Oral Side Effects of COVID-19 Vaccine

February 23, 2021 updated by: Masaryk University

Oral Side Effects of COVID-19 Vaccine: A Multicenter Cross-sectional Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this multicentre cross-sectional survey-based study is to estimate the prevalence of oral side effects of COVID-19 vaccine in the short term.

The secondary objectives are:

  • to identify the risk factors of COVID-19 vaccine oral side effects in the short term.
  • to evaluate the relationship between oral side effects and other inflammatory side effects of COVID-19 vaccine in the short term.

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.

A self-administered questionnaire will be developed, and its content validity will be tested using a panel of experts. The test re-test reliability of the questionnaire will be tested by 30 volunteers (10 Czech, 10 Turkish, 10 German) to achieve at least a Cronbach's alpha of 0.70. The questionnaire will be available in five languages; Czech, English, German, Slovak and Turkish. Dual forward translation and expert panels will produce equivalent Czech, German, Slovak and Turkish versions of the questionnaire.

The questionnaire will be composed of multiple-choice items divided into four main categories; a) demographic data including gender, age, location of practice, profession, and experience, b) medical anamnesis including medical comorbidities, medications, and recent oral symptoms, c) COVID-19 related anamnesis including vaccination date, previous infection, and exposure to infected cases, and d) vaccine side effects including inflammatory symptoms, cutaneous symptoms, and oral symptoms. (Annex 1)

Study Type

Observational

Enrollment (Anticipated)

1540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • South-Moravia
      • Brno, South-Moravia, Czechia, 625 00
        • Recruiting
        • Department of Public Health, Faculty of Medicine, Masaryk University
        • Contact:
        • Contact:
  • Germany
    • Hesse
      • Giessen, Hesse, Germany, 353 92
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 241 05
  • Slovakia
    • Banska Bystrica
      • Banská Bystrica, Banska Bystrica, Slovakia, 975 17
        • Recruiting
        • Department of Maxillofacial Surgery, F. D. Roosevelt University Hospital
        • Contact:

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

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaccinated Healthcare Workers (CZ)
Czech healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)
Biological: COVID-19 Vaccine
Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac 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
Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac 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
Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac 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
Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Side Effects
Time Frame: 0-30 days after the COVID-19 vaccine shot
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermatologic Side Effects
Time Frame: 0-30 days after the COVID-19 vaccine shot
Dichotomous outcome for the emergence of dermatologic side effects (e.g. injection site swelling, or redness, rash, urticaria, angioedema, etc) following receiving the COVID-19 vaccine.
0-30 days after the COVID-19 vaccine shot
General (common) Side Effects
Time Frame: 0-30 days after the COVID-19 vaccine shot
Dichotomous outcome for the emergence of typical side effects (e.g. injection site pain, injection site swelling, injection site redness, tiredness, headache, nausea, muscle pain, joint pain, fever, swollen lymph nodes (lymphadenopathy), etc) following receiving the COVID-19 vaccine.
0-30 days after the COVID-19 vaccine shot

Collaborators and Investigators

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

Sponsor

Masaryk University

Collaborators

University of Kiel
University of Giessen
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Yeditepe University

Investigators

  • Principal Investigator: Abanoub Riad, DDS, Masaryk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

January 27, 2021

Primary Completion (Anticipated)

February 28, 2021

Study Completion (Anticipated)

March 31, 2021

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSECV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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