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

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ClinicalTrials.gov Identifier: NCT04407026
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Zeynep Pinar KELES YUCEL, Giresun University

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
Periodontal Diseases 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.

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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 : July 1, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : April 1, 2018

Group/Cohort 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.




Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Gingival crevicular fluid, saliva and serum


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Ages Eligible for Study:   25 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Healthy controls included volunteers with clinically healthy periodontium who had BOP < 10% and PD ≤ 3 mm, no sites with attachment loss or radiographic sign of alveolar bone destruction. Gingivitis patients showed PD ≤ 3 mm with BOP > 50% in the entire mouth as well as no clinical attachment loss or alveolar bone loss. Periodontitis patients (Stage 3) had PD ≥ 6 mm, interdental CAL ≥ 5 mm affecting 30% of the teeth or more and showed radiographic bone loss. They showed also no more than 4 teeth loss due to periodontitis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407026


Locations
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Turkey
Zeynep Pinar Keles Yucel
Giresun, Turkey
Sponsors and Collaborators
Aydin Adnan Menderes University
Investigators
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Principal Investigator: Zeynep Pinar Keles Yucel Giresun University
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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    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases