Decay, DentalNCT05476848
Relationship Between Oral Findings and Salivary Factors in Sars-Cov-2 Patients
A study testing ELISA test for Cytokines in people with Decay, Dental and Missing Teeth, run by Ege University at 4 sites in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Decay, Dental, Missing Teeth, COVID-19
- What is being tested?
- ELISA test for Cytokines
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.).
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Gazi University
Ankara, 06500
Ege University
Izmir, 35100
Izmir Katip Celebi University
Izmir, 35400
Dokuz Eylul University
Izmir, 35600
About this study
Official title: Evaluation of Oral Health Status and Cytokine Levels in Sars-Cov-2 Hospitalized Patients: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Decay, Dental, Missing Teeth, COVID-19, Cytokine Storm
- Being tested
- ELISA test for Cytokines
- Medical subject headings
- Dental Caries, Anodontia, COVID-19, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA test for CytokinesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 (+) Patients | Experimental | Oral Examination, Radiography, oral (salivary) swap sample collection will be performed. Receives: Diagnostic Test: ELISA test for Cytokines |
| Healthy Individuals | Active comparator | Oral Examination, Radiography, oral (salivary) swap sample collection will be performed. Receives: Diagnostic Test: ELISA test for Cytokines |
What is being measured
The primary outcome is the main question the study is designed to answer.
DMF Index
Decay, Missing, Filled teeth scores will be recorded and evaluated for both study groups.
Measured: Baseline (1st appointment)
Dental Plaque Status - GI
Gingival Index scores (visible dental plaque) will be evaluated for both study groups.
Measured: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
Periodontal Bleeding Status - BoP
Bleeding volume (ml/sec) on probing will be evaluated for both study groups.
Measured: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
Salivary Flow Rate
Salivary flow rate of each participant is calculated by measuring the unstimulated saliva volume (ml/min).
Measured: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
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).
Measured: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
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).
Measured: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
Secondary outcomes (3)
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).
Measured: Baseline (1st appointment)
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.
Measured: Baseline (1st appointment)
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.
Measured: Baseline (1st appointment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Mar 2022
- Primary completion10 Aug 2022
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Decay, DentalStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Dokuz Eylul University, Izmir Katip Celebi University, Gazi University, Istanbul Saglik Bilimleri University
- Responsible party
- Principal investigator, Cem Peskersoy, Ege University
- Investigators
- Cem Peskersoy, Principal investigator, Ege University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476848
- Sponsor's protocol ID
- 21-6.1T/70
- Status last verified
- Aug 2023
- First submitted
- 25 May 2022
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35502340Peskersoy 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.
PubMed 27513246Alfaifi 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.
PubMed 35310855
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Health Status and Cytokine Levels in Sars-Cov-2 Hospitalized Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05476848
- Acronym / sponsor ID
- 21-6.1T/70
- Conditions
- Decay, Dental, Missing Teeth, COVID-19, Cytokine Storm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Dokuz Eylul University, Izmir Katip Celebi University, Gazi University, Istanbul Saglik Bilimleri University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 (+) Patients | Experimental | Diagnostic Test: ELISA test for CytokinesOral Examination, Radiography, oral (salivary) swap sample collection will be performed. |
| Healthy Individuals | Active comparator | Diagnostic Test: ELISA test for CytokinesOral Examination, Radiography, oral (salivary) swap sample collection will be performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA test for CytokinesELISA 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. | Diagnostic test | Covid-19 (+) Patients, Healthy Individuals |
Primary outcome
DMF Index
Time frame: Baseline (1st appointment)
Decay, Missing, Filled teeth scores will be recorded and evaluated for both study groups.
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.
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.
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).
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).
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).
3 secondary outcomes
Age Range of the Participants
Time frame: Baseline (1st appointment)
Gender Distribution
Time frame: Baseline (1st appointment)
Systemical Diseases
Time frame: Baseline (1st appointment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 35502340Peskersoy 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.
- Background: PubMed 27513246Peskersoy 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.
- Background: PubMed 35310855Alfaifi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cem Peskersoy principal investigator
Ege University Faculty of Dentistry
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELISA test for Cytokines in people with Decay, Dental and Missing Teeth, run by Ege University at 4 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DMF Index (time frame: Baseline (1st appointment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05476848, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.