GCF Levels of IL-1β and IL-6 in Gingivitis and Stage III-Grade C Periodontitis

Usak University Faculty of Dentistry

Periodontal diseases are chronic diseases that occur as a result of a violation of the balance between microbial dental plaque and the host response. Gingivitis is a disease characterized by inflammation of the gingiva that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event that begins in the gingiva along with gingivitis spreads to the periodontal ligament, alveolar bone and soft tissues that support the tooth, causing the destruction of these structures.2 Cytokines are low molecular weight proteins that participate in the initial and active stages of inflammation and immunity. In periodontal disease pathogenesis, cytokine response has been reported to play a very critical role in determining disease progression.3 IL-1beta and IL-6 are key cytokines in chronic inflammatory diseases and have the potential to initiate bone loss and tissue destruction seen in periodontal disease.4the purpose of this study; it is to determine the degree of inflammation and periodontal destruction by determining the levels of IL-1beta and IL-6 cytokines in the gingival crevicular fluid of periodontal healthy and diseased individuals.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Diagnostic test: gingival crevicular fluid

Detailed Description

Periodontal measurement were done at 6 sites per tooth After clinical evaluation, individuals were divided into 3 groups

1. Healthy control groups:

   clinically healthy gingiva

2. Gingivitis groups:

   BOP score of 10% or greater and PD≤3mm

3. Periodontitis groups:

AL ≥5 mm, PD≥6 mm and tooth loss due to periodontitis of ≤4. GCF samples were collected using strips.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Turkey
  • Uşak, Turkey, 64200
    • University of Usak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

individuals who have periodontal disease will be selected

Description

Inclusion Criteria:

• have periodontitis
• have 16 permanent teeth

Exclusion Criteria:

• Systemic disease
• using drugs

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy control groups; clinically healthy gingiva BOP score less than 10%	Diagnostic test: gingival crevicular fluid; GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.
Gingivitis groups; BOP score of 10% or greater	Diagnostic test: gingival crevicular fluid; GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.
Periodontitis groups; interdental AL ≥5 mm, PD≥6 mm	Diagnostic test: gingival crevicular fluid; GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of IL-1Beta level	GCF was taken interproximal region.	GCF was taken within 1 week after clinical examination
Measurement of IL-6 level in GCF	GCF was taken interproximal region.	GCF was taken within 1 week after clinical examination

Collaborators and Investigators

• Sponsor: Uşak University
• Investigators: Principal Investigator: ahu dikilitaş, University of Usak; Study Chair: fatih karaaslan, University of Usak; Study Chair: abdullah seçkin ertuğrul, University of IZMIR KATİP CELEBİ

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): December 25, 2020
• Study Completion (Actual): December 28, 2020

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: periodontitis; cytokines; periodontal disease; gingivitis
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontitis; Gingivitis
• Other Study ID Numbers: UsakU7

Drug and device information, study documents

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