Oral Manifestation in Patients With SARS-CoV2 Infection.

Sponsor

Fayoum University (Other)

Overall Status

Completed

CT.gov ID

NCT04821986

Collaborator

(none)

583

Enrollment

Location

6.5

Actual Duration (Months)

90.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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 .

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV Infection

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

583 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Oral Manifestation in Patients With SARS-CoV2 Infection.

Actual Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Oct 15, 2021

Outcome Measures

Primary Outcome Measures

oral manifestation [one week]
describe the patient oral manifestation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry	Fayoum		Egypt	63514

Sponsors and Collaborators

Fayoum University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alshaimaa Ahmed shabaan, associate professor in oral & maxillofacial Surgery Department, Fayoum University

ClinicalTrials.gov Identifier:

NCT04821986

Other Study ID Numbers:

Oral SARS-CoV2

First Posted:

Mar 30, 2021

Last Update Posted:

Nov 5, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alshaimaa Ahmed shabaan, associate professor in oral & maxillofacial Surgery Department, Fayoum University

oral Manifestation

SARS-CoV2

prevelance

Additional relevant MeSH terms:

Infections

Communicable Diseases

COVID-19

Severe Acute Respiratory Syndrome

Oral Manifestations

Study Results

No Results Posted as of Nov 5, 2021