Oral Health and Severe COPD | NCT05311657

Studies
Oral Health and Severe COPD

NCT05311657

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Apr 5, 2022Actual

Enrollment

104Actual

Phase

Not provided

Conditions

COPD
Periodontitis
Caries
Quality of Life
Tooth Loss

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2020Actual

Primary Completion Date

Oct 4, 2021Actual

Completion Date

May 31, 2022Estimated

First Submitted Date

Mar 23, 2022

First Submission Date that Met QC Criteria

Apr 4, 2022

First Posted Date

Apr 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2022

Last Update Posted Date

Apr 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Group		Severe COPD (GOLD 3 and 4).
Control Group		Matched to Test Group regarding age, sex, smoking history and number of systemic diseases.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing routine pulmonary or dental care.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Heidelberg		Heidelberg	Baden-Wurttemberg	69120	Germany

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D010518	Periodontitis
D016388	Tooth Loss

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided