Clinical trial NCT04781153: Bergen Oral Respiratory Intervention Study
Official title: The Impact of Oral Bacteria on Lung Function and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Airway Obstruction
Lung Inflammation
Keywords: Periodontitis
Oral health
Lung function
Respiratory health
Periodontal treatment
Microbiome
Oral hygiene
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: European Research Council
name: Uppsala University
First posted: 2021-03-04
Enrollment: 62
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blinded longitudinal intervention study with two study groups. The participants will act as their own control as they enter the study with the same periodontal diagnose and receive the same periodontal treatment during the study period. The study does not aim to explore the effect of the periodontal treatment itself, but how removal of oral bacteria affects lung function. After randomization the participants in the first study arm will be moved directly into an active periodontal treatment phase including a scaling and rootplaning with adjunctive chlorhexidine. The second study arm will receive the intervention 3-4 weeks after the first study group - as a "delayed intervention group". At the first appointment they will receive prophylactic periodontal treatment and oral hygiene instructions. This will enable comparison between the immediate intervention group with the delayed intervention (oral hygiene motivation), which serves as the control group.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

* asthma
* 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

Primary outcomes:
measure: Forced Vital Capacity (FVC) (L)
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
measure: Forced Expiratory Volume in one second (FEV1) (L)
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
measure: Forced Oscillation Technique (FOT)
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Secondary outcomes:
measure: Sampling of plaque bacteria
timeFrame: Change from baseline at 6 months
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Clinical Dentistry, University of Bergen
Study officials:
affiliation: University of Bergen
name: Randi Jacobsen Bertelsen, PhD
role: STUDY_CHAIR
References: