GCF and Saliva Levels of IL-36α in Periodontal Disease

IL-36α Levels in Saliva and Gingival Crevicular Fluid of the Patients With Periodontal Disease

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Cytokine; Saliva; Gingival Crevicular Fluid
• Intervention / Treatment: Diagnostic test: Collection of fluid samples

Detailed Description

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.

Materials and Methods: A total of 80 systemically healthy, non-smokers aged between 25 and 55 including 20 periodontally healthy individuals, 20 individuals with gingivitis, 20 individuals with Stage III Grade B periodontitis, and 20 individuals with Stage III Grade C periodontitis were involved in our study. Clinical parameters, including plaque index (PI), gingival index (GI), probing pocket depth (PPD), clinical attachment level (CAL), and bleeding on probing (BOP), were recorded. GCF and unstimulated saliva samples were collected from all participants. IL-36α levels were quantified using enzyme-linked immunosorbent assay (ELISA).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ordu, Turkey (Türkiye), 52100
    • Ordu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• at least 20 teeth
• older than 18 years

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Periodontally and systemically healthy individuals	Diagnostic test: Collection of fluid samples; Collection of Gingival crevicular fluid and saliva from all patients at baseline.
Other: Gingivitis; Systemically healthy and patients with Gingivitis	Diagnostic test: Collection of fluid samples; Collection of Gingival crevicular fluid and saliva from all patients at baseline.
Other: Stage III Grade B Periodontitis; systemically healthy and patients with Stage III Grade B periodontitis	Diagnostic test: Collection of fluid samples; Collection of Gingival crevicular fluid and saliva from all patients at baseline.
Other: Stage III Grade C Periodontitis; systemically healthy and patients with Stage III Grade C periodontitis	Diagnostic test: Collection of fluid samples; Collection of Gingival crevicular fluid and saliva from all patients at baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IL-36α levels	IL-36α levels in the gingival crevicular fluid (GCF) and saliva of the all groups	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index (PI)	to measure plaque level in all groups	Baseline
Gingival index (GI)	to measure the level of gingival inflammation in all groups	Baseline
Probing pocket depth (PPD)	to measure the level of soft and hard tissue destructionin all groups	Baseline
Clinical attachment level (CAL)	to measure the attachment loss level in all groups	Baseline
Bleeding on probing (BOP)	to measure the severity of bleeding in all groups	Baseline

Collaborators and Investigators

• Sponsor: Ordu University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2023
• Primary Completion (Actual): January 10, 2025
• Study Completion (Actual): January 10, 2025

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases
• Other Study ID Numbers: 2023\314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No, sharing the IPD data is currently being considered.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No