NCT04850768

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

April 16, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 14, 2021

Last Update Submit

April 14, 2021

Conditions

PeriodontitisGingivitisHealthy

Keywords

NLRC4

Outcome Measures

Primary Outcomes (3)

  • IL-1β levels

    saliva and DOS levels

    through study completion, an average of 6 months

  • IL-10 levels

    saliva and DOS levels

    through study completion, an average of 6 months

  • NLRC4

    saliva and DOS levels

    through study completion, an average of 6 months

Secondary Outcomes (3)

  • Plaque Index

    up to 20 weeks

  • Probing Depth

    up to 20 weeks

  • Bleeding on Probe

    up to 20 weeks

Study Arms (3)

Periodontitis

Individuals with Periodontitis

Other: SalivaOther: gingival crevicular fluid

Gingivitis

Individuals with Gingival Inflammation

Other: SalivaOther: gingival crevicular fluid

Healthy

Individuals with Periodontally Healthy

Other: SalivaOther: gingival crevicular fluid

Interventions

SalivaOTHER

individuals' saliva samples will be collected and transferred to eppendorf tubes. Until biochemical analysis is carried out will be stored in -80ºC.

Also known as: sampling
GingivitisHealthyPeriodontitis
gingival crevicular fluidOTHER

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.

Also known as: sampling
GingivitisHealthyPeriodontitis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • smoking receiving periodontal treatment in the last 6 months pregnancy menopausal or menstrual period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and gingival crevicular fluid

MeSH Terms

Conditions

PeriodontitisGingivitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Officials

  • Ayşe Toraman, Dr

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

  • Ebru Sağlam, Dr

    Saglik Bilimleri Universitesi

    STUDY CHAIR

  • Serhat Köseoğlu, assoc prof

    Saglik Bilimleri Universitesi

    STUDY CHAIR

  • Mehmet Sağlam, assoc prof

    Izmir Katip Celebi University

    STUDY CHAIR

  • Levent Savran, PhD

    Izmir Katip Celebi University

    STUDY CHAIR

Central Study Contacts

Ayşe Toraman, Dr

CONTACT

05385025422draysetoraman@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 20, 2021

Study Start

April 16, 2021

Primary Completion

July 20, 2021

Study Completion

September 20, 2021

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)