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NCT Number: NCT05476848

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

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.

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Key information

Conditions

Decay, Dental Anodontia COVID-19 Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronaviridae Infections Coronavirus Infections Cytokine Release Syndrome Cytokine Storm Dental Caries Infections Inflammation Lung Diseases Missing Teeth Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Shock Stomatognathic Diseases Stomatognathic System Abnormalities Systemic Inflammatory Response Syndrome Tooth Abnormalities Tooth Demineralization Tooth Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University, Ankara, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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.

Primary outcomes

  1. DMF Index

    Time frame: Baseline (1st appointment)

    Decay, Missing, Filled teeth scores will be recorded and evaluated for both study groups.

  2. Dental Plaque Status - GI

    Time frame: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)

    Gingival Index scores (visible dental plaque) will be evaluated for both study groups.

  3. Periodontal Bleeding Status - BoP

    Time frame: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)

    Bleeding volume (ml/sec) on probing will be evaluated for both study groups.

  4. Salivary Flow Rate

    Time frame: 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).

  5. Oral Cytokine Levels

    Time frame: 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).

  6. Oral Immunoglobulin Levels

    Time frame: 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 outcomes

  1. Age Range of the Participants

    Time frame: 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).

  2. Gender Distribution

    Time frame: 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.

  3. Systemical Diseases

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

  • Dokuz Eylul University
  • Gazi University
  • Istanbul Saglik Bilimleri University
  • Izmir Katip Celebi University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 27, 2022
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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