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

NCT04407026 | Completed

• 1 other identifier: 2017/009
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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

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

Interventions

biofluids BIOLOGICAL

Gingival crevicular fluid, saliva and serum samples were obtained.

Gingivitis; Healthy; Stage 3 periodontitis

Eligibility Criteria

• Age: 25 Years - 49 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Zeynep Pinar Keles Yucel

Giresun, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid, saliva and serum

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Zeynep Pinar Keles Yucel

  Giresun University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: May 29, 2020
• Study Start: July 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)