Oral Health and Severe COPD
Sponsor
Heidelberg University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05311657
Collaborator
(none)
104
1
20.3
5.1
Study Details
Study Description
Brief Summary
This case-control study aims to investigate the association of severe COPD with oral health.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
104 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Oral Health in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date
:
Sep 21, 2020
Actual Primary Completion Date
:
Oct 4, 2021
Anticipated Study Completion Date
:
May 31, 2022
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Test Group Severe COPD (GOLD 3 and 4). |
|
Control Group Matched to Test Group regarding age, sex, smoking history and number of systemic diseases. |
Outcome Measures
Primary Outcome Measures
- Tooth loss [one year]
Is the number of teeth different in patients with severe COPD compared to patients without COPD?
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients aged ≥ 40 years and ≤ 85 years;
-
Test group: patients with COPD GOLD 3 and 4 with available pulmonary function test values (FEV1, FVC) within the last two weeks;
-
Control group: patients without diagnosed or self-suspected pulmonary disease matched for age, sex, smoking and number of systemic diseases to the test group;
-
Understanding of measures performed in the study;
-
Written informed consent.
Exclusion Criteria:
- Pregnancy.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University Hospital Heidelberg | Heidelberg | Baden-Württemberg | Germany | 69120 |
Sponsors and Collaborators
- Heidelberg University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Dr. Antonio Ciardo,
Principal Investigator,
Heidelberg University
ClinicalTrials.gov Identifier:
NCT05311657
Other Study ID Numbers:
- S-615/2020
First Posted:
Apr 5, 2022
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: