Covid-19NCT04381273
Oral Health and Psychosocial Factors During the Covid-19 Pandemic
An observational study of Covid-19 and Periodontal Diseases, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid-19, Periodontal Diseases, COVID
- How many people
- 1,178 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2020to 8 Aug 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The largest possible number of people should be given the opportunity to participate in this questionnaire considered the eligibility criteria.
Who may be able to join
- ≥18 years old
- Residence in Germany
- Understanding of study participation and consent
Who cannot join
- <18 years old
- Residence outside of Germany
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
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.
- Conditions
- Covid-19, Periodontal Diseases, COVID
- Being tested
- No intervention
- Medical subject headings
- COVID-19, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
questionnaire-based assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
How do people assess their oral health-related quality of life in times of the Covid-19 pandemic?
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.
Measured: 08.05.2020-31.07.2020
Does the periodontitis risk have an influence on the severety of the Covid-19 disease and its' treatment?
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.
Measured: 08.05.2020-31.07.2020
Secondary outcomes (2)
Do psychosocial stress factors in times of the Covid-19 pandemic have an impact on their oral health related quality of life?
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.
Measured: 08.05.2020-31.07.2020
Have people changed their oral hygiene practices in times of the Covid-19 pandemic?
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.
Measured: 08.05.2020-31.07.2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start15 May 2020
- Primary completion8 Aug 2020
- Study completion8 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio Ciardo, Heidelberg University
- Investigators
- Antonio Ciardo, Dr., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381273
- Sponsor's protocol ID
- S-303/2020
- Status last verified
- Apr 2021
- First submitted
- 6 May 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health and Psychosocial Factors During the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04381273
- Acronym / sponsor ID
- S-303/2020
- Conditions
- Covid-19, Periodontal Diseases, COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,178 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 8 Aug 2020 (actual)
- Study completion
- 8 Aug 2020 (actual)
- First posted
- 8 May 2020 (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 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The largest possible number of people should be given the opportunity to participate in this questionnaire considered the eligibility criteria.
Key inclusion criteria (3 listed)
- ≥18 years old
- Residence in Germany
- Understanding of study participation and consent
Key exclusion criteria (2 listed)
- <18 years old
- Residence outside of Germany
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionquestionnaire-based assessment | Other | – |
Primary outcome
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.
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.
2 secondary outcomes
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
Have people changed their oral hygiene practices in times of the Covid-19 pandemic?
Time frame: 08.05.2020-31.07.2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Antonio Ciardo, Dr. principal investigator
University Hospital Heidelberg
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 Covid-19 and Periodontal Diseases, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 28 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 study lists 2 primary outcomes in all. 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 28 Apr 2021.