Clinical trial NCT05476848: Relationship Between Oral Findings and Salivary Factors in Sars-Cov-2 Patients
Official title: Evaluation of Oral Health Status and Cytokine Levels in Sars-Cov-2 Hospitalized Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decay, Dental
Missing Teeth
COVID-19
Cytokine Storm
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Dokuz Eylul University
name: Izmir Katip Celebi University
name: Gazi University
name: Istanbul Saglik Bilimleri University
First posted: 2022-07-27
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: DMF Index
timeFrame: Baseline (1st appointment)
measure: Dental Plaque Status - GI
timeFrame: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
measure: Periodontal Bleeding Status - BoP
timeFrame: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
measure: Salivary Flow Rate
timeFrame: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
measure: Oral Cytokine Levels
timeFrame: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
measure: Oral Immunoglobulin Levels
timeFrame: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
Secondary outcomes:
measure: Age Range of the Participants
timeFrame: Baseline (1st appointment)
measure: Gender Distribution
timeFrame: Baseline (1st appointment)
measure: Systemical Diseases
timeFrame: Baseline (1st appointment)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
city: Izmir
country: Turkey
facility: Ege University
city: Izmir
country: Turkey
facility: Izmir Katip Celebi University
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Ege University Faculty of Dentistry
name: Cem Peskersoy
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.