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Oral and Systemic Levels of TFF-1 and TTF-3 in Periodontal Diseases

NCT ID: NCT04407026

Last Updated: 2020-05-29

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-04-01

Brief Summary

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Trefoil factor family (TFF) consists of a group of small peptides that have key roles in host immune response and repair of tissue damage. Interleukin (IL)-1β is a regulatory proinflammatory cytokine in periodontal inflammation. This study aimed to investigate the levels of TFF-1, TFF-3 and IL-1β in gingival crevicular fluid (GCF), saliva and serum of patients with gingivitis, stage 3 periodontitis and healthy individuals.

Detailed Description

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A total of one hundred participants were enrolled for the study. All individuals were assessed clinically and radiographically. Full-mouth clinical periodontal examinations were performed by the measurements of probing depth (PD), clinical attachment level (CAL), gingival index (GI), plaque index (PI) and bleeding on probing (BOP). All these measurements were recorded at six sites around each tooth with a manual periodontal probe. The participants were categorized into three groups: healthy controls (n=25), patients with gingivitis (n=25) and patients with periodontitis (n=50). Gingival crevicular fluid, saliva and serum samples were collected from each participant one day after the clinical periodontal measurements. TFF-1, TFF-3 and IL-1β levels of these biofluids were determined using the enzyme-linked immunosorbent assay.

Conditions

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Periodontal Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy

Healthy control group (n=25) consisted of the volunteers having clinically healthy gingiva, PD≤3 mm, BOP\<10% and no sign of clinical attachment loss and radiographic alveolar bone destruction.

biofluids

Intervention Type BIOLOGICAL

Gingival crevicular fluid, saliva and serum samples were obtained.

Gingivitis

Gingivitis group (n=25) had PD≤3 mm with BOP\>50% in the entire mouth, and no clinical attachment loss or alveolar bone loss.

biofluids

Intervention Type BIOLOGICAL

Gingival crevicular fluid, saliva and serum samples were obtained.

Stage 3 periodontitis

Stage 3 periodontitis group included the patients exhibiting PD ≥6 mm and interdental CAL ≥5 mm at %30 or more teeth. They had no more than four teeth loss.

biofluids

Intervention Type BIOLOGICAL

Gingival crevicular fluid, saliva and serum samples were obtained.

Interventions

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biofluids

Gingival crevicular fluid, saliva and serum samples were obtained.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Systemically healthy individuals
* No history of smoking
* Individuals between the ages of 25-50 years
* Having at least 20 natural teeth

Exclusion Criteria

* Any systemic disorders (i.e. diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological disorders, collagen-metabolic diseases, cancer)
* A history of smoking
* Pregnancy or lactation
* A history of surgical/non-surgical periodontal therapy in the past 1 year
* Drug therapy (e.g. anti-inflammatory, antibiotic treatment or any other pharmacological treatment) in the previous 6 months
Minimum Eligible Age

25 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Pinar KELES YUCEL

Assistant Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeynep Pinar Keles Yucel

Role: PRINCIPAL_INVESTIGATOR

Giresun University

Locations

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Zeynep Pinar Keles Yucel

Giresun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2017/009

Identifier Type: -

Identifier Source: org_study_id