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Determination of the Levels of Lipocalin-2 and Semaphorin3A

Primary Purpose

Gingivitis, Periodontitis, Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Non-surgical Periodontal Treatment
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gingivitis focused on measuring Periodontal Disease, Non-surgical Periodontal Treatment, GCF

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Izmir Katip Celebi University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Other

Arm Label

Periodontally Healthy

Gingivitis

Periodontitis

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

The level of Lipocalin-2
Investigating the concentrations of Lipocalin-2 level in gingival crevicular fluid in subjects with different periodontal diseases.
The level of Semaphorin 3A
Investigating the concentrations of Semaphorin 3A leves in gingival crevicular fluid in subjects with different periodontal diseases.

Secondary Outcome Measures

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

Full Information

First Posted
May 13, 2020
Last Updated
February 9, 2021
Sponsor
Izmir Katip Celebi University
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1. Study Identification

Unique Protocol Identification Number
NCT04390997
Brief Title
Determination of the Levels of Lipocalin-2 and Semaphorin3A
Official Title
Determination of the Levels of Lipocalin-2 and Semaphorin3A in Gingival Crevicular Fluid in Subjects With Different Periodontal Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Periodontitis, Periodontal Diseases
Keywords
Periodontal Disease, Non-surgical Periodontal Treatment, GCF

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periodontally Healthy
Arm Type
No Intervention
Arm Description
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
Arm Title
Gingivitis
Arm Type
No Intervention
Arm Description
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
Arm Title
Periodontitis
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-surgical Periodontal Treatment
Intervention Description
Non-surgical periodontal treatment includes scaling and root planning by using curettes and ultrasonic devices only in the periodontitis group.
Primary Outcome Measure Information:
Title
The level of Lipocalin-2
Description
Investigating the concentrations of Lipocalin-2 level in gingival crevicular fluid in subjects with different periodontal diseases.
Time Frame
18 months
Title
The level of Semaphorin 3A
Description
Investigating the concentrations of Semaphorin 3A leves in gingival crevicular fluid in subjects with different periodontal diseases.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Effects of non-surgical periodontal treatment on the levels of Lipocalin-2 and Semaphorin3A
Description
Analyzing the correlation of Lipocalin-2 and Semaphorin3A with clinical parameters at the first and third months after the nonsurgical periodontal treatment
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Izmir Katip Celebi University, Faculty of Dentistry
City
Izmir
State/Province
Cigli
ZIP/Postal Code
35640
Country
Turkey

12. IPD Sharing Statement

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Determination of the Levels of Lipocalin-2 and Semaphorin3A

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