Clinical trial NCT04706156: Oral Side Effects of COVID-19 Vaccine
Official title: Oral Side Effects of COVID-19 Vaccine: A Multicenter Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Manifestations
Covid19
Vaccine Adverse Reaction
Keywords: COVID19
Oral Manifestations
Vaccine Adverse Reaction
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
name: University of Giessen
name: University of Kiel
name: Yeditepe University
First posted: 2021-01-12
Enrollment: 1540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Oral Side Effects
timeFrame: 0-30 days after the COVID-19 vaccine shot
Secondary outcomes:
measure: Dermatologic Side Effects
timeFrame: 0-30 days after the COVID-19 vaccine shot
measure: General (common) Side Effects
timeFrame: 0-30 days after the COVID-19 vaccine shot
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Department of Public Health, Faculty of Medicine, Masaryk University
state: South-Moravia
city: Giessen
country: Germany
facility: Department of Cranio-Maxillofacial Surgery, Justus-Liebig University Giessen
state: Hesse
city: Kiel
country: Germany
facility: Clinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Christian-Albrecht's University
state: Schleswig-Holstein
city: Banská Bystrica
country: Slovakia
facility: Department of Maxillofacial Surgery, F. D. Roosevelt University Hospital
state: Banska Bystrica
Study officials:
affiliation: Masaryk University
name: Abanoub Riad, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Riad A, Klugar M, Krsek M. COVID-19-Related Oral Manifestations: Early Disease Features? Oral Dis. 2022 Apr;28 Suppl 1(Suppl 1):940-942. doi: 10.1111/odi.13516. Epub 2020 Jul 16. No abstract available.
citation: Riad A, Gad A, Hockova B, Klugar M. Oral candidiasis in non-severe COVID-19 patients: call for antibiotic stewardship. Oral Surg. 2022 Aug;15(3):465-466. doi: 10.1111/ors.12561. Epub 2020 Oct 9. No abstract available.
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. No abstract available.
citation: 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. No abstract available.
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. No abstract available.
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. 2022 Apr;28 Suppl 1(Suppl 1):999-1000. doi: 10.1111/odi.13675. Epub 2020 Oct 23. No abstract available.
citation: Riad A, Kassem I, Hockova B, Badrah M, Klugar M. Tongue ulcers associated with SARS-CoV-2 infection: A case series. Oral Dis. 2022 Apr;28 Suppl 1:988-990. doi: 10.1111/odi.13635. Epub 2020 Sep 25. No abstract available.
citation: Riad A, Kassem I, Badrah M, Klugar M. Acute parotitis as a presentation of COVID-19? Oral Dis. 2022 Apr;28 Suppl 1:968-969. doi: 10.1111/odi.13571. Epub 2020 Aug 6. No abstract available.
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. No abstract available.