Relationship Between Oral Findings and Salivary Factors in Sars-Cov-2 Patients

NCT05476848 | Completed DMC

• 1 other identifier: 21-6.1T/70
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 4

Brief Summary

Two hundred individuals will be formed according to the study and control groups: Group-1: coronavirus 2 (Covid-19) (+) patients (n=100) and Group-2: Healthy individuals (in which the volunteers will be included due to group-1) (n=100). Oral examinations including DMFT scores, salivary flow rate, visible gingival index scores and radiographs (OPG) will be performed on both groups on the 1st appointment. Oral swap samples will be collected with sterile swap brushes (Six sample for each person) on the 1st, 7th and 30th days to evaluate the salivary immunoglobulins (Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM)) and cytokine (IL-1, IL-6, IL-10) levels. Blood samples will be collected to validate the oral swap test results.

Conditions

Decay, Dental; Missing Teeth; COVID-19; Cytokine Storm

Outcome Measures

Primary Outcomes (6)

• DMF Index

  Decay, Missing, Filled teeth scores will be recorded and evaluated for both study groups.

  Baseline (1st appointment)

• Dental Plaque Status - GI

  Gingival Index scores (visible dental plaque) will be evaluated for both study groups.

  Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)

• Periodontal Bleeding Status - BoP

  Bleeding volume (ml/sec) on probing will be evaluated for both study groups.

  Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)

• Salivary Flow Rate

  Salivary flow rate of each participant is calculated by measuring the unstimulated saliva volume (ml/min).

  Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)

• Oral Cytokine Levels

  Oral cytokine levels will be evaluated for both study groups three times, due to the half-life of specific markers (IL-1, IL-6, IL-10).

  Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)

• Oral Immunoglobulin Levels

  and immunoglobulin levels will be evaluated for both study groups three times, due to the half-life of specific markers (IgA, IgG, IgM).

  Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)

Secondary Outcomes (3)

• Age Range of the Participants

  Baseline (1st appointment)

• Gender Distribution

  Baseline (1st appointment)

• Systemical Diseases

  Baseline (1st appointment)

Study Arms (2)

Covid-19 (+) Patients

EXPERIMENTAL

Oral Examination, Radiography, oral (salivary) swap sample collection will be performed.

Diagnostic Test: ELISA test for Cytokines

Healthy Individuals

ACTIVE COMPARATOR

Oral Examination, Radiography, oral (salivary) swap sample collection will be performed.

Diagnostic Test: ELISA test for Cytokines

Interventions

ELISA test for Cytokines DIAGNOSTIC_TEST

ELISA tests specific for cytokines (IL-1, IL-6, IL-10) and immunoglobulins (IgA, IgG, IgM) will be performed by a biochemistry lab, both for blood samples and oral swap samples.

Covid-19 (+) Patients; Healthy Individuals

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Covid (+) patients,
• Patients who were hospitalized due to Acute Respiratory Deficiency,
• Conscious patients in ICU (intensive care unit) or IDMC (Infectious Diseases and Microbiology Clinic).

You may not qualify if:

• Patients with Cancer,
• Patients with Autoimmune System diseases,
• Pregnant women,
• Patients with Immune Deficiency diseases (Acquired immune deficiency syndrome - AIDS, Autoimmune lymphoproliferative syndrome - ALPS , Chronic granulomatous disease - CGD, etc.).

Sponsors & Collaborators

• Ege University: lead
• Dokuz Eylul University: collaborator
• Izmir Katip Celebi University: collaborator
• Gazi University: collaborator
• Istanbul Saglik Bilimleri University: collaborator

Study Sites (4)

Gazi University

Ankara, 06500, Turkey (Türkiye)

Location

Ege University

Izmir, 35100, Turkey (Türkiye)

Location

Izmir Katip Celebi University

Izmir, 35400, Turkey (Türkiye)

Location

Dokuz Eylul University

Izmir, 35600, Turkey (Türkiye)

Location

Related Publications (3)

• Peskersoy C, Oguzhan A, Gurlek O. The Effect of Flowable Composite Resins on Periodontal Health, Cytokine Levels, and Immunoglobulins. Biomed Res Int. 2022 Apr 23;2022:6476597. doi: 10.1155/2022/6476597. eCollection 2022.

  PMID: 35502340 BACKGROUND

• Peskersoy C, Peker S, Kaya A, Unalp A, Gokay N. Evaluation of the relationship between migraine disorder andoral comorbidities: multicenter randomized clinical trial. Turk J Med Sci. 2016 Apr 19;46(3):712-8. doi: 10.3906/sag-1412-71.

  PMID: 27513246 BACKGROUND

• Alfaifi A, Sultan AS, Montelongo-Jauregui D, Meiller TF, Jabra-Rizk MA. Long-Term Post-COVID-19 Associated Oral Inflammatory Sequelae. Front Cell Infect Microbiol. 2022 Mar 2;12:831744. doi: 10.3389/fcimb.2022.831744. eCollection 2022.

  PMID: 35310855 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Anodontia; COVID-19; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Cem Peskersoy

  Ege University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Care provider, investigator and outcome assessors are chosen from separate specialists (Intensive Care Unit, Dentistry, Infectious Disease Departments).
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: July 27, 2022
• Study Start: March 1, 2022
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4)