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

Healthy Clinical Trial

Official title:

Evaluation of (NOD)-Like Receptors CARD Domain-containing 4 Levels in Individuals With Healthy and Periodontal Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04850768
• Other study ID #: 21-29
• Status: Not yet recruiting
• Start date: April 16, 2021
• Est. completion date: September 20, 2021

Study information

• Verified date: April 2021
• Source: Saglik Bilimleri Universitesi
• Contact: Ayse Toraman, Dr
• Phone: 05385025422
• Email: draysetoraman[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: September 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Healthy
• Periodontitis

Intervention

Other:
• Saliva
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
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.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Universitesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-1ß levels	saliva and DOS levels	through study completion, an average of 6 months
Primary	IL-10 levels	saliva and DOS levels	through study completion, an average of 6 months
Primary	NLRC4	saliva and DOS levels	through study completion, an average of 6 months
Secondary	Plaque Index	Silness-Löe	up to 20 weeks
Secondary	Probing Depth	millimeter	up to 20 weeks
Secondary	Bleeding on Probe	Ainamo&Bay	up to 20 weeks