Determination of the Levels of Lipocalin-2 and Semaphorin3A

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Periodontal Diseases; Gingivitis
• Intervention / Treatment: Procedure: Non-surgical Periodontal Treatment

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Cigli
    • Izmir, Cigli, Turkey, 35640
      • Izmir Katip Celebi University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Periodontally Healthy; 20 participants with bleeding on probing less than 10%, probing depths less than 4mm, and no clinical attachment loss which was measured by six sites per tooth
No Intervention: Gingivitis; 20 participants with bleeding on probing greater than 10%, probing depths less than 4mm, and no clinical attachment loss which was measured by six sites per tooth
Other: Periodontitis; 20 participants with bleeding on probing greater than or equal to 30%, probing depths greater than or equal to 5mm at least non-adjacent two teeth in each quadrant of the dentition, and clinical attachment loss greater than or equal to 4mm which was measured by six sites per tooth, and radiographic bone loss on the coronal third of root or severe (vertical/ horizontal) bone loss.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of Lipocalin-2	Investigating the concentrations of Lipocalin-2 level in gingival crevicular fluid in subjects with different periodontal diseases.	18 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Periodontal Disease, Non-surgical Periodontal Treatment, GCF
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Mouth Diseases; Gingival Diseases; Periodontitis; Gingivitis; Periodontal Diseases
• Other Study ID Numbers: 2019-TDU-DİSF-0009

Drug and device information, study documents

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