Determination of the Levels of Lipocalin-2 and Semaphorin3A

Periodontitis Clinical Trial

Official title:

Determination of the Levels of Lipocalin-2 and Semaphorin3A in Gingival Crevicular Fluid in Subjects With Different Periodontal Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04390997
• Other study ID #: 2019-TDU-DISF-0009
• Status: Completed
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: January 15, 2021

Study information

• Verified date: February 2021
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this clinical trial is to investigate the concentrations of Lipocalin-2 and Semaphorin 3A levels in gingival crevicular fluid in subjects with different periodontal diseases. At the same time for the periodontitis group; the purpose of this study is to analyze the correlation of these proteins with clinical parameters at the first and third months after the nonsurgical periodontal treatment.

Description:

In our study, gingival crevicular fluid samples will be taken along with the measurement of all oral clinical parameters from sixty systemically healthy volunteers (20 periodontally healthy, 20 gingivitis, and 20 periodontitis). Gingival crevicular fluid samples will be taken again after the nonsurgical periodontal treatment for the periodontitis group in the first and third months. Lipocalin-2 and Semaphorin 3A levels will be determined by an enzyme-linked immunosorbent assay test (ELISA). Subsequent statistical analyses will be used to interpret protein levels among different groups and peridontitis group after the nonsurgical periodontal treatment.

Possible significant differences may illuminate the future work with Lipocalin-2 and Semaphorin 3A. Also, these glycoproteins may help to develop different diagnostic methods or treatment strategies for future periodontal treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 15, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Being systemically healthy

• Having at least 20 teeth in the dentition, excluding third molars

• Not using alcohol nor smoking

• Not using medications

• Not taking any antibiotics, anti-inflammatory, nor systemic corticosteroid drugs in the last six months

• Not being in the lactation period nor pregnancy

Exclusion Criteria:

• Having any oral or systemic diseases

• Using alcohol or smoking

• Using medications

• Taking any antibiotics, anti-inflammatory, or systemic corticosteroid drugs in the last six months

• Being in the lactation period or pregnancy

• Being treated with periodontal treatment in the last six months

Related Conditions & MeSH terms

• Gingivitis
• Periodontal Diseases
• Periodontitis

Intervention

Procedure:
• Non-surgical Periodontal Treatment
Non-surgical periodontal treatment includes scaling and root planning by using curettes and ultrasonic devices only in the periodontitis group.

Locations

Country	Name	City	State
Turkey	Izmir Katip Celebi University, Faculty of Dentistry	Izmir	Cigli

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of Lipocalin-2	Investigating the concentrations of Lipocalin-2 level in gingival crevicular fluid in subjects with different periodontal diseases.	18 months
Primary	The level of Semaphorin 3A	Investigating the concentrations of Semaphorin 3A leves in gingival crevicular fluid in subjects with different periodontal diseases.	18 months
Secondary	Effects of non-surgical periodontal treatment on the levels of Lipocalin-2 and Semaphorin3A	Analyzing the correlation of Lipocalin-2 and Semaphorin3A with clinical parameters at the first and third months after the nonsurgical periodontal treatment	18 months