Evaluation of Salivary Biomarker Levels of Individuals With Different Periodontal Diseases

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

saliva obtaining

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

Arm Label

Healthy Periodontium

Gingivitis

Periodontitis

Arm Description

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

NCT ID

NCT05774925

First Posted

March 7, 2023

Last Updated

April 12, 2023

Sponsor

Izmir Katip Celebi University

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

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

Periodontal Diseases

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial