Clinical trial NCT05435131: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mouth Diseases
Periodontal Inflammation
Periodontal Diseases
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Levels of Interleukin-38 (pg/ml) in GCF, saliva and serum fluid
timeFrame: 24 hours after taking the clinical measurements at the first visit
measure: Levels of Interleukin-36 gamma (pg/ml) in GCF, saliva and serum fluid
timeFrame: 24 hours after taking the clinical measurements at the first visit
Secondary outcomes:
measure: Levels of Interleukin-17 (pg/ml) in GCF, saliva and serum fluid
timeFrame: 24 hours after taking the clinical measurements at the first visit
measure: Levels of Matrix Metalloproteinase-9 (ng/ml) in GCF, saliva and serum fluid
timeFrame: 24 hours after taking the clinical measurements at the first visit
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Faculty of Dentistry
Study officials:
References: