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临床试验/NCT04565691
NCT04565691进行中(未招募)不适用

Bacteremia From Periodontal Treatment to Elucidate the Underpinnings of Sepsis

Malmö University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年2月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Bacteremia

研究概览

简要总结

Approximately 40,000 Swedes suffer from sepsiseach year, about 20% die. Biomarkers that are sensitive to current or previous bacteremia are needed in the treatment of sepsis. Bacteremia from periodontal treatment is predictive and occurs in 13-75%. Cardiovascular disease (CVD) is the number one cause of death in industrialized countries and the impact of bacteria and their products need to be elucidated.

The study's hypothesis is to utilize bacteremia from periodontal treatment to evaluate biological markers for current or previous bacteremia.

A. What are the long term clinical, and 'omics related CVD-phenotypical effects from treating periodontal disease compared to an untreated group? B. Can biomarkers be used for detecting a bacteremia or previous bacteremia? C. Are the effects from bacteremia on cardiovascular biomarkers related to the individual's antimicrobial peptide profile? D. Does the presence of bacterial proteases, such as gingipain, relate to having a bacteremia from periodontal treatment and the systemic response from a bacteremia?

Significance: The project has the potential to shorten the time to treat sepsis, which in turn shortens hospital stay and higher survival. The possible definition of protective AMP-profile could translate to future pharmacologic intervention and improve the treatment of sepsis as well as prophylactic treatment at dental treatments. An elucidation of the impact of bacteria and their products on CVD could lead to personalized medicine targeting anti-inflammation and anti-oxidative stress in subjects with periodontitis.

As of March 2024 78 subjects have been included and we anticipate to keep the time-line that we set up.

详细描述

Bacteremia from periodontal treatment to elucidate the underpinnings of sepsis

Hypothesis In the context of cardiovascular disease (CVD) and sepsis this study hypothesise that (1) periodontal disease causes a specific CVD phenotype that can, to some extent, be reversed by treating periodontal disease; (2) that non-surgical periodontal treatment can be used as a human bacteremia model for evaluating biomarkers that can be used in the sepsis clinic; (3) that endogenous antimicrobial peptide profile dictate the severity of a bacteremia; (4) that proteinases from the oral biofilm can impact the severity of a bacteremia induced by oral bacteria and their products.

Aims A. What are the long term clinical, and 'omics related CVD-phenotypical effects from treating periodontal disease compared to an untreated group? B. Can biomarkers be used for detecting a bacteremia or previous bacteremia? C. Are the effects from bacteremia on cardiovascular biomarkers related to the individual's antimicrobial peptide profile? D. Does the presence of bacterial proteases, such as gingipain, relate to having a bacteremia from periodontal treatment and the systemic response from a bacteremia?

Project description To answer the clinical problems from the dental chair and the sepsis intensity care unit the investigators have designed the Bacteremia Study. Aim 1 is an intervention study, while Aim 2 and 3 are investigating the pathophysiological underpinnings of the association. When studying the long term effects of periodontal treatment on CVD phenotype Malmö Offspring Dental Study (MODS) participants who have not sought dental care despite being told they have periodontal disease, will be invited as non-treated controls. The primary outcome variable will be changes in total carotid plaque area (TPA) per year.

In Aim 2 and 3 the parameters used to dissect the different aspects of the bacteremia. The AMP profile may be different in subjects with more severe bacteremia (measured by blood culturing) versus no bacteremia. The primary outcome will be concentration of CVD biomarkers during and following bacteremia (positive blood culture) compared to those who have negative blood culture.

研究设计

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

盲法说明

No masking.

入排标准

性别
All
接受健康志愿者

入选标准

  • Periodontal disease

排除标准

  • Recently used antibiotics.

研究组 & 干预措施

Bacteremia inducing arm

Experimental

As mentioned the participants will be their own controls at the different time-points.

干预措施: Non-surgical periodontal treatment (Procedure)

结局指标

主要结局

Bacteremia

时间窗: At baseline, periodontal treatment (within 5 min) and 1 hour, 1 day, 1 week and 1 year after periodontal treatment.

Changes in positive blood culture

次要结局

  • Changes in levels of biomarkers in relation to bacteremia(At baseline, periodontal treatment (within 5 min) and 1 hour, 1 day, 1 week and 1 year after periodontal treatment.)

研究者

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

Daniel Joensson

Associate Professor

Malmö University

研究点 (1)

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