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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05476848
• Other study ID #: 21-6.1T/70
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: August 10, 2023

Study information

• Verified date: August 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.).

Related Conditions & MeSH terms

• Anodontia
• COVID-19
• Cytokine Release Syndrome
• Cytokine Storm
• Decay, Dental
• Dental Caries
• Missing Teeth
• Tooth Loss

Intervention

Diagnostic Test:
• ELISA test for Cytokines
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.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara
Turkey	Dokuz Eylul University	Izmir
Turkey	Ege University	Izmir
Turkey	Izmir Katip Celebi University	Izmir

Sponsors (5)

Lead Sponsor	Collaborator
Ege University	Dokuz Eylul University, Gazi University, Istanbul Saglik Bilimleri University, Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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

Outcome

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)