Bergen Oral Respiratory Intervention Study

Periodontitis Clinical Trial

— BORALIS  

Official title:

The Impact of Oral Bacteria on Lung Function and Inflammation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04781153
• Other study ID #: #94605
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: December 2023
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 and lead to improved lung function.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 82
• Est. completion date: July 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Inflammation
• Lung Inflammation
• Periodontitis
• Pneumonia

Intervention

Procedure:
• Periodontal treatment
Periodontal treatment (scaling and rootplaning) with adjunctive chlorhexidine use

Locations

Country	Name	City	State
Norway	Department of Clinical Dentistry, University of Bergen	Bergen

Sponsors (3)

Lead Sponsor	Collaborator
Anders Røsland	European Research Council, Uppsala University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Vital Capacity (FVC) (L)	Change in Forced vital capacity in liters (L).	Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Primary	Forced Expiratory Volume in one second (FEV1) (L)	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
Primary	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].	Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Secondary	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.	Change from baseline at 6 months
Secondary	Fractional exhaled nitric oxide (FeNO)	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