Determination of the Levels of Lipocalin-2 and Semaphorin3A

Study Overview
=================
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.

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

Conditions
-----------------
Gingivitis, Periodontitis, Periodontal Diseases

Intervention / Treatment
-----------------
* Procedure: Non-surgical Periodontal Treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Periodontally Healthy<br>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<br>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<br>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<br>* Non-surgical periodontal treatment includes scaling and root planning by using curettes and ultrasonic devices only in the periodontitis group.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periodontal Disease, Non-surgical Periodontal Treatment, GCF