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Oral Health and Psychosocial Factors During the Covid-19 Pandemic

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ClinicalTrials.gov Identifier: NCT04381273
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Antonio Ciardo, Heidelberg University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Covid-19 Periodontal Diseases Other: No intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Oral Health and Psychosocial Factors During the Covid-19 Pandemic
Estimated Study Start Date : May 8, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Groups and Cohorts
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Intervention Details:
  • Other: No intervention
    questionnaire-based assessment

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • <18 years old
  • Residence outside of Germany
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381273


Contacts
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Contact: Antonio Ciardo, Dr. 0049 6221 56 6020 antonio.ciardo@med.uni-heidelberg.de

Locations
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Germany
University Hospital Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Antonio Ciardo, Dr.    +496221566002    antonio.ciardo@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Investigators
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Principal Investigator: Antonio Ciardo, Dr. University Hospital Heidelberg
More Information
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Responsible Party: Dr. Antonio Ciardo, Dr. med. dent., Heidelberg University
ClinicalTrials.gov Identifier: NCT04381273    
Other Study ID Numbers: S-303/2020
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases