Interleukin-38 Levels in Individuals With Periodontitis
Evaluation of Interleukin-38 Levels in Individuals With Healthy and Periodontal Disease
1 other identifier
observational
75
1 country
1
Brief Summary
Interleukin (IL)-38 is the newest member of the IL-1 family. It can bind to receptors through various pathways and regulate the formation and function of inflammatory cytokines. 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. The aim of this study is to compare the IL-38, IL-1β and IL-10 levels of healthy and periodontitis individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2022
CompletedStudy Start
First participant enrolled
September 30, 2022
CompletedFirst Posted
Study publicly available on registry
October 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2022
CompletedOctober 5, 2022
September 1, 2022
1 month
September 10, 2022
September 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
IL-38 levels
saliva and DOS levels
initial examination, baseline
IL-1β levels
saliva and DOS levels
initial examination, baseline
IL-10 levels
saliva and DOS levels
initial examination, baseline
Secondary Outcomes (3)
Plaque Index
initial examination, baseline
Probing Depth
initial examination, baseline
Bleeding on Probe
initial examination, baseline
Study Arms (3)
Periodontitis
Individuals with Periodontitis
Gingivitis
Individuals with Gingival Inflammation
Healthy
Individuals with Periodontally Healthy
Interventions
individuals' saliva samples will be collected and transferred to eppendorf tubes. Until biochemical analysis is carried out will be stored in -80ºC.
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.
Eligibility Criteria
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
- lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saglik Bilimleri Universitesi
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayşe Toraman, Dr
Saglik Bilimleri Universitesi
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2022
First Posted
October 5, 2022
Study Start
September 30, 2022
Primary Completion
November 10, 2022
Study Completion
December 10, 2022
Last Updated
October 5, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share