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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Oral Health Status and Cytokine Levels in Sars-Cov-2 Hospitalized Patients: A Randomized Clinical Trial

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

Intervention / Treatment
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* Diagnostic Test: ELISA test for Cytokines


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Covid-19 (+) Patients<br>Oral Examination, Radiography, oral (salivary) swap sample collection will be performed. | Diagnostic Test: ELISA test for Cytokines<br>* 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.<br>|
| Active Comparator: Healthy Individuals<br>Oral Examination, Radiography, oral (salivary) swap sample collection will be performed. | Diagnostic Test: ELISA test for Cytokines<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) |