COVID-19 Clinical Trial
Official title:
Evaluation of Oral Health Status and Cytokine Levels in Sars-Cov-2 Hospitalized Patients: A Randomized Clinical Trial
Verified date | August 2023 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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.). |
Country | Name | City | State |
---|---|---|---|
Turkey | Gazi University | Ankara | |
Turkey | Dokuz Eylul University | Izmir | |
Turkey | Ege University | Izmir | |
Turkey | Izmir Katip Celebi University | Izmir |
Lead Sponsor | Collaborator |
---|---|
Ege University | Dokuz Eylul University, Gazi University, Istanbul Saglik Bilimleri University, Izmir Katip Celebi University |
Turkey,
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
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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