Analysis of Gingival Crevicular Fluid (GCF)

April 6, 2022 updated by: Mehtikar Gursel, Bezmialem Vakif University

Analysis of Gingival Crevicular Fluid IL-1β, IL-10, IL-36γ Cytokine Levels in Gingivitis and Periodontitis Patients

The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.

Study Overview

Status

Completed

Detailed Description

Gingival crevicular fluid (GCF) is formed when fluid exudes from the vessels of the microcirculation into the inflamed periodontal tissue and into the sulcus or pocket. As the fluid traverses the inflamed tissue, it is thought to pick up enzymes and other molecules that participate in the destructive process, as well as products of cell and tissue degradation. Efforts to develop diagnostic tests based on host factors have been focused almost entirely on analysis of GCF.

The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.

Systemically healthy and non-smokers 80 participants (30 males and 50 females) who were selected from among admitting to Dentistry Faculty of Selcuk University were included in this study. Clinical periodontal parameters were recorded and GCF samples were obtained. Samples were stored in -80 ˚C until analysis with Enzyme-Linked ImmunoSorbent Assay (ELISA).

Study Type

Observational

Enrollment (Actual)

81

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients were selected from among admitting to Dentistry Faculty of Selcuk University.

Description

Inclusion Criteria:

  • Systemically healthy
  • non-smokers,
  • presence of at least 20 teeth in the mouth

Exclusion Criteria:

  • receiving periodontal therapy in the last 6 months;
  • receiving antibiotics or anti-inflammatory drugs in the last 6 months;
  • currently pregnant or breastfeeding
  • using a removable partial denture and removable or fixed orthodontic appliances.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy
bleeding on probing (BoP) ≤ 10% of the sites, probing depth (PD) ≤ 3 mm and no indication of clinical attachment level (CAL) or radiographic bone loss
GCF sampling and clinical periodontal measurements were performed
Gingivitis
gingival inflammation (BoP ≥ 10% of the sites, red-blue discoloration of the gingiva and edema) PD ≤ 4 mm and no clinical attachment or radiographic bone loss
GCF sampling and clinical periodontal measurements were performed
Periodontitis
PD ≤ 5 mm, radiographic bone loss, and 3-4 mm CAL in at least 30% of the sites
GCF sampling and clinical periodontal measurements were performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin-36γ (IL-36γ) levels in GCF
Time Frame: Baseline
GCF samples were obtained from one interproximal site in each quadrant
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth (PD)
Time Frame: Baseline
PD; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars.
Baseline
Clinical attachment level (CAL)
Time Frame: Baseline
CAL; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars.
Baseline
Bleeding on Probing (BoP)
Time Frame: Baseline
BoP, from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars
Baseline
IL-10 and IL-1β levels in GCF
Time Frame: Baseline
GCF samples were obtained from one interproximal site in each quadrant
Baseline
Plaque Index (PI)
Time Frame: Baseline
PI; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars
Baseline
Gingival Index (GI)
Time Frame: Baseline
GI; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Mehtikar Gürsel, Bezmialem University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2014/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Results will be shared if requested

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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