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

April 14, 2021 updated by: Ayse Toraman, Saglik Bilimleri Universitesi

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Saglik Bilimleri Universitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals will be divided into three different groups, about 20-25 people in each group.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Periodontitis
Individuals with Periodontitis
Other: Saliva

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

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

Other Names:
  • sampling
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.
Other Names:
  • sampling
Gingivitis
Individuals with Gingival Inflammation
Other: Saliva

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

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

Other Names:
  • sampling
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.
Other Names:
  • sampling
Healthy
Individuals with Periodontally Healthy
Other: Saliva

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

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

Other Names:
  • sampling
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.
Other Names:
  • sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-1β levels
Time Frame: through study completion, an average of 6 months
saliva and DOS levels
through study completion, an average of 6 months
IL-10 levels
Time Frame: through study completion, an average of 6 months
saliva and DOS levels
through study completion, an average of 6 months
NLRC4
Time Frame: through study completion, an average of 6 months
saliva and DOS levels
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: up to 20 weeks
Silness-Löe
up to 20 weeks
Probing Depth
Time Frame: up to 20 weeks
millimeter
up to 20 weeks
Bleeding on Probe
Time Frame: up to 20 weeks
Ainamo&Bay
up to 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Investigators

  • Principal Investigator: Ayşe Toraman, Dr, Saglik Bilimleri Universitesi
  • Study Chair: Ebru Sağlam, Dr, Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 16, 2021

Primary Completion (Anticipated)

July 20, 2021

Study Completion (Anticipated)

September 20, 2021

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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