NCT07497828

Brief Summary

Interleukin-36 (IL-36), recently identified and members of the IL-1 family, have been reported to be important regulators of host defense against pathogens in the oral mucosa. The aim of this study was to investigate the levels of IL-36 alpha (α) in saliva and gingival crevicular fluid (GCF) of patients with periodontitis, gingivitis and periodontally healthy individuals and to compare these levels with clinical parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 10, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

March 17, 2026

Last Update Submit

March 23, 2026

Conditions

Periodontal DiseasesSalivaGingival Crevicular FluidCytokine

Outcome Measures

Primary Outcomes (1)

  • IL-36α levels

    IL-36α levels in the gingival crevicular fluid (GCF) and saliva of the all groups

    Baseline

Secondary Outcomes (5)

  • Plaque index (PI)

    Baseline

  • Gingival index (GI)

    Baseline

  • Probing pocket depth (PPD)

    Baseline

  • Clinical attachment level (CAL)

    Baseline

  • Bleeding on probing (BOP)

    Baseline

Study Arms (4)

Control group

OTHER

Periodontally and systemically healthy individuals

Diagnostic Test: Collection of fluid samples

Gingivitis

OTHER

Systemically healthy and patients with Gingivitis

Diagnostic Test: Collection of fluid samples

Stage III Grade B Periodontitis

OTHER

systemically healthy and patients with Stage III Grade B periodontitis

Diagnostic Test: Collection of fluid samples

Stage III Grade C Periodontitis

OTHER

systemically healthy and patients with Stage III Grade C periodontitis

Diagnostic Test: Collection of fluid samples

Interventions

Collection of fluid samplesDIAGNOSTIC_TEST

Collection of Gingival crevicular fluid and saliva from all patients at baseline.

Control groupGingivitisStage III Grade B PeriodontitisStage III Grade C Periodontitis

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • at least 20 teeth
  • older than 18 years

You may not qualify if:

  • any systemic disease
  • pregnant or lactating
  • history of radiotherapy or chemotherapy
  • used antibiotics or any anti-inflammatory medication
  • smokers
  • had undergone periodontal treatment within the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 27, 2026

Study Start

December 10, 2023

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

No, sharing the IPD data is currently being considered.

Locations

TU(1)