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Clinical Trials/NCT05307068
NCT05307068CompletedNot Applicable

Investigation of the Relationships and Clinical Parameters Between IL-10, IL-12 and IL-18 Levels in the Gingival Crevicular Fluid of Individuals With Grade B-C Stage III-IV Periodontitis

Istanbul University1 site in 1 country60 target enrollmentStarted: April 15, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Measurement of GCF samples

Study Overview

Brief Summary

Periodontitis is a multifactorial chronic inflammatory disease characterized by the destruction of the tissues supporting the tooth. The incidence and rate of progression of periodontal destruction involves a complex interaction between periodontopathic bacteria and immune system cells. The complex cytokine network that mediates the immune response includes pro-inflammatory cytokines, anti-inflammatory cytokines, and specific cytokine receptors. Cytokines act as messengers to initiate, mediate, and control immune and inflammatory responses. It is known that the interaction of pro- and anti-inflammatory cytokines plays a very important role in the progression of periodontitis .

The immune response to infection is regulated by the balance between T helper (Th)1 and Th2-type cytokines. Since Th1, Th2, and monocyte-derived cytokines in gingival tissues and gingival crevicular fluid (GCF) play a role in periodontal inflammation, even a minimal imbalance in cytokine production may affect the induction of bone and collagen resorption in periodontal disease. For this reason, cytokines in inflamed periodontal tissues, which are the focus of many studies, are of great importance in the progression of periodontal disease.

In this study, our aim is to evaluate the local cytokine response in relation to the clinical periodontal status by determining the IL-10, IL-12 and IL-18 concentrations in the gingival crevicular fluid of individuals with grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions. In this way, besides clinical and radiographic determinations in the diagnosis of periodontal disease, IL-10, IL-12 and IL-18 are measured to evaluate whether these markers have an effect on the diagnosis of the disease.

Detailed Description

Interleukin-10 (IL-10) is one of the most potent anti-inflammatory cytokines, as it induces T cell anergy (non-responsiveness to an antigen) and reduces the production of some pro-inflammatory cytokines. Altered expression of IL-10, however, genetic predisposition and the presence of specific periodontal bacteria may contribute to the disruption of the Th1/Th2 balance and the development of aggressive periodontitis.

Interleukin-12 (IL-12) is a heterodimer comprised of p35 and p40 subunits, which form the bioactive IL-12 (p70). IL-12 is an essential mediator of the early innate immune response and a key inducer of cellular immunity. Its most important task is to stimulate T cells and interferon-γ (IFN-γ) production by natural killer cells, thereby promoting Th1 responses. The importance of IL-12 is not limited to initiating an immune response, it may contribute to the maintenance of immunity. Because in the absence of IL-12, Th1 responses are rapidly lost.

Interleukin-18 (IL-18) is a pro-inflammatory cytokine belonging to the IL-1 cytokine family. This cytokine was originally identified as a natural killer and a cytokine that induces IFN-γ produced by T cells. IL-18 acts synergistically with IL-12 to support IFN-γ production and Th1 cell growth, but does not depend on IL-12 for its activity.

When this information is brought together, the evaluation of the effects of IL-10, IL-12 and IL-18 concentrations in the gingival crevicular fluid on periodontal disease together with clinical parameters has been the point of our study.

It is planned to include 30 periodontally healthy individuals with grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions, who applied to Istanbul University Faculty of Dentistry Periodontology Department, after clinical and radiographic evaluations. All individuals to be included will be informed about the purpose and method of the study and their consent will be obtained.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Those with systemic modifying disease affecting periodontal status
  • Have received antibiotic therapy or immunosuppressive therapy in the last 6 months
  • Previously received periodontal treatment in the last 6 months
  • Pregnancy and breastfeeding status
  • Regular use of drugs that will affect systemic health

Outcomes

Primary Outcomes

Measurement of GCF samples

Time Frame: GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove

Measurement of IL-10, IL-12, IL-18 levels in GCF with grade B-C stage III-IV periodontitis individuals

Secondary Outcomes

  • Measurement of GCF samples(GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elif ilke Cebesoy

PhD student

Istanbul University

Study Sites (1)

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