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

Sponsor
Aydin Adnan Menderes University (Other)
Overall Status
Completed
CT.gov ID
NCT04407026
Collaborator
(none)
100
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9
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: biofluids

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Two Novel Peptides Associated With Stage 3 Periodontitis: TFF-1 and TFF-3
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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.

Biological: biofluids
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.

Biological: biofluids
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.

Biological: biofluids
Gingival crevicular fluid, saliva and serum samples were obtained.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 49 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zeynep Pinar Keles Yucel Giresun Turkey

Sponsors and Collaborators

  • Aydin Adnan Menderes University

Investigators

  • Principal Investigator: Zeynep Pinar Keles Yucel, Giresun University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeynep Pinar KELES YUCEL, Assistant Prof., Giresun University
ClinicalTrials.gov Identifier:
NCT04407026
Other Study ID Numbers:
  • 2017/009
First Posted:
May 29, 2020
Last Update Posted:
May 29, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 29, 2020