Evaluation of Salivary Galectin-8, Galectin-9 and RANKL Levels of Individuals With Different Periodontal Diseases

Periodontal Diseases Clinical Trial

Official title:

Assessment of Saliva Galectin-8, Galectin-9 and RANKL Levels in Individuals With Different Periodontal Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06404476
• Other study ID #: 2023-TDR-SABE-0013
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2024
• Est. completion date: June 24, 2025

Study information

• Verified date: May 2024
• Source: Izmir Katip Celebi University
• Contact: Kübra Aydin
• Phone: +905365805175
• Email: kubra.aydin.er[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is; detection of Galectin-8, Galectin-9 and RANKL 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-8, Galectin-9 and RANKL levels in the biological samples.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 24, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Diagnostic Test:
• saliva obtaining
The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. In 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.

Locations

Country	Name	City	State
Turkey	Izmir Katip Çelebi University	Izmir	Çigli

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total amount of Galectin-8 in saliva	The total amount of Galectin-8 in saliva	24 hours after taking the clinical measurements at the first visit
Primary	The total amount of Galectin-9 in saliva	The total amount of Galectin-9 in saliva	24 hours after taking the clinical measurements at the first visit
Primary	The total amount of RANKL in saliva	The total amount of Receptor activator of nuclear factor kappaB ligand (RANKL) in saliva	24 hours after taking the clinical measurements at the first visit