Evaluation of Salivary Biomarker Levels of Individuals With Different Periodontal Diseases

Sponsor
Izmir Katip Celebi University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05774925
Collaborator
(none)
60
1
3
16.4
3.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: saliva obtaining
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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).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)
Primary Purpose:
Diagnostic
Official Title:
Assessment of Saliva Leucine Rich α-2 Glycoprotein1 (LRG1) And C Reactive Protein (CRP) Levels In Individuals With Different Periodontal Diseases
Actual Study Start Date :
Dec 8, 2021
Anticipated Primary Completion Date :
Mar 13, 2023
Anticipated Study Completion Date :
Apr 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Healthy Periodontium

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Diagnostic Test: saliva obtaining
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.

Experimental: Gingivitis

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Diagnostic Test: saliva obtaining
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.

Experimental: Periodontitis

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Diagnostic Test: saliva obtaining
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.

Outcome Measures

Primary Outcome Measures

  1. The total amount of LRG1 in saliva [24 hours after taking the clinical measurements at the first visit]

    The total amount of leucine rich α-2 glycoprotein1 in saliva

  2. The total amount of CRP in saliva [24 hours after taking the clinical measurements at the first visit]

    The total amount of C-reactive protein in saliva

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Izmir Katip Çelebi University Department of Periodontology İzmir Çiğli Turkey 35640

Sponsors and Collaborators

  • Izmir Katip Celebi University

Investigators

  • Study Director: Mehmet Sağlam, Izmir Katip Çelebi University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ece Ozer, Research Assistant, Izmir Katip Celebi University
ClinicalTrials.gov Identifier:
NCT05774925
Other Study ID Numbers:
  • 2021-TDU-DİŞF-0016
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 23, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2023