NCT04821986

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 .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
583

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 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

March 29, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

November 5, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

March 29, 2021

Last Update Submit

November 4, 2021

Conditions

Keywords

oral ManifestationSARS-CoV2prevelance

Outcome Measures

Primary Outcomes (1)

  • oral manifestation

    describe the patient oral manifestation

    one week

Eligibility Criteria

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

Patients with SARS-CoV2 infection confirmed with PCR will be recruited form 3 different isolation hospitals at Ministry of health and population. Patient selection will be based on certain inclusion and exclusion criteria.

You may qualify if:

  • A diagnosis of SARS-CoV2 with PCR.
  • Age range from 18-60 years old

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 (2)

  • La Rosa GRM, Libra M, De Pasquale R, Ferlito S, Pedulla 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.

  • 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.

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeOral Manifestations

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus 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

March 29, 2021

First Posted

March 30, 2021

Study Start

April 1, 2021

Primary Completion

September 30, 2021

Study Completion

October 15, 2021

Last Updated

November 5, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations