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

Primary Purpose

Mouth Diseases, Periodontal Inflammation, Periodontal Diseases

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

GCF obtaining

Saliva Obtaining

Serum obtaining

About this trial

This is an interventional diagnostic trial for Mouth Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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

Sites / Locations

Akdeniz University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Periodontal Health

Gingivitis

Stage II grade B Periodontitis

Stage III grade B Periodontitis

Stage III grade C Periodontitis

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT05435131

First Posted

June 22, 2022

Last Updated

June 29, 2022

Sponsor

Akdeniz University

1. Study Identification

Unique Protocol Identification Number

NCT05435131

Brief Title

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

Official Title

Evaluation of Interleukin (IL)-38, IL-36-gamma, IL-17 and Matrix Metalloproteinase-9 Levels in Gingival Crevicular Fluid, Saliva and Serum for Periodontal Health, Gingivitis and Periodontitis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

January 11, 2021 (Actual)

Study Completion Date

January 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mouth Diseases, Periodontal Inflammation, Periodontal Diseases

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) samples of GCF, saliva and serum were obtained from 90 systemically healthy non-smoker individuals with stage II grade B (P1, n=9), stage III grade B (P2, n=11) , stage III grade C (n=10), gingivitis (G, n=30) and healthy periodontium (S, n=30).

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Periodontal Health

Arm Type

Experimental

Arm Description

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

Arm Title

Gingivitis

Arm Type

Experimental

Arm Description

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

Arm Title

Stage II grade B Periodontitis

Arm Type

Experimental

Arm Description

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

Arm Title

Stage III grade B Periodontitis

Arm Type

Experimental

Arm Description

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

Arm Title

Stage III grade C Periodontitis

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

GCF obtaining

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Saliva Obtaining

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Serum obtaining

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

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 Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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

Facility Information:

Facility Name

Akdeniz University Faculty of Dentistry

City

Antalya

ZIP/Postal Code

07070

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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