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NCT Number: NCT04390997

Determination of the Levels of Lipocalin-2 and Semaphorin3A

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Celebi University, Faculty of Dentistry

Izmir, Cigli, 35640, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-surgical periodontal treatment

Procedure

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

Primary outcomes

  1. The level of Lipocalin-2

    Time frame: 18 months

    Investigating the concentrations of Lipocalin-2 level in gingival crevicular fluid in subjects with different periodontal diseases.

  2. The level of Semaphorin 3A

    Time frame: 18 months

    Investigating the concentrations of Semaphorin 3A leves in gingival crevicular fluid in subjects with different periodontal diseases.

Secondary outcomes

  1. Effects of non-surgical periodontal treatment on the levels of Lipocalin-2 and Semaphorin3A

    Time frame: 18 months

    Analyzing the correlation of Lipocalin-2 and Semaphorin3A with clinical parameters at the first and third months after the nonsurgical periodontal treatment

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 18, 2020
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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