Recurrent Salivary Gland Infections in Covid-19 (RecSalivary)

June 2, 2023 updated by: Eslam Farid Abu Shady ,MD, Benha University
The aim of this study is to find out the role of Covid-19 in salivary gland infection and its recurrence.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

This is a prospective clinical study of 60 patients. The study will be performed in the Otolaryngology department, Faculty of Medicine, Benha University during the duration from June 2023 to December 2023.

Inclusion criteria:

Adult patients aged ≥18 years.

Exclusion criteria:

  • Patients with known autoimmune diseases,
  • Diabetes Mellitus
  • History of cancer in the region of the head and neck or previous radio and/or chemotherapy.
  • History of facial nerve palsy,
  • Oral and dental diseases including chronic sialadenitis or sialolithiasis.
  • previous oral surgery.

Patients were divided into two equal groups each of 30 patients according to the cause of infection. Group (1) comprises 30 patients with Covid-19 infection representing the study group COVID-19 diagnosis will be based on a positive SARS-CoV-2 nasopharyngeal swab on real-time reverse transcription-polymerase chain reaction (RT-PCR) in the presence of clinical and/or radiological signs and group (2) comprises of 30 patients with non-Covid-19 infection as a control group.

All patients will be submitted to full ENT and intraoral clinical examination. We will Compare both groups as regards patients' characteristics, risk factors, etiology, symptoms, and rate of recurrence of sialadenitis.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banhā, Egypt
        • Benha University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adult patients aged ≥18 years with a history of CIVID-19 infection in the study group and of similar age without a history of COVID-19 infection.

Description

Inclusion Criteria:

  • Adult patients aged ≥18 years with a history of CIVID-19 infection in the study group and of similar age without a history of COVID-19 infection.

Exclusion Criteria:

  • Patients with known autoimmune diseases,
  • Diabetes Mellitus
  • History of cancer in the region of the head and neck or previous radio and/or chemotherapy.
  • History of facial nerve palsy,
  • Oral and dental diseases including chronic sialadenitis or sialolithiasis.
  • previous oral surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study group
comprises 30 patients with Covid-19 infection representing the study group COVID-19 diagnosis will be based on a positive SARS-CoV-2 nasopharyngeal swab on real-time reverse transcription-polymerase chain reaction (RT-PCR) in the presence of clinical and/or radiological signs.
Control group
comprises 30 patients without a history of Covid-19 infection as a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence or recurrence of sialoadenitis
Time Frame: 6 months
Compare both groups as regards patients' characteristics, risk factors, etiology, symptoms, and rate of recurrence of sialadenitis.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: Eslam Abu Shady, MD, medical school

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 21-4-2023
  • Benha University (Benha university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Salivary Gland Infections in Covid-19

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe