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Trial record 1 of 1 for:    NCT04706156
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Oral Side Effects of COVID-19 Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04706156
Recruitment Status : Unknown
Verified January 2021 by Masaryk University.
Recruitment status was:  Recruiting
First Posted : January 12, 2021
Last Update Posted : February 25, 2021
Sponsor:
Collaborators:
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
University of Giessen
University of Kiel
Yeditepe University
Information provided by (Responsible Party):
Masaryk University

Study Description
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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.

Condition or disease Intervention/treatment
Oral Manifestations Covid19 Vaccine Adverse Reaction Biological: COVID-19 Vaccine

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)

Study Design
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Study Type : Observational
Estimated Enrollment : 1540 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Oral Side Effects of COVID-19 Vaccine: A Multicenter Cross-sectional Study
Actual Study Start Date : January 27, 2021
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Vaccinated Healthcare Workers (CZ)
Czech healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)
 Biological: COVID-19 Vaccine
Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine
Vaccinated Healthcare Workers (DE)
German healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)
 Biological: COVID-19 Vaccine
Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine
Vaccinated Healthcare Workers (SK)
Slovak healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)
 Biological: COVID-19 Vaccine
Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine
Vaccinated Healthcare Workers (TR)
Turkish healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)
 Biological: COVID-19 Vaccine
Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706156


Contacts
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Contact: Abanoub Riad, DDS +420721046024 abanoub.riad@med.muni.cz

Locations
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Czechia
Department of Public Health, Faculty of Medicine, Masaryk University Recruiting
Brno, South-Moravia, Czechia, 625 00
Contact: Abanoub Riad, DDS    +420 549 49 6572    abanoub.riad@med.muni.cz   
Contact: Michal Koscik, PhD    +420 549 49 1324    koscik@med.muni.cz   
Germany
Department of Cranio-Maxillofacial Surgery, Justus-Liebig University Giessen Recruiting
Giessen, Hesse, Germany, 353 92
Contact: Sameh Attia, DDS       Sameh.Attia@dentist.med.uni-giessen.de   
Clinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Christian-Albrecht's University Recruiting
Kiel, Schleswig-Holstein, Germany, 241 05
Contact: Jonas Conrad, DDS       conrad@konspar.uni-kiel.de   
Contact: Mohamed Mekhemar, DDS       mekhemar@konspar.uni-kiel.de   
Slovakia
Department of Maxillofacial Surgery, F. D. Roosevelt University Hospital Recruiting
Banská Bystrica, Banska Bystrica, Slovakia, 975 17
Contact: Barbora Hocková, DDS       bhockova@nspbb.sk   
Sponsors and Collaborators
Masaryk University
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
University of Giessen
University of Kiel
Yeditepe University
Investigators
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Principal Investigator: Abanoub Riad, DDS Masaryk University
More Information
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Additional Information:

Publications:

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Responsible Party: Masaryk University
ClinicalTrials.gov Identifier: NCT04706156    
Other Study ID Numbers: OSECV
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: In accordance with the General Data Protection Regulation (GDPR), the data controller is Masaryk University (MUNI) and will be used solely by MUNI for the purpose of research in area of public health. The collected data will not be accessed or used by other institutions or for any other purposes. The data will be processed and analysed during the duration of the project (approximately one year). After the project is finished, the data will be encrypted and safely stored by MU as a measure to secure the integrity of the research.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Masaryk University:
COVID19
Oral Manifestations
Vaccine Adverse Reaction
Additional relevant MeSH terms:
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COVID-19
Oral Manifestations
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Mouth Diseases
Stomatognathic Diseases