Bergen Oral Respiratory Intervention Study (BORALIS)

Anders Røsland

Status: Completed

Conditions: Periodontitis; Lung Inflammation; Airway Obstruction

Treatments: Procedure: Periodontal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04781153

#94605

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups

Immediate intervention (A)

Experimental group

Description:

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.

Treatment:

Procedure: Periodontal treatment

Delayed intervention (B)

Experimental group

Description:

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.

Treatment:

Procedure: Periodontal treatment