The Impact of Oral Bacteria on Lung Function and Inflammation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Forced Vital Capacity (FVC) (L)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Care Provider, Investigator)
Masking Description
The preventive intervention - professional tooth cleaning - cannot be blinded, but the outcome measure (lung function tests) are blinded for the operator/investigator.
Eligibility Criteria
- Ages
- 25 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinical diagnosis of periodontitis (stadium I or II)
- •measures of periodontal infection (PI) > 50%
- •inflammation (bleeding index/bleeding on probing) > 50%
- •never-smoker
Exclusion Criteria
- •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
Arms & Interventions
Immediate intervention (A)
Subjects will receive the full mouth disinfection treatment protocol (scaling and rootplaning of all periodontal pockets with adjunctive use of chlorhexidine mouthwash) immediately after baseline.
Intervention: Periodontal treatment (Procedure)
Delayed intervention (B)
Subjects will receive a full mouth disinfection treatment protocol (scaling and rootplaning of all periodontal pockets with adjunctive use of chlorhexidine mouthwash) 3-4 weeks after baseline. The "delayed intervention" will enable the study team to explore the effect of the participants change in behavior due to participation in a research project, and furthermore how change in oral hygiene habits might affect the lung function.
Intervention: Periodontal treatment (Procedure)
Outcomes
Primary Outcomes
Forced Vital Capacity (FVC) (L)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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) \[Hz\].
Secondary Outcomes
- 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)
Investigators
Anders Røsland
Dentist and clinical researcher
University of Bergen