Clinical trial NCT04850768: (NOD)-Like Receptors CARD Domain-Containing 4 Levels in Individuals With Periodontitis
Official title: Evaluation of (NOD)-Like Receptors CARD Domain-containing 4 Levels in Individuals With Healthy and Periodontal Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Gingivitis
Healthy
Keywords: NLRC4
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals will be divided into three different groups, about 20-25 people in each group.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: IL-1β levels
timeFrame: through study completion, an average of 6 months
measure: IL-10 levels
timeFrame: through study completion, an average of 6 months
measure: NLRC4
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Plaque Index
timeFrame: up to 20 weeks
measure: Probing Depth
timeFrame: up to 20 weeks
measure: Bleeding on Probe
timeFrame: up to 20 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri Universitesi
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Ayşe Toraman, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi
name: Ebru Sağlam, Dr
role: STUDY_CHAIR
affiliation: Saglik Bilimleri Universitesi
name: Serhat Köseoğlu, assoc prof
role: STUDY_CHAIR
affiliation: Izmir Katip Celebi University
name: Mehmet Sağlam, assoc prof
role: STUDY_CHAIR
affiliation: Izmir Katip Celebi University
name: Levent Savran, PhD
role: STUDY_CHAIR
References: