- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05325905
Analysis of Gingival Crevicular Fluid (GCF)
Analysis of Gingival Crevicular Fluid IL-1β, IL-10, IL-36γ Cytokine Levels in Gingivitis and Periodontitis Patients
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Mehtikar Gürsel, Bezmialem University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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