NCT04381273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,178

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

May 6, 2020

Last Update Submit

April 26, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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?

    08.05.2020-31.07.2020

  • Have people changed their oral hygiene practices in times of the Covid-19 pandemic?

    08.05.2020-31.07.2020

Interventions

questionnaire-based assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \<18 years old
  • Residence outside of Germany

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

MeSH Terms

Conditions

COVID-19Periodontal Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Antonio Ciardo, Dr.

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. dent.

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 8, 2020

Study Start

May 15, 2020

Primary Completion

August 8, 2020

Study Completion

August 8, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations