Relationship Between Oral Findings and Salivary Factors in Sars-Cov-2 Patients
Condition: Decay, Dental; Missing Teeth; COVID-19; Cytokine Storm
MeSH terms: Tooth Loss; Anodontia; Dental Caries; Cytokine Release Syndrome
Study type: Interventional

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.
    

Intervention name(s): ELISA test for Cytokines
Intervention type(s): Diagnostic Test
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic