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.
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
1,540
Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine
Department of Public Health, Faculty of Medicine, Masaryk University
Brno, South-Moravia, Czechia
RECRUITINGDepartment of Cranio-Maxillofacial Surgery, Justus-Liebig University Giessen
Giessen, Hesse, Germany
RECRUITINGClinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Christian-Albrecht's University
Kiel, Schleswig-Holstein, Germany
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.
Time frame: 0-30 days after the COVID-19 vaccine shot
Dermatologic Side Effects
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.
Time frame: 0-30 days after the COVID-19 vaccine shot
General (common) Side Effects
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.
Time frame: 0-30 days after the COVID-19 vaccine shot
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Department of Maxillofacial Surgery, F. D. Roosevelt University Hospital
Banská Bystrica, Banská Bystrica Region, Slovakia
RECRUITING