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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Giresun, Turkey
    • Zeynep Pinar Keles Yucel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 49 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels	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.	one day after the clinical periodontal measurements

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Principal Investigator: Zeynep Pinar Keles Yucel, Giresun University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: 2017/009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No