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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04407026
• Other study ID #: 2017/009
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: May 2020
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 1, 2018
• Est. primary completion date: March 1, 2018
• Gender: All
• Age group: 25 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

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

Locations

Country	Name	City	State
Turkey	Zeynep Pinar Keles Yucel	Giresun

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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