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Completed

NCT Number: NCT04781153

Bergen Oral Respiratory Intervention Study

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.

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Key information

Conditions

Periodontitis Airway Obstruction Infections Lung Diseases Lung Inflammation Mouth Diseases Periodontal Diseases Pneumonia Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Dentistry, University of Bergen

Bergen, BERGEN, 5009, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periodontal Treatment

Procedure

Periodontal treatment (scaling and rootplaning) with adjunctive chlorhexidine use

Primary outcomes

  1. 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).

  2. 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).

  3. 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

  1. Sampling of plaque bacteria

    Time frame: Change from baseline at 6 months

    Saliva and plaque collected at inclusion and from each follow-up will be analyzed with high-throughput sequencing techniques to characterize the bacteria that are present. Bacterial DNA will be isolated from the samples and the 16S rRNA bacterial gene will be amplified and sequenced by Illumina® MiSeq platforms. Shotgun sequencing will also be applied on a subsample to allow full resolution and identification of bacteria at species and subspecies taxonomic level.

  2. Fractional exhaled nitric oxide (FeNO)

    Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months

    Change in FeNO at exhalation flow-rate of 50 mL/s, measured in parts per billion (ppb).

Sponsors and collaborators

Lead sponsor

Anders Røsland

Other

Collaborators

  • European Research Council
  • Uppsala University

Registry information

Official study title

The Impact of Oral Bacteria on Lung Function and Inflammation

Acronym: BORALIS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2021
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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