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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04821986
Other study ID # Oral SARS-CoV2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date October 15, 2021

Study information

Verified date November 2021
Source Fayoum University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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 .


Description:

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 . Although 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.


Recruitment information / eligibility

Status Completed
Enrollment 583
Est. completion date October 15, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - A diagnosis of SARS-CoV2 with PCR. - Age range from 18-60 years old Exclusion Criteria: - Pregnancy or contraceptive pills - Lactation - Any auto-immune disease that could affect the oral mucosa - On any neoplastic therapy. - Uncontrolled diabetes

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Faculty of Dentistry Fayoum

Sponsors (1)

Lead Sponsor Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Halboub E, Al-Maweri SA, Alanazi RH, Qaid NM, Abdulrab S. Orofacial manifestations of COVID-19: a brief review of the published literature. Braz Oral Res. 2020 Oct 30;34:e124. doi: 10.1590/1807-3107bor-2020.vol34.0124. eCollection 2020. Review. — View Citation

La Rosa GRM, Libra M, De Pasquale R, Ferlito S, Pedullà E. Association of Viral Infections With Oral Cavity Lesions: Role of SARS-CoV-2 Infection. Front Med (Lausanne). 2021 Jan 14;7:571214. doi: 10.3389/fmed.2020.571214. eCollection 2020. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary oral manifestation describe the patient oral manifestation one week
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