PeriodontitisNCT04850768
(NOD)-Like Receptors CARD Domain-Containing 4 Levels in Individuals With Periodontitis
An observational study of Periodontitis and Gingivitis, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
NLRC4, an inflammasome , is a cytosolic multiprotein complex involved in the initiation and modulation of the immune response. 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… 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
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2021to 20 Sep 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 (NOD)-Like Receptors CARD Domain-containing 4 Levels in Individuals With Healthy and Periodontal Disease
NLRC4, an inflammasome , is a cytosolic multiprotein complex involved in the initiation and modulation of the immune response. 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. It has been said that proinflammatory cytokines released in the microenvironment of periodontitis can increase the expression of NLRC4 inflammasome genes. The authors think that NLRC4 may play a role in the periodontitis. The aim of this study is to compare the NLRC4, 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. Inflammasomes are cytosolic multiprotein complex involved in the initiation and modulation of the immune response.
Interleukine -1β ( IL-1β ) levels are associated with periodontal destruction in the pathogenesis of periodontal disease. Interleukine-10 (IL-10) has 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.
Both NLRC4 and NLRP3 inflammasomes have been shown to play an important role in the induction of interleukin-1β secretion. Periodontitis is induced by a complex microbial biofilm containing multiple Gram-positive and Gram-negative bacteria (including flagellate microorganisms) capable of activating a large number of NLRs. It has been said that proinflammatory cytokines released in the microenvironment of periodontitis can increase the expression of NLRC4 inflammasome genes. Evidence on the role of inflammasomes in periodontal disease is still very poor. The aim of this study is to compare the NLRC4, IL-1β and IL-10 levels of healthy and periodontitis individuals.
- Conditions
- Periodontitis, Gingivitis, Healthy
- Being tested
- Saliva, gingival crevicular fluid
- Keywords
- NLRC4
- 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 |
|---|---|---|
| Periodontitis | Individuals with Periodontitis Receives: Other: Saliva; Other: gingival crevicular fluid | |
| Gingivitis | Individuals with Gingival Inflammation Receives: Other: Saliva; Other: gingival crevicular fluid | |
| Healthy | Individuals with Periodontally Healthy 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 levels
saliva and DOS levels
Measured: through study completion, an average of 6 months
IL-10 levels
saliva and DOS levels
Measured: through study completion, an average of 6 months
NLRC4
saliva and DOS 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 posted20 Apr 2021
- Study start16 Apr 2021 (estimated)
- Primary completion20 Jul 2021 (estimated)
- Study completion20 Sep 2021 (estimated)
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.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Toraman, Saglik Bilimleri Universitesi
- Investigators
- Ayşe Toraman, Dr, Principal investigator, Saglik Bilimleri UniversitesiEbru Sağlam, 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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850768
- Sponsor's protocol ID
- 21-29
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- 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 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of (NOD)-Like Receptors CARD Domain-containing 4 Levels in Individuals With Healthy and Periodontal Disease
- ClinicalTrials.gov ID
- NCT04850768
- Acronym / sponsor ID
- 21-29
- Conditions
- Periodontitis, Gingivitis, Healthy
- Keywords
- NLRC4
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 16 Apr 2021 (estimated)
- Primary completion
- 20 Jul 2021 (estimated)
- Study completion
- 20 Sep 2021 (estimated)
- First posted
- 20 Apr 2021 (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.
NLRC4, an inflammasome , is a cytosolic multiprotein complex involved in the initiation and modulation of the immune response. 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. It has been said that proinflammatory cytokines released in the microenvironment of periodontitis can increase the expression of NLRC4 inflammasome genes. The authors think that NLRC4 may play a role in the periodontitis. The aim of this study is to compare the NLRC4, 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. Inflammasomes are cytosolic multiprotein complex involved in the initiation and modulation of the immune response.
Interleukine -1β ( IL-1β ) levels are associated with periodontal destruction in the pathogenesis of periodontal disease. Interleukine-10 (IL-10) has 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.
Both NLRC4 and NLRP3 inflammasomes have been shown to play an important role in the induction of interleukin-1β secretion. Periodontitis is induced by a complex microbial biofilm containing multiple Gram-positive and Gram-negative bacteria (including flagellate microorganisms) capable of activating a large number of NLRs. It has been said that proinflammatory cytokines released in the microenvironment of periodontitis can increase the expression of NLRC4 inflammasome genes. Evidence on the role of inflammasomes in periodontal disease is still very poor. The aim of this study is to compare the NLRC4, 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 |
|---|---|---|
| Periodontitis | – | Other: Saliva, Other: gingival crevicular fluidIndividuals with Periodontitis |
| Gingivitis | – | Other: Saliva, Other: gingival crevicular fluidIndividuals with Gingival Inflammation |
| Healthy | – | Other: Saliva, Other: gingival crevicular fluidIndividuals with Periodontally Healthy |
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 (1 listed)
- systemically healthy individuals who does not have a disease under treatment, individuals without regular systemic medication
Key exclusion criteria (1 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 levels
Time frame: through study completion, an average of 6 months
saliva and DOS levels
IL-10 levels
Time frame: through study completion, an average of 6 months
saliva and DOS levels
NLRC4
Time frame: through study completion, an average of 6 months
saliva and DOS 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- 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 principal investigator
Saglik Bilimleri Universitesi
Ebru Sağlam, Dr study chair
Saglik Bilimleri Universitesi
Serhat Köseoğlu, assoc prof study chair
Saglik Bilimleri Universitesi
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 Saglik Bilimleri Universitesi 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Toraman, Dr (05385025422, draysetoraman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-1β levels (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 20 Apr 2021.