Bergen Oral Respiratory Intervention Study

Not Applicable

Completed

• Conditions: Periodontitis; Airway Obstruction; Lung Inflammation
• Interventions: Procedure: Periodontal treatment

• Registration Number: NCT04781153
• Lead Sponsor: Anders Røsland

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.

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Study Start: 2021-04-27
• Primary Completion: 2024-06-27
• Study Completion: 2024-06-27
• Status Verified: 2024-12
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate intervention (A)	Periodontal treatment	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.
Delayed intervention (B)	Periodontal treatment	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.

Primary Outcome Measures

Name	Time	Method
Forced Vital Capacity (FVC) (L)	Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months	Change in Forced vital capacity in liters (L).
Forced Expiratory Volume in one second (FEV1) (L)	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).
Forced Oscillation Technique (FOT)	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 Outcome Measures

Name	Time	Method
Sampling of plaque bacteria	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.
Fractional exhaled nitric oxide (FeNO)	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).

Trial Locations

Locations (1)

Department of Clinical Dentistry, University of Bergen; 🇳🇴 Bergen, Norway