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

NCT ID: NCT05435131

Last Updated: 2022-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-01-11

Brief Summary

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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.

Detailed Description

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Conditions

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Mouth Diseases Periodontal Inflammation Periodontal Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Periodontal Health

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

Group Type EXPERIMENTAL

GCF obtaining

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Serum obtaining

Intervention Type DIAGNOSTIC_TEST

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

Gingivitis

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

Group Type EXPERIMENTAL

GCF obtaining

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Serum obtaining

Intervention Type DIAGNOSTIC_TEST

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

Stage II grade B Periodontitis

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

Group Type EXPERIMENTAL

GCF obtaining

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Serum obtaining

Intervention Type DIAGNOSTIC_TEST

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

Stage III grade B Periodontitis

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

Group Type EXPERIMENTAL

GCF obtaining

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Serum obtaining

Intervention Type DIAGNOSTIC_TEST

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

Stage III grade C Periodontitis

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

Group Type EXPERIMENTAL

GCF obtaining

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Serum obtaining

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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GCF obtaining

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

Saliva Obtaining

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

Intervention Type DIAGNOSTIC_TEST

Serum obtaining

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Hilal Korkmaz

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Akdeniz University Faculty of Dentistry

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Hkorkmaz

Identifier Type: -

Identifier Source: org_study_id

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