Efficacy of Periodontal Treatment on Systemic Inflammation and for Prevention of Exacerbations in Patients With COPD (Expertention)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03279718|
Recruitment Status : Not yet recruiting
First Posted : September 12, 2017
Last Update Posted : November 13, 2017
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 biomarkers and time to occurrence of acute exacerbations (AECOPD) remains an important but unresolved issue. This pilot study will provide information on effects of periodontal treatment on systemic inflammation and the course of COPD including acute exacerbation.
40 patients with chronic periodontitis and COPD will be included in this study. First baseline information (age, gender, lifestyle, smoking history, medical history, medication, frequency of exacerbation, dental treatments) are recorded. Then patient's health status is assessed using the COPD Assessment Test (CAT) and a comprehensive lung function testing (bodyplethysmograph) is conducted to assess lung functional severity of COPD. Blood samples are taken for analysis of various inflammatory biomarkers and saliva and sputum samples are collected for analysis of microbiome.
Afterwards experienced dentists will conduct oral health examination and record the periodontal conditions of every patient. Samples of gingival crevicular fluid for determining Matrix metallopeptidase 8 (MMP8), Interleukin 1 beta (IL-1beta) and Interleukin 6 (IL-69 levels and for microbiome analysis will be taken. After randomization to one of the two study groups (intervention group: periodontal treatment / control group: no periodontal treatment) all patients get comprehensive oral hygiene instructions, irrespective of their periodontal status . Patients of the control group receive no further planned dental intervention. For patients of the experimental group, who need periodontal treatment due to the presence of periodontal pocket depth of ≥ 4 mm an appropriate care plan will be determined and supra- and subgingival scaling and root planing will be performed.
During a 3, 6 and 12 months follow-up patient's current health condition will be assessed using the CAT. Additionally lung function tests (bodyplethysmograph) will be performed and clinical periodontal parameters are re-evaluated. To detect and assess COPD exacerbations in this trial, patients will complete a daily diary during the whole follow-up period which will be provided to the clinical researcher at each study visit. Furthermore the cough and sputum assessment questionnaire (CASA-Q)) will be used at each telephone call and at each visit in the pulmonary center. After 6 and 12 months blood, sputum, saliva and gingival crevicular fluid will be taken additionally. To understand the microbial ecology mechanisms linking periodontitis to COPD combined analysis of oral cavity microbiome (GCF) and lung microbiome (sputum) will be conducted. The biomarkers high sensitive C-reactive Protein (hsCRP), MMP8, IL-1beta und IL-6 will be determined in blood and in gingival crevicular fluid, respectively.
|Condition or disease||Intervention/treatment||Phase|
|COPD Exacerbation, Periodontal Health||Procedure: Periodontal Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploring Efficacy of Periodontal Treatment on Systemic Inflammation and for Prevention of Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Pilot Study|
|Estimated Study Start Date :||November 15, 2017|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||March 31, 2020|
|Experimental: periodontal treatment||
Procedure: Periodontal Treatment
Scaling and root planing
|No Intervention: only oral hygiene instruction, no treatment|
- Change in blood serum inflammatory biomarker hsCRP [ Time Frame: after 6 months and after 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279718
|Contact: Michael Kreuter, Prof.||0049-(0)firstname.lastname@example.org|
|Contact: Claudia Bauer-Kemeny, Dr.||0049-(0)email@example.com|
|Clinic for Operative Dentistry, University Hospital Heidelberg||Not yet recruiting|
|Heidelberg, Germany, 69120|
|Contact: Ti-Sun Kim, Prof. 06221/56-6002 Ji-Sun.Kim@med.uni-heidelberg.de|
|Medical Center for Dental and Oral Medicine, Dept. of Periodontology, Philipps-University of Marburg||Not yet recruiting|
|Marburg, Germany, 35039|
|Contact: Nicole Arweiler, Prof. 06421/5863279 firstname.lastname@example.org|
|Clinic for Internal Medicine (focus Pneumology) , University Hospital Gießen und Marburg||Not yet recruiting|
|Marburg, Germany, 35043|
|Contact: Claus Vogelmeier, Prof. 06421/58-66451 email@example.com|
|Principal Investigator:||Michael Kreuter, Prof.||Thoraxklinik, University Hospital Heidelberg|