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CompletedNCT05435131Updated Jul 1, 2022

Evaluation of Biomarkers Levels in Gingival Crevicular Fluid, Saliva and Serum for Different Periodontal Diseases

An interventional study of GCF obtaining and Saliva Obtaining in Mouth Diseases, Periodontal Inflammation and Periodontal Diseases, sponsored by Akdeniz University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-01.

Sponsored by Akdeniz University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Jun 2020, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The aim of this study is; detection of interleukin(IL)-38, IL-36 gamma(γ) , IL-17 and matrix metalloproteinase(MMP)-9 levels in gingival crevicular fluid (GCF), saliva and serum samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. Materials and methods: Samples were obtained from 90 systemically healthy non-smoker individuals with periodontitis (P, n=30), gingivitis(G, n=30) and healthy periodontium (S, n=30). Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine IL-38, IL-36γ, IL-17 and MMP-9 levels in the biological samples.

02

Conditions studied

  • Mouth Diseases
  • Periodontal Inflammation
  • Periodontal Diseases
03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 90 is above the median of 45 across 530 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)
  • At least twenty permanent teeth in the mouth
  • Non-smoker
  • No medication for continuous use
  • Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
  • Not in pregnancy or lactation period.
  • For the periodontitis group that has not received periodontal treatment in the last 6 months

Exclusion criteria

Exclusion Criteria:

  • Any oral or systemic disease
  • Regularly using a systemic medication
  • During pregnancy or lactation
  • Received periodontal treatment within the last 6 months.
  • Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
  • Smokers
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Periodontal Health

    Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.

    Diagnostic Test: GCF obtaining · Diagnostic Test: Saliva Obtaining · Diagnostic Test: Serum obtaining

  • Experimental
    Gingivitis

    Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.

    Diagnostic Test: GCF obtaining · Diagnostic Test: Saliva Obtaining · Diagnostic Test: Serum obtaining

  • Experimental
    Stage II grade B Periodontitis

    Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.

    Diagnostic Test: GCF obtaining · Diagnostic Test: Saliva Obtaining · Diagnostic Test: Serum obtaining

  • Experimental
    Stage III grade B Periodontitis

    Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.

    Diagnostic Test: GCF obtaining · Diagnostic Test: Saliva Obtaining · Diagnostic Test: Serum obtaining

  • Experimental
    Stage III grade C Periodontitis

    Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.

    Diagnostic Test: GCF obtaining · Diagnostic Test: Saliva Obtaining · Diagnostic Test: Serum obtaining

Interventions

  • Diagnostic testGCF obtaining

    GCF obtaining: 2 GCF samples, 1 from the interproximal surface of 2 different teeth that bleeding on probing(-), were taken from each participant

  • Diagnostic testSaliva Obtaining

    Saliva obtaining: 1,5 ml unstimulated whole saliva collected from each participant

  • Diagnostic testSerum obtaining

    Serum obtaining : 8 ml of venous blood was collected from each participant and collecting blood centrifuged to obtain serum

06

What researchers measure

Primary outcomes

  1. Levels of Interleukin-38 (pg/ml) in GCF, saliva and serum fluid

    Time frame: 24 hours after taking the clinical measurements at the first visit

  2. Levels of Interleukin-36 gamma (pg/ml) in GCF, saliva and serum fluid

    Time frame: 24 hours after taking the clinical measurements at the first visit

Secondary outcomes

  1. Levels of Interleukin-17 (pg/ml) in GCF, saliva and serum fluid

    Time frame: 24 hours after taking the clinical measurements at the first visit

  2. Levels of Matrix Metalloproteinase-9 (ng/ml) in GCF, saliva and serum fluid

    Time frame: 24 hours after taking the clinical measurements at the first visit

07

Study locations

1 site
  • Akdeniz University Faculty of Dentistry
    Antalya, 07070, Turkey
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05435131
Lead sponsor
Akdeniz University
Responsible party
Hilal Korkmaz (Research Assistant, Akdeniz University) — Principal investigator
First posted
Jun 28, 2022
Start date
Jun 1, 2020
Primary completion
Jan 11, 2021
Completion
Jan 11, 2021
Last update
Jul 1, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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