(NOD)-Like Receptors CARD Domain-Containing 4 Levels in Individuals With Periodontitis

NCT ID: NCT04850768

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-16

Study Completion Date

2021-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontitis Gingivitis Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Periodontitis

Individuals with Periodontitis

Saliva

Intervention Type OTHER

individuals' saliva samples will be collected and transferred to eppendorf tubes.

Until biochemical analysis is carried out will be stored in -80ºC.

gingival crevicular fluid

Intervention Type OTHER

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.

Gingivitis

Individuals with Gingival Inflammation

Saliva

Intervention Type OTHER

individuals' saliva samples will be collected and transferred to eppendorf tubes.

Until biochemical analysis is carried out will be stored in -80ºC.

gingival crevicular fluid

Intervention Type OTHER

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.

Healthy

Individuals with Periodontally Healthy

Saliva

Intervention Type OTHER

individuals' saliva samples will be collected and transferred to eppendorf tubes.

Until biochemical analysis is carried out will be stored in -80ºC.

gingival crevicular fluid

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Saliva

individuals' saliva samples will be collected and transferred to eppendorf tubes.

Until biochemical analysis is carried out will be stored in -80ºC.

Intervention Type OTHER

gingival crevicular fluid

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

sampling sampling

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* systemically healthy individuals who does not have a disease under treatment, individuals without regular systemic medication

Exclusion Criteria

* smoking receiving periodontal treatment in the last 6 months pregnancy menopausal or menstrual period
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ayse Toraman

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ayşe Toraman, Dr

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Ebru Sağlam, Dr

Role: STUDY_CHAIR

Saglik Bilimleri Universitesi

Serhat Köseoğlu, assoc prof

Role: STUDY_CHAIR

Saglik Bilimleri Universitesi

Mehmet Sağlam, assoc prof

Role: STUDY_CHAIR

Izmir Katip Celebi University

Levent Savran, PhD

Role: STUDY_CHAIR

Izmir Katip Celebi University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Saglik Bilimleri Universitesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ayşe Toraman, Dr

Role: CONTACT

05385025422

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21-29

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

I-Smads in Periodontitis
NCT04846166 COMPLETED