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| Name | Class |
|---|---|
| Dokuz Eylul University | OTHER |
| Izmir Katip Celebi University | OTHER |
| Gazi University | OTHER |
| Istanbul Saglik Bilimleri University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Covid-19 (+) Patients | Experimental | Oral Examination, Radiography, oral (salivary) swap sample collection will be performed. |
|
| Healthy Individuals | Active Comparator | Oral Examination, Radiography, oral (salivary) swap sample collection will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cem Peskersoy | Ege University Faculty of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gazi University | Ankara | 06500 | Turkey (Türkiye) | |||
| Ege University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35502340 | Background | 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. | |
| 27513246 | 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. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D000848 | Anodontia |
| D000086382 | COVID-19 |
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D014071 | Tooth Abnormalities |
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| OTHER |
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Care provider, investigator and outcome assessors are chosen from separate specialists (Intensive Care Unit, Dentistry, Infectious Disease Departments).
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) |
| Izmir |
| 35100 |
| Turkey (Türkiye) |
| Izmir Katip Celebi University | Izmir | 35400 | Turkey (Türkiye) |
| Dokuz Eylul University | Izmir | 35600 | Turkey (Türkiye) |
| 35310855 | 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. |
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |