Status:
TERMINATED
Efficacy of Periodontal Treatment on Systemic Inflammation and for Prevention of Exacerbations in Patients With COPD
Lead Sponsor:
Heidelberg University
Conditions:
COPD Exacerbation, Periodontal Health
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Current data are showing a potential link between inflammatory biomarkers in chronic periodontitis and COPD. However the impact of periodontal treatment on systemic inflammation as measured by biomark...
Eligibility Criteria
Inclusion
- COPD functional class B to D (moderate to very severe) according to the Global Initiative For Chronic Obstructive Lung Disease (GOLD)
- age ≥ 40 and ≤ 80 years
- at least 10 natural teeth
- COPD-associated hsCRP elevation (after exclusion of infection) with hsCRP \> 3mg/l
- presence of chronic periodontitis
- at least 1 exacerbation leading to treatment with systemic glucocorticoids or antibiotics or hospitalization within the last 12 months
- non-smoker or ex-smoker for at least the last 6 months
- ability to understand the character and individual consequences of participation in this trial and to give written informed consent
- provision of a written informed consent to participation in the trial prior to trial start and any trial-related procedures
Exclusion
- any subgingival root-planing or any kind of periodontal surgery within the last 6 months (professional tooth cleaning is allowed)
- any antibiotics and/or systemic corticosteroid medication in the last 4 weeks before inclusion
- any antibiotics needed as prophylaxis or as an adjunct to periodontal treatment
- diagnostical bronchoscopy within the last 8 weeks
- any kind of bronchoscopy and lung surgery (volume reduction, transplantation, pneumonectomy) within the last 6 months
- concurrent participation in any interventional clinical trial (observational trials are allowed)
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03279718
Start Date
January 1 2018
End Date
October 31 2022
Last Update
November 4 2022
Active Locations (3)
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1
Clinic for Operative Dentistry, University Hospital Heidelberg
Heidelberg, Germany, 69120
2
Medical Center for Dental and Oral Medicine, Dept. of Periodontology, Philipps-University of Marburg
Marburg, Germany, 35039
3
Clinic for Internal Medicine (focus Pneumology) , University Hospital Gießen und Marburg
Marburg, Germany, 35043