Bergen Oral Respiratory Intervention Study

NCT04781153 | Completed

• 1 other identifier: #94605
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Airway Obstruction; Lung Inflammation

Keywords

Periodontitis; Oral health; Lung function; Respiratory health; Periodontal treatment; Microbiome; Oral hygiene

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Sampling of plaque bacteria

  Change from baseline at 6 months

• Fractional exhaled nitric oxide (FeNO)

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

Study Arms (2)

Immediate intervention (A)

EXPERIMENTAL

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

Delayed intervention (B)

EXPERIMENTAL

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

Interventions

Periodontal treatment PROCEDURE

Periodontal treatment (scaling and rootplaning) with adjunctive chlorhexidine use

Delayed intervention (B); Immediate intervention (A)

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anders Røsland: lead
• European Research Council: collaborator
• Uppsala University: collaborator

Study Sites (1)

Department of Clinical Dentistry, University of Bergen

Bergen, BERGEN, 5009, Norway

Location

Related Publications (1)

• 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.

  PMID: 40319277 DERIVED

MeSH Terms

Conditions

Periodontitis; Airway Obstruction; Pneumonia

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry

Study Officials

• Randi Jacobsen Bertelsen, PhD

  University of Bergen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The preventive intervention - professional tooth cleaning - cannot be blinded, but the outcome measure (lung function tests) are blinded for the operator/investigator.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dentist and clinical researcher

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 4, 2021
• Study Start: April 27, 2021
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: February 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)