NCT04893694

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

May 15, 2021

Last Update Submit

August 21, 2021

Conditions

Keywords

SARS-CoV2Oral Manifestationprevalence

Outcome Measures

Primary Outcomes (1)

  • Oral Manifestation

    presence or absence of Oral Manifestation in SARS-CO2

    one week

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • A diagnosis of SARS-CoV2 with PCR.
  • Age range from 18-60 years old
  • Hospital admission not more than 10 days

You may not qualify if:

  • Pregnancy or contraceptive pills
  • Lactation
  • Any auto-immune disease that could affect the oral mucosa
  • On any neoplastic therapy.
  • Uncontrolled diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Al Fayyum, 63514, Egypt

Location

Related Publications (3)

  • 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: 32094336BACKGROUND
  • 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: 32304276BACKGROUND
  • 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: 32603497BACKGROUND

MeSH Terms

Conditions

COVID-19Oral Manifestations

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMouth DiseasesStomatognathic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor in oral & maxillofacial Surgery Department

Study Record Dates

First Submitted

May 15, 2021

First Posted

May 19, 2021

Study Start

May 20, 2021

Primary Completion

June 20, 2021

Study Completion

July 15, 2021

Last Updated

August 24, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations