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临床试验/NCT05590780
NCT05590780已完成不适用

Analysis of the Impact of Cell-free DNA (cfDNA) During Periodontitis and Cardiovascular Disease

University of Catania1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2019年11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
122
试验地点
1
主要终点
Clinical attachment level loss

研究概览

简要总结

The purpose of this study was to examine the association between circulating cfDNA concentration and CVD risk in patients with periodontitis, CVD, and periodontitis plus CVD. In addition, the secondary objective was to identify, among other confounders, the impact of periodontitis and cardiovascular disease as potential significant predictors of circulating cfDNA levels in the enrolled population.

详细描述

Recent emerging evidence has shown that circulating cell-free (cf) DNA are involved in in several epigenetic processes linked with periodontitis, coronary stenosis and systemic inflammation. The present study was aimed at assessing the impact of periodontitis on circulating cfDNA levels and evaluating possible confounders that influenced this association. Healthy controls (n=30) and subjects with CVD (n=31), periodontitis (n=31) and periodontitis+CVD (n=30) were enrolled. All subjects underwent regular periodontal examination and blood sampling. The analysis of the plasma cfDNA concentrations was performed using a dsDNA Assay Kit.

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
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of at least 15 teeth
  • CP with a minimum of 40% of sites with a clinical attachment level (CAL)
  • ≥2mm and probing depth (PD) ≥4mm;
  • Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
  • Presence of ≥40% sites with bleeding on probing (BOP)

排除标准

  • Intake of contraceptives
  • Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
  • Status of pregnancy or lactation
  • Previous history of excessive drinking
  • Allergy to local anaesthetic
  • Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

结局指标

主要结局

Clinical attachment level loss

时间窗: baseline changes

Evaluation of changes (in millimeters) of Clinical attachment level loss

circulating cell-free DNA

时间窗: baseline changes

Evaluation of changes (in millimeters) of plasma circulating cell-free DNA

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

Gaetano Isola

Researcher

University of Catania

研究点 (1)

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