Oral Side Effects of COVID-19 Vaccine

• Conditions: Vaccine Adverse Reaction; Oral Manifestations; Covid19
• Interventions: Biological: COVID-19 Vaccine

• Registration Number: NCT04706156
• Lead Sponsor: Masaryk University

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.

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 Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-12
• Study Start: 2021-01-27
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-25
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1540

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaccinated Healthcare Workers (TR)	COVID-19 Vaccine	Turkish healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)
Vaccinated Healthcare Workers (CZ)	COVID-19 Vaccine	Czech healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)
Vaccinated Healthcare Workers (SK)	COVID-19 Vaccine	Slovak healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)
Vaccinated Healthcare Workers (DE)	COVID-19 Vaccine	German healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)

Primary Outcome Measures

Name	Time	Method
Oral Side Effects	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.

Secondary Outcome Measures

Name	Time	Method
General (common) Side Effects	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.
Dermatologic Side Effects	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.

Trial Locations

Locations (4)

Clinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Christian-Albrecht's University; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Department of Cranio-Maxillofacial Surgery, Justus-Liebig University Giessen; 🇩🇪 Giessen, Hesse, Germany

Department of Maxillofacial Surgery, F. D. Roosevelt University Hospital; 🇸🇰 Banská Bystrica, Banska Bystrica, Slovakia

Department of Public Health, Faculty of Medicine, Masaryk University; 🇨🇿 Brno, South-Moravia, Czechia