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Evaluation of Salivary Biomarker Levels of Individuals With Different Periodontal Diseases

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
saliva obtaining
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periodontal Diseases

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.) At least twenty permanent teeth in the mouth Non-smoker No medication for continuous use Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months. Not in pregnancy or lactation period. For the periodontitis group that has not received periodontal treatment in the last 6 months For the periodontitis group; According to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss For the gingivitis group; According to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss For healthy group; According to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study. Exclusion Criteria: Any oral or systemic disease Regularly using a systemic medication During pregnancy or lactation Received periodontal treatment within the last 6 months. Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months Smokers are not included in the study

Sites / Locations

  • Izmir Katip Çelebi University Department of Periodontology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy Periodontium

Gingivitis

Periodontitis

Arm Description

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Outcomes

Primary Outcome Measures

The total amount of LRG1 in saliva
The total amount of leucine rich α-2 glycoprotein1 in saliva
The total amount of CRP in saliva
The total amount of C-reactive protein in saliva

Secondary Outcome Measures

Full Information

First Posted
March 7, 2023
Last Updated
April 12, 2023
Sponsor
Izmir Katip Celebi University
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1. Study Identification

Unique Protocol Identification Number
NCT05774925
Brief Title
Evaluation of Salivary Biomarker Levels of Individuals With Different Periodontal Diseases
Official Title
Assessment of Saliva Leucine Rich α-2 Glycoprotein1 (LRG1) And C Reactive Protein (CRP) Levels In Individuals With Different Periodontal Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
March 20, 2023 (Actual)
Study Completion Date
April 10, 2023 (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
No

5. Study Description

Brief Summary
The aim of this study is; detection of leucine rich α-2 glycoprotein1 (LRG1), c-reactive protein (CRP) levels in saliva samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. Materials and methods: Samples of saliva were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20). Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine LRG and CRP levels in the biological samples.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) samples of saliva were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Periodontium
Arm Type
Experimental
Arm Description
Full-mouth clinical periodontal measurements recorded and saliva obtained.
Arm Title
Gingivitis
Arm Type
Experimental
Arm Description
Full-mouth clinical periodontal measurements recorded and saliva obtained.
Arm Title
Periodontitis
Arm Type
Experimental
Arm Description
Full-mouth clinical periodontal measurements recorded and saliva obtained.
Intervention Type
Diagnostic Test
Intervention Name(s)
saliva obtaining
Intervention Description
The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Tubes were stored at -80ºC until the day of analysis.
Primary Outcome Measure Information:
Title
The total amount of LRG1 in saliva
Description
The total amount of leucine rich α-2 glycoprotein1 in saliva
Time Frame
24 hours after taking the clinical measurements at the first visit
Title
The total amount of CRP in saliva
Description
The total amount of C-reactive protein in saliva
Time Frame
24 hours after taking the clinical measurements at the first visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.) At least twenty permanent teeth in the mouth Non-smoker No medication for continuous use Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months. Not in pregnancy or lactation period. For the periodontitis group that has not received periodontal treatment in the last 6 months For the periodontitis group; According to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss For the gingivitis group; According to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss For healthy group; According to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study. Exclusion Criteria: Any oral or systemic disease Regularly using a systemic medication During pregnancy or lactation Received periodontal treatment within the last 6 months. Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months Smokers are not included in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Sağlam
Organizational Affiliation
Izmir Katip Çelebi University
Official's Role
Study Director
Facility Information:
Facility Name
Izmir Katip Çelebi University Department of Periodontology
City
İzmir
State/Province
Çiğli
ZIP/Postal Code
35640
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Evaluation of Salivary Biomarker Levels of Individuals With Different Periodontal Diseases

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