Skip to main content
OpenTrials
Completed

NCT Number: NCT05325905

Analysis of Gingival Crevicular Fluid

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Gingival crevicular fluid sampling

Diagnostic Test

GCF sampling and clinical periodontal measurements were performed

Primary outcomes

  1. Interleukin-36γ (IL-36γ) levels in GCF

    Time frame: Baseline

    GCF samples were obtained from one interproximal site in each quadrant

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. IL-10 and IL-1β levels in GCF

    Time frame: Baseline

    GCF samples were obtained from one interproximal site in each quadrant

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Collaborators

  • Selcuk University

Registry information

Official study title

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

Acronym: GCF

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Apr 13, 2022
Registry last updated
Apr 13, 2022

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.

Published trials that share one or more normalized conditions with this study.