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Completed

NCT Number: NCT07497828

GCF and Saliva Levels of IL-36α in 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.

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Key information

Conditions

Periodontal Diseases Cytokine Gingival Crevicular Fluid Mouth Diseases Saliva Stomatognathic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordu University

Ordu, 52100, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of fluid samples

Diagnostic Test

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

Primary outcomes

  1. IL-36α levels

    Time frame: Baseline

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

Secondary outcomes

  1. Plaque index (PI)

    Time frame: Baseline

    to measure plaque level in all groups

  2. Gingival index (GI)

    Time frame: Baseline

    to measure the level of gingival inflammation in all groups

  3. Probing pocket depth (PPD)

    Time frame: Baseline

    to measure the level of soft and hard tissue destructionin all groups

  4. Clinical attachment level (CAL)

    Time frame: Baseline

    to measure the attachment loss level in all groups

  5. Bleeding on probing (BOP)

    Time frame: Baseline

    to measure the severity of bleeding in all groups

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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