Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-26 @ 4:49 PM
Study NCT ID:
NCT04706156
Status:
UNKNOWN
Last Update Posted:
2021-02-25
First Post:
2021-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Side Effects of COVID-19 Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009912', 'term': 'Oral Manifestations'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086663', 'term': 'COVID-19 Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1540}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2021-01-11', 'studyFirstSubmitQcDate': '2021-01-11', 'lastUpdatePostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral Side Effects', 'timeFrame': '0-30 days after the COVID-19 vaccine shot', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Dermatologic Side Effects', 'timeFrame': '0-30 days after the COVID-19 vaccine shot', 'description': '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.'}, {'measure': 'General (common) Side Effects', 'timeFrame': '0-30 days after the COVID-19 vaccine shot', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID19', 'Oral Manifestations', 'Vaccine Adverse Reaction'], 'conditions': ['Oral Manifestations', 'Covid19', 'Vaccine Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '32603497', 'type': 'BACKGROUND', '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.'}, {'pmid': '33042219', 'type': 'BACKGROUND', '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.'}, {'pmid': '33389769', 'type': 'BACKGROUND', '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.'}, {'pmid': '33249615', 'type': 'BACKGROUND', '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.'}, {'pmid': '33125803', 'type': 'BACKGROUND', '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.'}, {'pmid': '33043573', 'type': 'BACKGROUND', '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.'}, {'pmid': '32889763', 'type': 'BACKGROUND', '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.'}, {'pmid': '32713097', 'type': 'BACKGROUND', '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.'}, {'pmid': '33289127', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'https://stars.library.ucf.edu/cgi/viewcontent.cgi?article=1306&context=honorstheses', 'label': 'Effects of the Influenza Vaccine on the Oral Cavity'}, {'url': 'https://muni.cz/go/osecv', 'label': 'Annex 1'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe secondary objectives are:\n\n* to identify the risk factors of COVID-19 vaccine oral side effects in the short term.\n* to evaluate the relationship between oral side effects and other inflammatory side effects of COVID-19 vaccine in the short term.\n\nThe 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.\n\nA 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.\n\nThe 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)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthcare workers who received COVID-19 vaccine during the last 30 days.\n* Participating subjects should be at least 18-year-old and able to give their informed consent independently.\n\nExclusion Criteria:\n\n* The healthcare workers who did not receive the COVID-19 vaccine recently.\n* Non-healthcare workers who received the COVID-19 vaccine recently.'}, 'identificationModule': {'nctId': 'NCT04706156', 'briefTitle': 'Oral Side Effects of COVID-19 Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'Masaryk University'}, 'officialTitle': 'Oral Side Effects of COVID-19 Vaccine: A Multicenter Cross-sectional Study', 'orgStudyIdInfo': {'id': 'OSECV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaccinated Healthcare Workers (CZ)', 'description': 'Czech healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)', 'interventionNames': ['Biological: COVID-19 Vaccine']}, {'label': 'Vaccinated Healthcare Workers (DE)', 'description': 'German healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)', 'interventionNames': ['Biological: COVID-19 Vaccine']}, {'label': 'Vaccinated Healthcare Workers (SK)', 'description': 'Slovak healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)', 'interventionNames': ['Biological: COVID-19 Vaccine']}, {'label': 'Vaccinated Healthcare Workers (TR)', 'description': 'Turkish healthcare workers who received COVID-19 vaccine during the last 30 days (n=385)', 'interventionNames': ['Biological: COVID-19 Vaccine']}], 'interventions': [{'name': 'COVID-19 Vaccine', 'type': 'BIOLOGICAL', 'description': 'Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine', 'armGroupLabels': ['Vaccinated Healthcare Workers (CZ)', 'Vaccinated Healthcare Workers (DE)', 'Vaccinated Healthcare Workers (SK)', 'Vaccinated Healthcare Workers (TR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '625 00', 'city': 'Brno', 'state': 'South-Moravia', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Abanoub Riad, DDS', 'role': 'CONTACT', 'email': 'abanoub.riad@med.muni.cz', 'phone': '+420 549 49 6572'}, {'name': 'Michal Koscik, PhD', 'role': 'CONTACT', 'email': 'koscik@med.muni.cz', 'phone': '+420 549 49 1324'}], 'facility': 'Department of Public Health, Faculty of Medicine, Masaryk University', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '353 92', 'city': 'Giessen', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sameh Attia, DDS', 'role': 'CONTACT', 'email': 'Sameh.Attia@dentist.med.uni-giessen.de'}], 'facility': 'Department of Cranio-Maxillofacial Surgery, Justus-Liebig University Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '241 05', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jonas Conrad, DDS', 'role': 'CONTACT', 'email': 'conrad@konspar.uni-kiel.de'}, {'name': 'Mohamed Mekhemar, DDS', 'role': 'CONTACT', 'email': 'mekhemar@konspar.uni-kiel.de'}], 'facility': "Clinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Christian-Albrecht's University", 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '975 17', 'city': 'Banská Bystrica', 'state': 'Banská Bystrica Region', 'status': 'RECRUITING', 'country': 'Slovakia', 'contacts': [{'name': 'Barbora Hocková, DDS', 'role': 'CONTACT', 'email': 'bhockova@nspbb.sk'}], 'facility': 'Department of Maxillofacial Surgery, F. D. Roosevelt University Hospital', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}], 'centralContacts': [{'name': 'Abanoub Riad, DDS', 'role': 'CONTACT', 'email': 'abanoub.riad@med.muni.cz', 'phone': '+420721046024'}], 'overallOfficials': [{'name': 'Abanoub Riad, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masaryk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masaryk University', 'class': 'OTHER'}, 'collaborators': [{'name': 'F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica', 'class': 'OTHER'}, {'name': 'University of Giessen', 'class': 'OTHER'}, {'name': 'University of Kiel', 'class': 'OTHER'}, {'name': 'Yeditepe University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}