GCF: Analysis of Gingival Crevicular Fluid

Sponsor

Bezmialem Vakif University (Other)

Overall Status

Completed

CT.gov ID

NCT05325905

Collaborator

Selcuk University (Other)

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Diseases	Diagnostic Test: Gingival crevicular fluid sampling

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.

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 Design

Study Type:

Observational

Actual Enrollment :

81 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	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	Diagnostic Test: Gingival crevicular fluid sampling 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	Diagnostic Test: Gingival crevicular fluid sampling 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	Diagnostic Test: Gingival crevicular fluid sampling GCF sampling and clinical periodontal measurements were performed

Arm

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

Diagnostic Test: Gingival crevicular fluid sampling

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

Diagnostic Test: Gingival crevicular fluid sampling

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

Diagnostic Test: Gingival crevicular fluid sampling

GCF sampling and clinical periodontal measurements were performed

Outcome Measures

Primary Outcome Measures

Interleukin-36γ (IL-36γ) levels in GCF [Baseline]
GCF samples were obtained from one interproximal site in each quadrant

Secondary Outcome Measures

Probing depth (PD) [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.
Clinical attachment level (CAL) [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.
Bleeding on Probing (BoP) [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
IL-10 and IL-1β levels in GCF [Baseline]
GCF samples were obtained from one interproximal site in each quadrant
Plaque Index (PI) [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
Gingival Index (GI) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Bezmialem Vakif University
Selcuk University

Investigators

Principal Investigator: Mehtikar Gürsel, Bezmialem University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mehtikar Gursel, Prof.Dr, Bezmialem Vakif University

ClinicalTrials.gov Identifier:

NCT05325905

Other Study ID Numbers:

2014/01

First Posted:

Apr 13, 2022

Last Update Posted:

Apr 13, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mehtikar Gursel, Prof.Dr, Bezmialem Vakif University

pathogenesis

Gingival crevicular fluid

cytokine

Additional relevant MeSH terms:

Periodontal Diseases

Study Results

No Results Posted as of Apr 13, 2022