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OpenTrials
Completed

NCT Number: NCT04407026

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

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.

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Key information

Age range

25 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zeynep Pinar Keles Yucel

Giresun, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biofluids

Biological

Gingival crevicular fluid, saliva and serum samples were obtained.

Primary outcomes

  1. Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels

    Time frame: one day after the clinical periodontal measurements

    Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels of gingivitis and periodontitis patients as well as healthy individuals were analyzed to identify the potential role of these peptides in periodontal diseases.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

Two Novel Peptides Associated With Stage 3 Periodontitis: TFF-1 and TFF-3

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 29, 2020
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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