Oral Health and Severe COPD

April 4, 2022 updated by: Dr. Antonio Ciardo, Heidelberg University

Oral Health in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)

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

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • University Hospital Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing routine pulmonary or dental care.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Test Group
Severe COPD (GOLD 3 and 4).
Control Group
Matched to Test Group regarding age, sex, smoking history and number of systemic diseases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth loss
Time Frame: one year
Is the number of teeth different in patients with severe COPD compared to patients without COPD?
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2020

Primary Completion (Actual)

October 4, 2021

Study Completion (Anticipated)

May 31, 2022

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-615/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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