Bergen Oral Respiratory Intervention Study
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Airway Obstruction
- Lung Inflammation
- Periodontitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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.Masking: Double (Care Provider, Investigator)Masking Description: The preventive intervention - professional tooth cleaning - cannot be blinded, but the outcome measure (lung function tests) are blinded for the operator/investigator.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 25 years and 45 years
- Gender
- Both males and females
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 di...
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.
Tracking Information
- NCT #
- NCT04781153
- Collaborators
- European Research Council
- Uppsala University
- Investigators
- Study Chair: Randi Jacobsen Bertelsen, PhD University of Bergen
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