The Impact of Oral Bacteria on Lung Function and Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Forced Vital Capacity (FVC) (L)
研究概览
简要总结
The purpose of this study is to investigate if treatment of periodontitis (gum disease) in a relatively young and healthy population can improve lung function. It is hypothesized that removing the dental biofilm reduce the source of inflammatory bacteria that can reach the lungs, and thereby reduce lung inflammation and lead to improved lung function.
详细描述
After being informed about the study and potential risks, all participants giving written informed consent will undergo a clinical screening to determine eligibility for study entry.
The study participants will be randomized into two groups. Half of the study participants will after baseline move directly into an active periodontal treatment phase including oral hygiene instructions and professional tooth cleaning by a full mouth disinfection protocol (intervention 2). New data will be collected after 6-8 weeks of healing.
The second study group will after baseline receive prophylactic periodontal treatment by oral hygiene instructions and supragingival plaque removal (intervention 1). New data will be collected after 3-4 weeks. This group will now receive the active periodontal treatment phase (intervention 2) like the first study had initially. New data will be collected after 6-8 weeks of healing.
Both groups will receive supportive periodontal treatment every 3 months in 12 months after intervention 2.
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 (Care Provider, Investigator)
盲法说明
The preventive intervention - professional tooth cleaning - cannot be blinded, but the outcome measure (lung function tests) are blinded for the operator/investigator.
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of periodontitis (stadium I or II)
- •measures of periodontal infection (PI) > 50%
- •inflammation (bleeding index/bleeding on probing) > 50%
- •never-smoker
排除标准
- •symptoms of pollen allergy
- •chronic lung diseases
- •daily medication use which may interfere with the evaluation of the subject
- •pregnancy
- •use of systemic antibiotics last six months
- •subgingival scaling last six months
- •regularly use of oral antiseptic mouth rinse
- •use of snus (moist/smokeless tobacco)
- •current medical condition which may interfere with the evaluation of the subject
结局指标
主要结局
Forced Vital Capacity (FVC) (L)
时间窗: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Change in Forced vital capacity in liters (L).
Forced Expiratory Volume in one second (FEV1) (L)
时间窗: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Change in Forced expiratory volume in one second in liters (L).
Forced Oscillation Technique (FOT)
时间窗: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Change in lung function measured by Forced Oscillation Technique (FOT). Outcome parameters are: Resistance at 5Hz (R5) \[kPaL-1s\] Resistance at 20Hz (R20) \[kPaL-1s\] Reactance at 5 Hz (X5) \[kPaL-1s\] Reactance area AX \[kPaL-1\] and Resonance frequency (fres) \[Hz\].
次要结局
- Sampling of plaque bacteria(Change from baseline at 6 months)
- Fractional exhaled nitric oxide (FeNO)(Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months)
研究者
Anders Røsland
Dentist and clinical researcher
University of Bergen