NCT04706156

Brief Summary

This study is a multicenter cross-sectional survey-based study conducted in four European countries (Czech Republic, Germany, Slovak Republic, and Turkey). An online questionnaire will be utilized to collect data from volunteer subjects following the STROBE reporting guidelines of cross-sectional studies.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
3 countries

4 active sites

Status
unknown

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

January 11, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

January 27, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

February 25, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

January 11, 2021

Last Update Submit

February 23, 2021

Conditions

Oral ManifestationsCovid19Vaccine Adverse Reaction

Keywords

COVID19Oral ManifestationsVaccine Adverse Reaction

Outcome Measures

Primary Outcomes (1)

  • Oral Side Effects

    Dichotomous outcome for the emergence of oral side effects (e.g. ulcers, vesicles, blisters, plaque, mouth odour, bleeding gum, burning gingiva, etc) following receiving the COVID-19 vaccine.

    0-30 days after the COVID-19 vaccine shot

Secondary Outcomes (2)

  • Dermatologic Side Effects

    0-30 days after the COVID-19 vaccine shot

  • General (common) Side Effects

    0-30 days after the COVID-19 vaccine shot

Study Arms (4)

Vaccinated Healthcare Workers (CZ)

Czech healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)

Biological: COVID-19 Vaccine

Vaccinated Healthcare Workers (DE)

German healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)

Biological: COVID-19 Vaccine

Vaccinated Healthcare Workers (SK)

Slovak healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)

Biological: COVID-19 Vaccine

Vaccinated Healthcare Workers (TR)

Turkish healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)

Biological: COVID-19 Vaccine

Interventions

COVID-19 VaccineBIOLOGICAL

Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine

Vaccinated Healthcare Workers (CZ)Vaccinated Healthcare Workers (DE)Vaccinated Healthcare Workers (SK)Vaccinated Healthcare Workers (TR)

Eligibility Criteria

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

The target population is healthcare workers as they are identified among the priority groups of COVID-19 vaccine deployment plans in the EU/EEA and the UK. One more reason to select the healthcare workers among different groups of the population, their higher awareness about the possible vaccine-related oral side-effects so that more accurate and reliable results can be obtained.

You may qualify if:

  • Healthcare workers who received COVID-19 vaccine during the last 30 days.
  • Participating subjects should be at least 18-year-old and able to give their informed consent independently.

You may not qualify if:

  • The healthcare workers who did not receive the COVID-19 vaccine recently.
  • Non-healthcare workers who received the COVID-19 vaccine recently.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Public Health, Faculty of Medicine, Masaryk University

Brno, South-Moravia, 625 00, Czechia

RECRUITING

Department of Cranio-Maxillofacial Surgery, Justus-Liebig University Giessen

Giessen, Hesse, 353 92, Germany

RECRUITING

Clinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Christian-Albrecht's University

Kiel, Schleswig-Holstein, 241 05, Germany

RECRUITING

Department of Maxillofacial Surgery, F. D. Roosevelt University Hospital

Banská Bystrica, Banská Bystrica Region, 975 17, Slovakia

RECRUITING

Related Publications (9)

  • Riad A, Klugar M, Krsek M. COVID-19-Related Oral Manifestations: Early Disease Features? Oral Dis. 2022 Apr;28 Suppl 1(Suppl 1):940-942. doi: 10.1111/odi.13516. Epub 2020 Jul 16. No abstract available.

    PMID: 32603497BACKGROUND

  • Riad A, Gad A, Hockova B, Klugar M. Oral candidiasis in non-severe COVID-19 patients: call for antibiotic stewardship. Oral Surg. 2022 Aug;15(3):465-466. doi: 10.1111/ors.12561. Epub 2020 Oct 9. No abstract available.

    PMID: 33042219BACKGROUND

  • Riad A, Kassem I, Stanek J, Badrah M, Klugarova J, Klugar M. Aphthous stomatitis in COVID-19 patients: Case-series and literature review. Dermatol Ther. 2021 Jan;34(1):e14735. doi: 10.1111/dth.14735. Epub 2021 Jan 10. No abstract available.

    PMID: 33389769BACKGROUND

  • Riad A, Kassem I, Hockova B, Badrah M, Klugar M. Halitosis in COVID-19 patients. Spec Care Dentist. 2021 Mar;41(2):282-285. doi: 10.1111/scd.12547. Epub 2020 Nov 29. No abstract available.

    PMID: 33249615BACKGROUND

  • Riad A, Kassem I, Badrah M, Klugar M. The manifestation of oral mucositis in COVID-19 patients: A case-series. Dermatol Ther. 2020 Nov;33(6):e14479. doi: 10.1111/dth.14479. Epub 2020 Nov 8. No abstract available.

    PMID: 33125803BACKGROUND

  • Riad A, Kassem I, Issa J, Badrah M, Klugar M. Angular cheilitis of COVID-19 patients: A case-series and literature review. Oral Dis. 2022 Apr;28 Suppl 1(Suppl 1):999-1000. doi: 10.1111/odi.13675. Epub 2020 Oct 23. No abstract available.

    PMID: 33043573BACKGROUND

  • Riad A, Kassem I, Hockova B, Badrah M, Klugar M. Tongue ulcers associated with SARS-CoV-2 infection: A case series. Oral Dis. 2022 Apr;28 Suppl 1:988-990. doi: 10.1111/odi.13635. Epub 2020 Sep 25. No abstract available.

    PMID: 32889763BACKGROUND

  • Riad A, Kassem I, Badrah M, Klugar M. Acute parotitis as a presentation of COVID-19? Oral Dis. 2022 Apr;28 Suppl 1:968-969. doi: 10.1111/odi.13571. Epub 2020 Aug 6. No abstract available.

    PMID: 32713097BACKGROUND

  • Riad A, Kassem I, Badrah M, Klugar M. COVID-19 transient snoring (CVTS): Clinical and laboratory description. J Med Virol. 2021 Apr;93(4):1890-1892. doi: 10.1002/jmv.26705. Epub 2020 Dec 17. No abstract available.

    PMID: 33289127BACKGROUND

Related Links

MeSH Terms

Conditions

Oral ManifestationsCOVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Abanoub Riad, DDS

    Masaryk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abanoub Riad, DDS

CONTACT

+420721046024abanoub.riad@med.muni.cz

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 12, 2021

Study Start

January 27, 2021

Primary Completion

February 28, 2021

Study Completion

March 31, 2021

Last Updated

February 25, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

In accordance with the General Data Protection Regulation (GDPR), the data controller is Masaryk University (MUNI) and will be used solely by MUNI for the purpose of research in area of public health. The collected data will not be accessed or used by other institutions or for any other purposes. The data will be processed and analysed during the duration of the project (approximately one year). After the project is finished, the data will be encrypted and safely stored by MU as a measure to secure the integrity of the research.

Locations

DE(2)SL(1)CZ(1)