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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05476848
Other study ID # 21-6.1T/70
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date August 10, 2023

Study information

Verified date August 2023
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) is the virus responsible for coronavirus disease 2019 (COVID-19) which also affects all systems of the body including the oral environment. Recent studies have demonstrated the association between oral health status and systemic diseases. including systemic infections and respiratory diseases. Aim of this study is to analyze the immunoglobulin and cytokine levels of SARS-CoV-2 patients and correlate the oral health status of these patients. Our hypotheses are, 1) Covid-19 affects individuals with low oral hygiene (high DMFT score) more severely, 2) Oral cytokine levels will increase similarly to blood levels in patients with Covid-19, 3) Oral immunoglobulin levels in patients with Covid-19 decreased similarly to those in blood. Oral examination of 100 Covid (+) patients which were hospitalized due to acute respiratory failure will be performed in the dental department of each faculty hospital. Decay-Missing-Filled Tooth (DMFT) scores, visible gingival plaque index (Löe-Silness), Bleeding on Probing (BoP) scores, and orthopantomographs (OPG) will be collected for each participant. Oral swap specimens will be collected (6 sample for each person) to evaluate the levels of salivary immunoglobulins (IgA, IgG, IgM) and cytokines (IL-1, IL-6, IL-10) on 1st, 7th, and 30th days. ELISA test will be performed for immunological analysis with ready-made kits (SunRed Biotech. Co, Shanghai, China). Full blood analyses will be performed to validate and correlate the actual cytokine and immunoglobulin levels.


Recruitment information / eligibility

Status Completed
Enrollment 320
Est. completion date August 10, 2023
Est. primary completion date August 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - 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.).

Study Design


Intervention

Diagnostic Test:
ELISA test for Cytokines
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.

Locations

Country Name City State
Turkey Gazi University Ankara
Turkey Dokuz Eylul University Izmir
Turkey Ege University Izmir
Turkey Izmir Katip Celebi University Izmir

Sponsors (5)

Lead Sponsor Collaborator
Ege University Dokuz Eylul University, Gazi University, Istanbul Saglik Bilimleri University, Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary DMF Index Decay, Missing, Filled teeth scores will be recorded and evaluated for both study groups. Baseline (1st appointment)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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 Age Range of the Participants The age distributions of the participants in the study will be recorded, so that it will be examined which age group is affected the most from Covid-19 disease (min age: 18, max age 80). Baseline (1st appointment)
Secondary Gender Distribution The gender distributions of the participants in the study will be recorded, so that it will be examined which gender group is affected the most from Covid-19 disease. Baseline (1st appointment)
Secondary Systemical Diseases The systemic diseases of the participants in the study will be recorded so that it will be examined with which systemic disease the Covid-19 disease can be most associated. Baseline (1st appointment)
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