Oral Health and Psychosocial Factors During the Covid-19 Pandemic

April 26, 2021 updated by: Dr. Antonio Ciardo, Heidelberg University
This prospective observational study examines the effects of the Covid-19 pandemic on oral health, taking psychosocial factors into account, and the possible impact of a high periodontitis risk on the severity of the need for treatment in Covid-19 patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1178

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The largest possible number of people should be given the opportunity to participate in this questionnaire considered the eligibility criteria.

Description

Inclusion Criteria:

  • ≥18 years old
  • Residence in Germany
  • Understanding of study participation and consent

Exclusion Criteria:

  • <18 years old
  • Residence outside of Germany

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
How do people assess their oral health-related quality of life in times of the Covid-19 pandemic?
Time Frame: 08.05.2020-31.07.2020
The survey consists of validated and unvalidated items giving the opportunity to assess periodontitis risk, psychosocial stress, anxiety, depression and oral health related quality of life as well as questions focusing on experiences of the covid-19 pandemic.
08.05.2020-31.07.2020
Does the periodontitis risk have an influence on the severety of the Covid-19 disease and its' treatment?
Time Frame: 08.05.2020-31.07.2020
The survey consists of validated and unvalidated items giving the opportunity to assess periodontitis risk, psychosocial stress, anxiety, depression and oral health related quality of life as well as questions focusing on experiences of the covid-19 pandemic.
08.05.2020-31.07.2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Do psychosocial stress factors in times of the Covid-19 pandemic have an impact on their oral health related quality of life?
Time Frame: 08.05.2020-31.07.2020
The survey consists of validated and unvalidated items giving the opportunity to assess periodontitis risk, psychosocial stress, anxiety, depression and oral health related quality of life as well as questions focusing on experiences of the covid-19 pandemic.
08.05.2020-31.07.2020
Have people changed their oral hygiene practices in times of the Covid-19 pandemic?
Time Frame: 08.05.2020-31.07.2020
The survey consists of validated and unvalidated items giving the opportunity to assess periodontitis risk, psychosocial stress, anxiety, depression and oral health related quality of life as well as questions focusing on experiences of the covid-19 pandemic.
08.05.2020-31.07.2020

Collaborators and Investigators

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

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Antonio Ciardo, Dr., University Hospital Heidelberg

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)

May 15, 2020

Primary Completion (ACTUAL)

August 8, 2020

Study Completion (ACTUAL)

August 8, 2020

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (ACTUAL)

May 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-303/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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