PeriodontitisNCT04402996
Meteorin-like Levels in Individuals With Periodontitis
An observational study of Periodontitis and Gingivitis, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
Metrnl has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a role in the pathogenesis of human inflammatory diseases. Metrnl is highly expressed from the oral mucosa to the esophagus. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis, Healthy
- What is being tested?
- Saliva and gingival crevicular fluid
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Sep 2020to 3 Mar 2021
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals will be divided into three different groups, about 20-25 people in each group.
Who may be able to join
- systemically healthy
- individuals who does not have a disease under treatment,
- individuals without regular systemic medication
Who cannot join
- smoking
- receiving periodontal treatment in the last 6 months
- pregnancy
- menopausal or menstrual period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Meteorin-like Levels in Individuals With Healthy and Periodontal Disease
Metrnl has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a role in the pathogenesis of human inflammatory diseases. Metrnl is highly expressed from the oral mucosa to the esophagus. Periodontitis is a chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. The authors think that Metrnl may play a role in the periodontitis. The aim of this study is to compare the Metrnl, IL-1β, and IL-10 levels of healthy and periodontitis individuals.
Read the detailed description
Periodontitis is a destructive chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. Cytokines play an important role in inflammation that occurs in periodontal disease.
Interleukine -1β ( IL-1β ) levels are associated with periodontal destruction in the pathogenesis of periodontal disease. Cytokines such as Interleukine-10 (IL-10) and transforming growth factor- β (TGF-β) have been reported to decrease periodontal disease progression rate.
Gingival crevicular fluid shows the cellular response in the periodontium. The most important host-related ingredients are inflammatory markers, including cytokines, enzymes, and interleukins. Saliva analysis is used in the diagnosis of systemic conditions as well as in the diagnosis of oral pathologies.
Meteorin- like (Metrnl) is a protein that plays a role in natural and acquired immune-related functions and inflammatory responses, and expressed in barrier tissues (skin and mucosa) as well as various macrophage populations, from dendritic cells and some granulocytes. Metrnl has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a role in the pathogenesis of human inflammatory diseases. Metrnl, which is highly expressed from the oral mucosa to the esophagus, may play a role in the onset of periodontitis and an effective marker in preventing the progression of destruction. We think that Metrnl plays an important role in periodontitis, an inflammatory disease. The aim of this study is to compare the Metrnl, IL-1β, and IL-10 levels of healthy and periodontitis individuals
- Conditions
- Periodontitis, Gingivitis, Healthy
- Being tested
- Saliva, gingival crevicular fluid
- Keywords
- Meteorin-like
- Medical subject headings
- Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalivaOther
Also called sampling
individuals' saliva samples will be collected and transferred to eppendorf tubes.
Until biochemical analysis is carried out will be stored in -80ºC.
gingival crevicular fluidOther
Also called sampling
GCF samples of individuals will be collected by paper strips and transferred to eppendorf tubes.
Until biochemical analysis is carried out will be stored in -80ºC.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Individuals with Periodontally Healthy Receives: Other: Saliva; Other: gingival crevicular fluid | |
| Gingivitis | Individuals with Gingival Inflammation Receives: Other: Saliva; Other: gingival crevicular fluid | |
| Periodontitis | Individuals with Periodontitis Receives: Other: Saliva; Other: gingival crevicular fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-1β
saliva and serum levels
Measured: through study completion, an average of 6 months
Metrnl
saliva and serum levels
Measured: through study completion, an average of 6 months
IL-10 levels
saliva and serum levels
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
Plaque Index
Silness-Löe
Measured: up to 20 weeks
Probing Depth
millimeter
Measured: up to 20 weeks
Bleeding on Probe
Ainamo\&Bay
Measured: up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start23 Sep 2020
- Primary completion3 Mar 2021
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru SAĞLAM, Istanbul Saglik Bilimleri University
- Investigators
- Ayşe Toraman, Dr., Study chair, Saglik Bilimleri UniversitesiSerhat Köseoğlu, assoc prof, Study chair, Saglik Bilimleri UniversitesiMehmet Sağlam, assoc prof, Study chair, Izmir Katip Celebi UniversityLevent Savran, PhD, Study chair, Izmir Katip Celebi UniversityEbru Sağlam, Dr, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402996
- Sponsor's protocol ID
- Sağlık Bilimleri Üniversitesi
- Status last verified
- Apr 2024
- First submitted
- 19 May 2020
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Meteorin-like Levels in Individuals With Healthy and Periodontal Disease
- ClinicalTrials.gov ID
- NCT04402996
- Acronym / sponsor ID
- Sağlık Bilimleri Üniversitesi
- Conditions
- Periodontitis, Gingivitis, Healthy
- Keywords
- Meteorin-like
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 27 May 2020 (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.
Metrnl has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a role in the pathogenesis of human inflammatory diseases. Metrnl is highly expressed from the oral mucosa to the esophagus. Periodontitis is a chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. The authors think that Metrnl may play a role in the periodontitis. The aim of this study is to compare the Metrnl, IL-1β, and IL-10 levels of healthy and periodontitis individuals.
Detailed description
Periodontitis is a destructive chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. Cytokines play an important role in inflammation that occurs in periodontal disease.
Interleukine -1β ( IL-1β ) levels are associated with periodontal destruction in the pathogenesis of periodontal disease. Cytokines such as Interleukine-10 (IL-10) and transforming growth factor- β (TGF-β) have been reported to decrease periodontal disease progression rate.
Gingival crevicular fluid shows the cellular response in the periodontium. The most important host-related ingredients are inflammatory markers, including cytokines, enzymes, and interleukins. Saliva analysis is used in the diagnosis of systemic conditions as well as in the diagnosis of oral pathologies.
Meteorin- like (Metrnl) is a protein that plays a role in natural and acquired immune-related functions and inflammatory responses, and expressed in barrier tissues (skin and mucosa) as well as various macrophage populations, from dendritic cells and some granulocytes. Metrnl has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a role in the pathogenesis of human inflammatory diseases. Metrnl, which is highly expressed from the oral mucosa to the esophagus, may play a role in the onset of periodontitis and an effective marker in preventing the progression of destruction. We think that Metrnl plays an important role in periodontitis, an inflammatory disease. The aim of this study is to compare the Metrnl, IL-1β, and IL-10 levels of healthy and periodontitis individuals
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Other: Saliva, Other: gingival crevicular fluidIndividuals with Periodontally Healthy |
| Gingivitis | – | Other: Saliva, Other: gingival crevicular fluidIndividuals with Gingival Inflammation |
| Periodontitis | – | Other: Saliva, Other: gingival crevicular fluidIndividuals with Periodontitis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals will be divided into three different groups, about 20-25 people in each group.
Key inclusion criteria (3 listed)
- systemically healthy
- individuals who does not have a disease under treatment,
- individuals without regular systemic medication
Key exclusion criteria (4 listed)
- smoking
- receiving periodontal treatment in the last 6 months
- pregnancy
- menopausal or menstrual period
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 |
|---|---|---|
| SalivaAlso: samplingindividuals' saliva samples will be collected and transferred to eppendorf tubes. Until biochemical analysis is carried out will be stored in -80ºC. | Other | Gingivitis, Healthy, Periodontitis |
| gingival crevicular fluidAlso: samplingGCF samples of individuals will be collected by paper strips and transferred to eppendorf tubes. Until biochemical analysis is carried out will be stored in -80ºC. | Other | Gingivitis, Healthy, Periodontitis |
Primary outcome
IL-1β
Time frame: through study completion, an average of 6 months
saliva and serum levels
Metrnl
Time frame: through study completion, an average of 6 months
saliva and serum levels
IL-10 levels
Time frame: through study completion, an average of 6 months
saliva and serum levels
3 secondary outcomes
Plaque Index
Time frame: up to 20 weeks
Probing Depth
Time frame: up to 20 weeks
Bleeding on Probe
Time frame: up to 20 weeks
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 29 Apr 2024.
- 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.
Ayşe Toraman, Dr. study chair
Saglik Bilimleri Universitesi
Serhat Köseoğlu, assoc prof study chair
Saglik Bilimleri Universitesi
Mehmet Sağlam, assoc prof study chair
Izmir Katip Celebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Gingivitis, run by Istanbul Saglik Bilimleri University at 1 site 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
IL-1β (time frame: through study completion, an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2024.