Oral Health and Severe COPD

Sponsor
Heidelberg University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05311657
Collaborator
(none)
104
Enrollment
1
Location
20.3
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This case-control study aims to investigate the association of severe COPD with oral health.

Condition or DiseaseIntervention/TreatmentPhase

    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

    ArmIntervention/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

    1. 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

    SiteCityStateCountryPostal Code
    1University Hospital HeidelbergHeidelbergBaden-WürttembergGermany69120

    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:

    Study Results

    No Results Posted as of Apr 5, 2022