Gingival Crevicular Fluid and Salivary Levels of GDF-15, Smad2, Smad5, Smad6, and IL-6 in Patients With Periodontitis

NCT ID: NCT07201142

Last Updated: 2025-10-01

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

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-03

Study Completion Date

2024-12-17

Brief Summary

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The dysregulation of the transforming growth factor-beta signaling pathway can lead to inflammation and tissue destruction in the pathogenesis of periodontitis. This study aims to evaluate the levels of GDF-15, Smad 2, Smad 5, Smad 6, and IL-6 in gingival crevicular fluid (GCF) and saliva between individuals with periodontitis and periodontal healthy controls and to evaluate the relationship of these biomarkers with clinical periodontal parameters. This study aims to investigate the levels of GDF-15, Smad2, Smad5, Smad6, and IL-6 in GCF and saliva samples from individuals with periodontitis and periodontally healthy controls, as well as to assess the associations of these biomarkers with clinical periodontal parameters. A total of 44 systemically healthy individuals, including 22 patients diagnosed with stage III/grade B periodontitis and 22 periodontal healthy individuals, were included in the study. Clinical periodontal parameters (plaque index (PI), probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP)) were recorded. GDF-15, Smad 2, Smad 5, Smad 6, and IL-6 levels in saliva and GCF were analyzed using the ELISA method.

Detailed Description

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Conditions

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Periodontitis Periodontal Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Periodontitis

No interventions assigned to this group

Control

Periodontally Healthy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* being over 18 years of age;
* having at least 20 natural teeth excluding third molars;
* being systemically healthy

Exclusion Criteria

* under 18 years of age;
* had used antibiotics
* had used nonsteroidal anti-inflammatory drugs, corticosteroids, immunosuppressants, beta-blockers, calcium channel blockers, anticoagulants, or hormonal contraceptives within the past 6 months;
* had systemic diseases such as diabetes mellitus, rheumatoid arthritis, cardiovascular diseases, epilepsy, renal or hepatic disorders, or viral infections like HIV/AIDS;
* pregnant or breastfeeding;
* current smokers or had a history of alcoholism;
* had received nonsurgical periodontal therapy within the last 6 months or surgical periodontal treatment within the last 12 months;
* had fewer than 20 natural teeth (excluding third molars);
* had fixed orthodontic appliances.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medipol University

OTHER

Sponsor Role collaborator

Melis Yilmaz

OTHER

Sponsor Role lead

Responsible Party

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Melis Yilmaz

Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Medipol University

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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1097/22.12.2022

Identifier Type: -

Identifier Source: org_study_id

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