Relationship Between Oral Findings and Salivary Factors in Sars-Cov-2 Patients
- Conditions
- Decay, DentalCOVID-19Missing TeethCytokine Storm
- Interventions
- Diagnostic Test: ELISA test for Cytokines
- Registration Number
- NCT05476848
- Lead Sponsor
- Ege University
- 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
- 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).
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy Individuals ELISA test for Cytokines Oral Examination, Radiography, oral (salivary) swap sample collection will be performed. Covid-19 (+) Patients ELISA test for Cytokines Oral Examination, Radiography, oral (salivary) swap sample collection will be performed.
- Primary Outcome Measures
Name Time Method Dental Plaque Status - GI Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment) Gingival Index scores (visible dental plaque) will be evaluated for both study groups.
DMF Index Baseline (1st appointment) Decay, Missing, Filled teeth scores will be recorded and evaluated for both study groups.
Salivary Flow Rate Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment) Salivary flow rate of each participant is calculated by measuring the unstimulated saliva volume (ml/min).
Periodontal Bleeding Status - BoP Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment) Bleeding volume (ml/sec) on probing will be evaluated for both study groups.
Oral Cytokine Levels Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment) 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).
Oral Immunoglobulin Levels Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment) and immunoglobulin levels will be evaluated for both study groups three times, due to the half-life of specific markers (IgA, IgG, IgM).
- Secondary Outcome Measures
Name Time Method Systemical Diseases Baseline (1st appointment) 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.
Age Range of the Participants Baseline (1st appointment) 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).
Gender Distribution Baseline (1st appointment) 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.
Trial Locations
- Locations (4)
Gazi University
🇹🇷Ankara, Turkey
Izmir Katip Celebi University
🇹🇷Izmir, Turkey
Ege University
🇹🇷Izmir, Turkey
Dokuz Eylul University
🇹🇷İzmir, Turkey