Oral Side Effects of COVID-19 Vaccine

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04706156
• Other study ID #: OSECV
• Status: Recruiting
• Start date: January 27, 2021
• Est. completion date: March 31, 2021

Study information

• Verified date: January 2021
• Source: Masaryk University
• Contact: Abanoub Riad, DDS
• Phone: +420721046024
• Email: abanoub.riad[@]med.muni.cz
• Is FDA regulated: No
• Study type: Observational

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1540
• Est. completion date: March 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Oral Manifestations
• Vaccine Adverse Reaction

Intervention

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

Locations

Country	Name	City	State
Czechia	Department of Public Health, Faculty of Medicine, Masaryk University	Brno	South-Moravia
Germany	Department of Cranio-Maxillofacial Surgery, Justus-Liebig University Giessen	Giessen	Hesse
Germany	Clinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Christian-Albrecht's University	Kiel	Schleswig-Holstein
Slovakia	Department of Maxillofacial Surgery, F. D. Roosevelt University Hospital	Banská Bystrica	Banska Bystrica

Sponsors (5)

Lead Sponsor	Collaborator
Masaryk University	F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica, University of Giessen, University of Kiel, Yeditepe University

Countries where clinical trial is conducted

Czechia,  Germany,  Slovakia, 

References & Publications (9)

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] — View Citation

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] — View Citation

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. — View Citation

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. — View Citation

Riad A, Kassem I, Hockova B, Badrah M, Klugar M. Halitosis in COVID-19 patients. Spec Care Dentist. 2020 Nov 29. doi: 10.1111/scd.12547. [Epub ahead of print] — View Citation

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] — View Citation

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] — View Citation

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. — View Citation

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] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-30 days after the COVID-19 vaccine shot
Secondary	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.	0-30 days after the COVID-19 vaccine shot
Secondary	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.	0-30 days after the COVID-19 vaccine shot

External Links

•   Annex 1
•   Effects of the Influenza Vaccine on the Oral Cavity