NCT05568290

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

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 Sep 2022

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

September 10, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
Last Updated

October 5, 2022

Status Verified

September 1, 2022

Enrollment Period

1 month

First QC Date

September 10, 2022

Last Update Submit

September 30, 2022

Conditions

Keywords

periodontal diseaseIL-38

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

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

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
  • lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PeriodontitisGingivitisPeriodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Officials

  • Ayşe Toraman, Dr

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe Toraman, Dr

CONTACT

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

Locations