Evaluation of Salivary Gal-7, Gal-10 and MMP-9 Levels of Individuals With Different Periodontal Diseases

Assessment of Saliva Galectin-7, Galectin-10 and MMP-9 Levels In Individuals With Different Periodontal Diseases

The aim of this study is; detection of Galectin-10, Galectin-7, MMP-9 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 Galectin-10, Galectin-7 and MMP-9 levels in the biological samples.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases
• Intervention / Treatment: Diagnostic test: Saliva obtaining

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ceren Köksal, Research assistant; Phone Number: +905356807469; Email: ceren2292@gmail.com

Study Locations

• Turkey
  • Çiğli
    • İzmir, Çiğli, Turkey, 35640
      • Recruiting
      • Izmir Katip Çelebi University Department of Periodontology
      • Contact: Ceren Köksal; Phone Number: +905356807469; Email: ceren2292@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total amount of Gal-10 in saliva	The total amount of Galectin-10 in saliva	24 hours after taking the clinical measurements at the first visit
The total amount of Gal-7 in saliva	The total amount of Galectin-7 in saliva	24 hours after taking the clinical measurements at the first visit
The total amount of MMP-9 in saliva	The total amount of Matrix metalloproteinase 9 in saliva	24 hours after taking the clinical measurements at the first visit

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University
• Investigators: Study Director: Mehmet Sağlam, İzmir Katip Çelebi University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): March 24, 2025

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases
• Other Study ID Numbers: 2023-TDU-DİŞF-0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No