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临床试验/NCT02619903
NCT02619903已完成不适用

The Oral Microbiota as Reservoir for Systemic Opportunistic Pathogens

Malmö University2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2016年2月1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
101
试验地点
2
主要终点
COPD exacerbations in 12 months

研究概览

简要总结

Small pilot studies with approximately 20 people per group support that eradication of the oral flora causes fewer exacerbations in chronic obstructive pulmonary disease (COPD) patients. The biological underpinning put forward is that eradicating the oral microbiome will eliminate a source of re-infection as the concentration of antibiotics prescribed to treat COPD exacerbations are not able to inhibit the bacteria in the oral biofilms that require 250 times higher concentration.

The specific aim is to investigate if adding advanced dental cleaning to COPD treatment can (i) lower the number of exacerbations and (ii) improve the COPD symptoms the coming 12 months. In an effort to explain the underpinning mechanism we will collect oral dental biofilm samples at baseline and follow up in the treatment and control group to investigate changes in the composition of the biofilm.

The subjects are selected by experienced COPD nurses. Exclusion criteria are having metastatic cancer or dementia. The COPD clinic informs the dental personal about COPD parameters, including spirometry data. At the dental clinic the patient answers a questionnaire, including a COPD assessment test (CAT) which has been validated extensively. The patients undergo a dental examination and are then randomized to test or control group. The test group go through supra- and subgingival scaling and scraping of the tongue as well as chlorhexidine rinse. The control group attends all visits.

All subjects go through the intervention after 6 months and are followed up after 12 and 24 months using questionnaire, dental plaque sampling and spirometry. The COPD nurses reviewing their medical records assess number of exacerbations.

A confirmation of the study hypothesis will be important in lowering the number of exacerbations in COPD patients, causing less suffering, less costs and less usage of antibiotics. If dental treatment is beneficial for exacerbation frequency it could be argued that dental treatment should be subsidized in this patient category.

详细描述

Introduction The dental biofilm offers a protected environment for bacteria during systemic antibiotic treatment and may consequently be a source of reinfection. The concentration of antibiotic needed for inhibiting the growth of bacteria within a dental biofilm has been estimated to be 250 times greater than for planktonically growing bacteria (1). Chronic obstructive pulmonary disease (COPD) exacerbations cause pain and discomfort for the patient, healthcare resources and an increased usage of antibiotics. Smaller studies indicate that the act of advanced dental cleaning may lower the risk of reinfected COPD, but this needs to be validated in a larger randomized study to promote clinical implications.

COPD is a growing health problem worldwide. In 2020, COPD is projected to rank fifth in terms of burden of disease and third in terms of mortality (2). Assessment of COPD is based on the patient´s level of symptoms, exacerbation history and severity of spirometric abnormality. In a randomly selected Swedish cohort, the prevalence of COPD was 16.2%, and 34% of the COPD patients had never smoked (3). Unfortunately, none of the existing medications for COPD has been shown conclusively to modify the long-term decline in lung-function, but COPD patients are usually prescribed β2-adrenerg receptor agonists and anticholinergics (2). For acute exacerbations, the patients have oral steroids and antibiotics, typically doxycycline and amoxicillin. Importantly, two smaller (n=20 per group) pilot studies (4,5) have reported a lower frequency of exacerbations in COPD patients that have received advanced dental cleaning, suggesting that the oral microbiome might constitute a reservoir that infects the lungs in COPD. There is a need of studies based on larger cohorts in order to claim that dental treatment should be added to the treatment regime of COPD, to decrease the frequencies of exacerbations and thereby minimize physical suffering as well as related costs.

Hypothesis The hypothesis of this project is that adding advanced dental cleaning to established COPD treatment regime delays and lowers the frequency of exacerbations by eliminating a source of reinfections.

Aim The overall aim of this project is to investigate if the treatment of COPD can be optimized by adding advanced dental cleaning to the established treatment regime and thereby eliminate a source of reinfections.

The specific aim is to investigate if adding advanced dental cleaning to COPD treatment can (i) lower the number of exacerbations and (ii) improve the COPD symptoms the coming 6 and 12 months. In an effort to explain the underpinning mechanism we will collect oral dental biofilm samples at baseline and follow up in the treatment and control group to investigate changes in the composition of the biofilm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD arm - COPD Gold standard 1-4.

排除标准

  • Physically unable to make it to the dental clinic.

结局指标

主要结局

COPD exacerbations in 12 months

时间窗: 12 months

We will ask the patients how many exacerbations they had and go through medical records.

次要结局

  • COPD symptoms(12 months)

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

Assistant professor

Malmö University

研究点 (2)

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