Evaluation of Biomarkers Levels in Gingival Crevicular Fluid, Saliva and Serum for Different Periodontal Diseases
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
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2021
CompletedFirst Submitted
Initial submission to the registry
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
June 28, 2022
CompletedJuly 1, 2022
June 1, 2022
7 months
June 22, 2022
June 29, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Levels of Interleukin-38 (pg/ml) in GCF, saliva and serum fluid
24 hours after taking the clinical measurements at the first visit
Levels of Interleukin-36 gamma (pg/ml) in GCF, saliva and serum fluid
24 hours after taking the clinical measurements at the first visit
Secondary Outcomes (2)
Levels of Interleukin-17 (pg/ml) in GCF, saliva and serum fluid
24 hours after taking the clinical measurements at the first visit
Levels of Matrix Metalloproteinase-9 (ng/ml) in GCF, saliva and serum fluid
24 hours after taking the clinical measurements at the first visit
Study Arms (5)
Periodontal Health
EXPERIMENTALFull-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Gingivitis
EXPERIMENTALFull-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Stage II grade B Periodontitis
EXPERIMENTALFull-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Stage III grade B Periodontitis
EXPERIMENTALFull-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Stage III grade C Periodontitis
EXPERIMENTALFull-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Interventions
GCF obtaining: 2 GCF samples, 1 from the interproximal surface of 2 different teeth that bleeding on probing(-), were taken from each participant
Saliva obtaining: 1,5 ml unstimulated whole saliva collected from each participant
Serum obtaining : 8 ml of venous blood was collected from each participant and collecting blood centrifuged to obtain serum
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Akdeniz University Faculty of Dentistry
Antalya, 07070, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
June 22, 2022
First Posted
June 28, 2022
Study Start
June 1, 2020
Primary Completion
January 11, 2021
Study Completion
January 11, 2021
Last Updated
July 1, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF