Oral ManifestationsNCT04706156
Oral Side Effects of COVID-19 Vaccine
An observational study of Oral Manifestations and Covid19, run by Masaryk University at 4 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Manifestations, Covid19, Vaccine Adverse Reaction
- What is being tested?
- COVID-19 Vaccine
- Type of treatment
- Vaccines
- How many people
- 1,540 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 27 Jan 2021to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- The healthcare workers who did not receive the COVID-19 vaccine recently.
- Non-healthcare workers who received the COVID-19 vaccine recently.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites, 2 recruiting
- Recruiting
Department of Cranio-Maxillofacial Surgery, Justus-Liebig University Giessen
Giessen, Hesse, 353 92
Sameh Attia, DDS, Sameh.Attia@dentist.med.uni-giessen.de
- Recruiting
Clinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Christian-Albrecht's University
Kiel, Schleswig-Holstein, 241 05
Jonas Conrad, DDS, conrad@konspar.uni-kiel.de
Mohamed Mekhemar, DDS, mekhemar@konspar.uni-kiel.de
Czechia1 site, 1 recruiting
- Recruiting
Department of Public Health, Faculty of Medicine, Masaryk University
Brno, South-Moravia, 625 00
Abanoub Riad, DDS, +420 549 49 6572, abanoub.riad@med.muni.cz
Michal Koscik, PhD, +420 549 49 1324, koscik@med.muni.cz
Slovakia1 site, 1 recruiting
- Recruiting
Department of Maxillofacial Surgery, F. D. Roosevelt University Hospital
Banská Bystrica, Banská Bystrica Region, 975 17
Barbora Hocková, DDS, bhockova@nspbb.sk
About this study
Official title: Oral Side Effects of COVID-19 Vaccine: A Multicenter Cross-sectional Study
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.
Read the 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)
- Conditions
- Oral Manifestations, Covid19, Vaccine Adverse Reaction
- Being tested
- COVID-19 Vaccine
- Keywords
- COVID19, Oral Manifestations, Vaccine Adverse Reaction
- Medical subject headings
- Oral Manifestations, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccineBiological
Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated Healthcare Workers (CZ) | Czech healthcare workers who received COVID-19 vaccine during the last 30 days (n=385) Receives: Biological: COVID-19 Vaccine | |
| Vaccinated Healthcare Workers (DE) | German healthcare workers who received COVID-19 vaccine during the last 30 days (n=385) Receives: Biological: COVID-19 Vaccine | |
| Vaccinated Healthcare Workers (SK) | Slovak healthcare workers who received COVID-19 vaccine during the last 30 days (n=385) Receives: Biological: COVID-19 Vaccine | |
| Vaccinated Healthcare Workers (TR) | Turkish healthcare workers who received COVID-19 vaccine during the last 30 days (n=385) Receives: Biological: COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-30 days after the COVID-19 vaccine shot
Secondary outcomes (2)
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.
Measured: 0-30 days after the COVID-19 vaccine shot
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.
Measured: 0-30 days after the COVID-19 vaccine shot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start27 Jan 2021
- Primary completion28 Feb 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Oral ManifestationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica, University of Giessen, University of Kiel, Yeditepe University
- Responsible party
- Sponsor
- Investigators
- Abanoub Riad, DDS, Principal investigator, Masaryk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706156
- Sponsor's protocol ID
- OSECV
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32603497Riad 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.
PubMed 33042219Riad 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.
PubMed 33389769Riad 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.
PubMed 33249615Riad 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.
PubMed 33125803Riad 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.
PubMed 33043573Riad 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.
PubMed 32889763Riad 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.
PubMed 32713097Riad 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.
PubMed 33289127
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Side Effects of COVID-19 Vaccine: A Multicenter Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04706156
- Acronym / sponsor ID
- OSECV
- Conditions
- Oral Manifestations, Covid19, Vaccine Adverse Reaction
- Keywords
- COVID19, Oral Manifestations, Vaccine Adverse Reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,540 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica, University of Giessen, University of Kiel, Yeditepe University
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vaccinated Healthcare Workers (CZ) | – | Biological: COVID-19 VaccineCzech healthcare workers who received COVID-19 vaccine during the last 30 days (n=385) |
| Vaccinated Healthcare Workers (DE) | – | Biological: COVID-19 VaccineGerman healthcare workers who received COVID-19 vaccine during the last 30 days (n=385) |
| Vaccinated Healthcare Workers (SK) | – | Biological: COVID-19 VaccineSlovak healthcare workers who received COVID-19 vaccine during the last 30 days (n=385) |
| Vaccinated Healthcare Workers (TR) | – | Biological: COVID-19 VaccineTurkish healthcare workers who received COVID-19 vaccine during the last 30 days (n=385) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- The healthcare workers who did not receive the COVID-19 vaccine recently.
- Non-healthcare workers who received the COVID-19 vaccine recently.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 VaccineReceiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine | Biological | Vaccinated Healthcare Workers (CZ), Vaccinated Healthcare Workers (DE), Vaccinated Healthcare Workers (SK), Vaccinated Healthcare Workers (TR) |
Primary outcome
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.
2 secondary outcomes
Dermatologic Side Effects
Time frame: 0-30 days after the COVID-19 vaccine shot
General (common) Side Effects
Time frame: 0-30 days after the COVID-19 vaccine shot
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Background: PubMed 32603497Riad 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.
- Background: PubMed 33042219Riad 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.
- Background: PubMed 33389769Riad 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.
- Background: PubMed 33249615Riad 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.
- Background: PubMed 33125803Riad 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.
- Background: PubMed 33043573Riad 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.
- Background: PubMed 32889763Riad 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.
- Background: PubMed 32713097Riad 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.
- Background: PubMed 33289127Riad 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.
- Effects of the Influenza Vaccine on the Oral CavityLink provided by the sponsor.
- Annex 1Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abanoub Riad, DDS principal investigator
Masaryk University
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Manifestations and Covid19, run by Masaryk University at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Czechia, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abanoub Riad, DDS (+420721046024, abanoub.riad@med.muni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Side Effects (time frame: 0-30 days after the COVID-19 vaccine shot). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04706156, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.