Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 2:53 AM
Study NCT ID:
NCT04893694
Status:
COMPLETED
Last Update Posted:
2021-08-24
First Post:
2021-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Prevalence of Oral Manifestation in Patients With SARS-CoV2 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D009912', 'term': 'Oral Manifestations'}], 'ancestors': [{'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'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 385}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-21', 'studyFirstSubmitDate': '2021-05-15', 'studyFirstSubmitQcDate': '2021-05-15', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral Manifestation', 'timeFrame': 'one week', 'description': 'presence or absence of Oral Manifestation in SARS-CO2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV2', 'Oral Manifestation', 'prevalence'], 'conditions': ['SARS-CoV2 Infection']}, 'referencesModule': {'references': [{'pmid': '32094336', 'type': 'BACKGROUND', 'citation': 'Xu H, Zhong L, Deng J, Peng J, Dan H, Zeng X, Li T, Chen Q. High expression of ACE2 receptor of 2019-nCoV on the epithelial cells of oral mucosa. Int J Oral Sci. 2020 Feb 24;12(1):8. doi: 10.1038/s41368-020-0074-x.'}, {'pmid': '32304276', 'type': 'BACKGROUND', 'citation': 'Dziedzic A, Wojtyczka R. The impact of coronavirus infectious disease 19 (COVID-19) on oral health. Oral Dis. 2021 Apr;27 Suppl 3(Suppl 3):703-706. doi: 10.1111/odi.13359. Epub 2020 May 6.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': 'The SARS-Cov2 virus was identified in china at the end of 2019 and spread worldwide causing a global pandemic. Current research showed that SARS-Cov2 virus invades human cells via the receptor angiotensin-converting enzyme 2 (ACE2) through scRNA-seq data analyses. The study identified the organs that are at risk and are vulnerable to SARS-CoV-2 infection. Therefore, cells with ACE2 receptor distribution may become host cells for the virus and cause inflammatory response in related organs and tissues, such as the tongue mucosa and salivary glands. These results suggest that oral mucosa could be a target of SARS-CoV-2 infection', 'detailedDescription': 'The oral cavity is particularly susceptible to viral infection with several viruses such as herpes simplex virus, cytomegalovirus and Zika virus because of its structures, especially salivary glands and soft tissues . Moreover, oral mucosa can be affected by secondary pathological process of a bacterial or fungal nature due to viral immunosuppression. The oral cavity could be considered a "biological barometer" of both viral infection and viral immunosuppression advancement .\n\nThe SARS-Cov2 virus was identified in china at the end of 2019 and spread worldwide causing a global pandemic. Current research showed that SARS-Cov2 virus invades human cells via the receptor angiotensin-converting enzyme 2 (ACE2) through scRNA-seq data analyses. The study identified the organs that are at risk and are vulnerable to SARS-CoV-2 infection. Therefore, cells with ACE2 receptor distribution may become host cells for the virus and cause inflammatory response in related organs and tissues, such as the tongue mucosa and salivary glands. These results suggest that oral mucosa could be a target of SARS-CoV-2 infection .\n\nAlthough many authors reported the presence of oral lesion associated with SARS-CoV2 infection, the prevalence of the oral manifestation and the range of oral manifestation are still unknown. Further studies are necessary to better understanding of the symptoms of the SARS-CoV2 virus in order to faster detection. A multidisciplinary team following the patients could be the key in treatment of the infection and faster recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a multicenter cross- sectional study to study the prevalence of oral manifestation among patients with SARS-CoV2 infection and identify the range of the oral manifestation and site of lesions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of SARS-CoV2 with PCR.\n* Age range from 18-60 years old\n* Hospital admission not more than 10 days\n\nExclusion Criteria:\n\n* Pregnancy or contraceptive pills\n* Lactation\n* Any auto-immune disease that could affect the oral mucosa\n* On any neoplastic therapy.\n* Uncontrolled diabetes.'}, 'identificationModule': {'nctId': 'NCT04893694', 'briefTitle': 'the Prevalence of Oral Manifestation in Patients With SARS-CoV2 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': 'the Prevalence of Oral Manifestation in Patients With SARS-CoV2 Infection', 'orgStudyIdInfo': {'id': 'Oral SARS 2'}}, 'contactsLocationsModule': {'locations': [{'zip': '63514', 'city': 'Al Fayyum', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health and Population, Egypt', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor in oral & maxillofacial Surgery Department', 'investigatorFullName': 'Alshaimaa Ahmed shabaan', 'investigatorAffiliation': 'Fayoum University'}}}}