Airway Obstruction, Lung Inflammation, Periodontitis
Conditions
Keywords
Periodontitis, Oral health, Lung function, Respiratory health, Periodontal treatment, Microbiome, Oral hygiene
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.
Interventions
PROCEDUREPeriodontal treatment
Periodontal treatment (scaling and rootplaning) with adjunctive chlorhexidine use
Sponsors
European Research Council
Uppsala University
Anders Røsland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Norway
Outcome results
None listed