跳至主要内容
临床试验/NCT06906510
NCT06906510已完成不适用

Evaluation of Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease

Ankara Medipol University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年1月8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
48
试验地点
1
主要终点
Plaque index (PI)

研究概览

简要总结

Salivary and serum levels of TMAO and TNF-α can distinguish between individuals with periodontitis and periodontally healthy individuals.

详细描述

Trimethylamine N-oxide (TMAO), a gut flora-derived metabolite from dietary choline, has emerged as an indicator of atherosclerosis. Circulatory TMAO has been implicated in cardiovascular risks by altering enterohepatic cholesterol and bile acid metabolism, increasing macrophage scavenger receptor expression, and activating nuclear factor kappa B (NF-κB) via pro-inflammatory genes such as interleukin-1 (IL-1). The pro-inflammatory cytokine tumor necrosis factor-alpha (TNF-α), which plays a crucial role in immune responses and inflammation, has been demonstrated as a crucial participant also during the development of periodontal diseases. The aim of this study is to evaluate difference in salivary and serum levels of TMAO and TNF-α between individuals with periodontitis and periodontally healthy individuals.

The study includes two groups: systemically and periodontally healthy control subjects (n= 24), and patients with periodontitis (n=24). Periodontal parameters were recorded. TMAO levels in saliva and serum were determined by liquid chromatography-mass spectrometry (LC-MS/MS), and TNF-α levels were determined by ELISA.

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

  • being over 18 and under 65 years of age;
  • having at least 20 natural teeth excluding the third molars; and
  • being systemically healthy.

排除标准

  • being smoker;
  • chronic use of any systemic medication
  • use of antibiotics and/or anti-inflammatory steroids, nonsteroidal anti-inflammatory drugs, immunosuppressants, beta-blockers, calcium channel blockers, anticoagulants, or hormonal contraceptives within 3 months preceding the study;
  • pregnancy or lactation; and
  • use of orthodontic appliances

结局指标

主要结局

Plaque index (PI)

时间窗: Baseline

Clinical parameters such as Probing depth (PD), Plaque index (PI), Bleeding on probing (BOP), and Clinical attachment loss (CAL) were recorded.

Probing depth (PD)

时间窗: Baseline

Clinical parameters such as Probing depth (PD), Plaque index (PI), Bleeding on probing (BOP), and Clinical attachment loss (CAL) were recorded.

Bleeding on probing (BOP)

时间窗: Baseline

Clinical parameters such as Probing depth (PD), Plaque index (PI), Bleeding on probing (BOP), and Clinical attachment loss (CAL) were recorded.

Clinical attachment loss (CAL)

时间窗: Baseline

Clinical parameters such as Probing depth (PD), Plaque index (PI), Bleeding on probing (BOP), and Clinical attachment loss (CAL) were recorded.

Age

时间窗: Baseline

次要结局

  • Salivary and serum TMAO(Baseline)
  • Salivary and serum TNF-α levels(Baseline)

研究者

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

Ceyhan CERAN SERDAR

Assistant Prof.

Ankara Medipol University

研究点 (1)

Loading locations...

相似试验