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PeriodontitisBORALISNCT04781153

Bergen Oral Respiratory Intervention Study

A study testing Periodontal treatment in people with Periodontitis and Airway Obstruction, run by Anders Røsland at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 25 to 45 years
What is being tested?
Periodontal treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteNorway
Study dates
27 Apr 2021to 27 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • clinical diagnosis of periodontitis (stadium I or II)
  • measures of periodontal infection (PI) > 50%
  • inflammation (bleeding index/bleeding on probing) > 50%
  • never-smoker

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Department of Clinical Dentistry, University of Bergen

    Bergen, BERGEN, 5009

Other trials in Norway

About this study

Official title: The Impact of Oral Bacteria on Lung Function and Inflammation

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.

Read the 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.

Being tested
Periodontal treatment
Keywords
Periodontitis, Oral health, Lung function, Respiratory health, Periodontal treatment, Microbiome, Oral hygiene
Medical subject headings
Periodontitis, Airway Obstruction, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Periodontal treatmentProcedure or surgery

    Periodontal treatment (scaling and rootplaning) with adjunctive chlorhexidine use

Study groups in NCT04781153
Study groupRoleWhat they receive
Immediate intervention (A)ExperimentalSubjects will receive the full mouth disinfection treatment protocol (scaling and rootplaning of all periodontal pockets with adjunctive use of chlorhexidine mouthwash) immediately after baseline.
Receives: Procedure: Periodontal treatment
Delayed intervention (B)ExperimentalSubjects 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.
Receives: Procedure: Periodontal treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Forced Vital Capacity (FVC) (L)

    Change in Forced vital capacity in liters (L).

    Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months

  2. Forced Expiratory Volume in one second (FEV1) (L)

    Change in Forced expiratory volume in one second in liters (L).

    Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months

  3. Forced Oscillation Technique (FOT)

    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].

    Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months

Secondary outcomes (2)

  1. Sampling of plaque bacteria

    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.

    Measured: Change from baseline at 6 months

  2. Fractional exhaled nitric oxide (FeNO)

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

    Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2021
  2. Study start27 Apr 2021
  3. Primary completion27 Jun 2024
  4. Study completion27 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04781153
Sponsor's protocol ID
#94605
Acronym
BORALIS
Status last verified
Dec 2024
First submitted
19 Feb 2021
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to the relatively small number of participants that will be enrolled in the present study, we cannot make individual participant data openly available. However, other researcher can contact us if they are interested in discussing the possibility of getting access to the data.

Publications

  • Rosland A, Bertelsen RJ, Heinrich J, Lie SA, Malinovschi A, Bunaes DF. Effect of periodontal therapy on lung function: a twelve-month follow-up intervention study. Respir Res. 2025 May 3;26(1):172. doi: 10.1186/s12931-025-03246-1.

    PubMed 40319277

Questions about this trial

What is this clinical trial studying?

A study testing Periodontal treatment in people with Periodontitis and Airway Obstruction, run by Anders Røsland at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced Vital Capacity (FVC) (L) (time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04781153, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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