Oral Side Effects of COVID-19 Vaccine

Overview

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.

Full Title of Study: “Oral Side Effects of COVID-19 Vaccine: A Multicenter Cross-sectional Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: February 28, 2021

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)

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Masaryk University
  • Collaborator
    • F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Abanoub Riad, DDS, Principal Investigator, Masaryk University
  • Overall Contact(s)
    • Abanoub Riad, DDS, +420721046024, abanoub.riad@med.muni.cz

References

Riad A, Klugar M, Krsek M. COVID-19-Related Oral Manifestations: Early Disease Features? Oral Dis. 2020 Jun 30. doi: 10.1111/odi.13516. [Epub ahead of print]

Riad A, Gad A, Hockova B, Klugar M. Oral Candidiasis in Non-Severe COVID-19 Patients: Call for Antibiotic Stewardship. Oral Surg. 2020 Sep 21. doi: 10.1111/ors.12561. [Epub ahead of print]

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.

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.

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.

Riad A, Kassem I, Issa J, Badrah M, Klugar M. Angular cheilitis of COVID-19 patients: A case-series and literature review. Oral Dis. 2020 Oct 11. doi: 10.1111/odi.13675. [Epub ahead of print]

Riad A, Kassem I, Hockova B, Badrah M, Klugar M. Tongue ulcers associated with SARS-CoV-2 infection: A case series. Oral Dis. 2020 Sep 5. doi: 10.1111/odi.13635. [Epub ahead of print]

Riad A, Kassem I, Badrah M, Klugar M. Acute parotitis as a presentation of COVID-19? Oral Dis. 2020 Jul 25. doi: 10.1111/odi.13571. [Epub ahead of print]

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.

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