COPDNCT05311657
Oral Health and Severe COPD
An observational study of COPD and Periodontitis, run by Heidelberg University at 1 site in Germany.
Trial summary
This case-control study aims to investigate the association of severe COPD with oral health. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD, Periodontitis, Caries
- How many people
- 104 participants
- Where
- 1 siteGermany
- Study dates
- 21 Sep 2020to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing routine pulmonary or dental care.
Who may be able to join
- 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.
Who cannot join
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: 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.
- Conditions
- COPD, Periodontitis, Caries, Quality of Life, Tooth Loss
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Periodontitis, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Tooth loss
Is the number of teeth different in patients with severe COPD compared to patients without COPD?
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start21 Sep 2020
- Primary completion4 Oct 2021
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio Ciardo, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311657
- Sponsor's protocol ID
- S-615/2020
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT05311657
- Acronym / sponsor ID
- S-615/2020
- Conditions
- COPD, Periodontitis, Caries, Quality of Life, Tooth Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This case-control study aims to investigate the association of severe COPD with oral health.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | – | –Severe COPD (GOLD 3 and 4). |
| Control Group | – | –Matched to Test Group regarding age, sex, smoking history and number of systemic diseases. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing routine pulmonary or dental care.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tooth loss
Time frame: one year
Is the number of teeth different in patients with severe COPD compared to patients without COPD?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Periodontitis, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth loss (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.