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Trial record 1 of 1 for:    NCT03279718
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Efficacy of Periodontal Treatment on Systemic Inflammation and for Prevention of Exacerbations in Patients With COPD (Expertention)

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ClinicalTrials.gov Identifier: NCT03279718
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Kreuter, Heidelberg University

Tracking Information
First Submitted Date  ICMJE September 7, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date May 4, 2018
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
Change in blood serum inflammatory biomarker hsCRP [ Time Frame: after 6 months and after 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03279718 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Periodontal Treatment on Systemic Inflammation and for Prevention of Exacerbations in Patients With COPD
Official Title  ICMJE Exploring Efficacy of Periodontal Treatment on Systemic Inflammation and for Prevention of Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Pilot Study
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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE COPD Exacerbation, Periodontal Health
Intervention  ICMJE Procedure: Periodontal Treatment
Scaling and root planing
Study Arms  ICMJE
  • Experimental: periodontal treatment
    Intervention: Procedure: Periodontal Treatment
  • No Intervention: only oral hygiene instruction, no treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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 Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Kreuter, Prof. 0049-(0)6221-396-1201 kreuter@uni-heidelberg.de
Contact: Claudia Bauer-Kemeny, Dr. 0049-(0)6221-396-8217 claudia.bauer@med.uni-heidelberg.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03279718
Other Study ID Numbers  ICMJE Expertention
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Kreuter, Heidelberg University
Study Sponsor  ICMJE Heidelberg University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Kreuter, Prof. Thoraxklinik, University Hospital Heidelberg
PRS Account Heidelberg University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP