Oral Side Effects of COVID-19 Vaccine

Covid19 Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Covid19
• Oral Manifestations
• Vaccine Adverse Reaction

• NCT number: NCT04706156
• Study type: Observational
• Source: Masaryk University
• Contact: Abanoub Riad, DDS
• Phone: +420721046024
• Email: abanoub.riad@med.muni.cz
• Status: Recruiting
• Start date: January 27, 2021
• Completion date: March 31, 2021