Bergen Oral Respiratory Intervention Study (BORALIS)

February 3, 2025 updated by: Anders Røsland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5009
        • Department of Clinical Dentistry, University of Bergen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Periodontal treatment
Periodontal treatment (scaling and rootplaning) with adjunctive chlorhexidine use
Experimental: 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.
Procedure: Periodontal treatment
Periodontal treatment (scaling and rootplaning) with adjunctive chlorhexidine use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
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).
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
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].
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at 6 months
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).
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anders Røsland

Collaborators

Uppsala University
European Research Council

Investigators

  • Study Chair: Randi Jacobsen Bertelsen, PhD, University of Bergen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2021

Primary Completion (Actual)

June 27, 2024

Study Completion (Actual)

June 27, 2024

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #94605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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