic alterations in gingival tissues, particularly in diabetic individuals with chronic periodontitis, by assessment of micronucleated and binucleated cells through the micronucleus test, to better understand the underlying pathogenic link between these two chronic conditions.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • The subject should have at least 7 or more teeth.
  • The subjects with Deep periodontal pockets greater than or equal to 6 mm in 2 non adjacent sites (or) Clinical attachment loss (CAL) greater than or equal to 4 mm in at least 4 non adjacent teeth are included for chronic periodontitis.
  • Patients with Hb A1C greater than 8 are included for diabetes. Group A- healthy subjects with no periodontitis or systemic disease Group B- chronic periodontitis with no systemic disease Group C.
  • diabetes without chronic periodontitis Group D.
  • chronic periodontitis and diabetes.

排除标准

  • Subjects with history of periodontal therapy prior to 6 months.
  • Subjects under intake of drugs such as NSAIDS, Corticosteroids, antibiotics, cytotoxic agents.
  • Subjects with systemic illness, oral lesions.
  • Subjects with any history of malignancies or radiation.
  • Subjects having viral infection or pyrexia for over past one month.
  • History of smoking or alcohol.

结局指标

主要结局

To evaluate cytogenic damage to gingival cells in chronic periodontitis subjects and its association with diabetes.

时间窗: Baseline

次要结局

未报告次要终点

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr V Vasanth Ayswarya

Priyadarshini Dental College & Hospital

研究点 (1)

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