Evaluation of Salivary Adseverin, 1-Alpha Defensin and sRANKL Levels of Individuals With Different Periodontal Diseases

NCT06402877 | Completed

• 1 other identifier: 2024-TDU-DİŞF-0015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

: The aim of this study is; detection of Adseverin,1-alpha Defensin,sRANKL(soluble 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 Adseverin,1-alpha Defensin,sRANKL(soluble RANKL) levels in the biological samples.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (3)

• The total amount of Adseverin in saliva

  The total amount of Adseverin in saliva

  24 hours after taking the clinical measurements at the first visit]

• The total amount of 1-Alpha Defensin in saliva

  The total amount of 1-Alpha Defensin in saliva

  24 hours after taking the clinical measurements at the first visit

• The total amount of sRANKL in saliva

  The total amount of soluble RANKL in saliva

  24 hours after taking the clinical measurements at the first visit

Study Arms (3)

Healthy Periodontium

EXPERIMENTAL

Full-mouth clinical periodontal measurements recorded and saliva obtain

Diagnostic Test: Saliva obtaining

Periodontitis

EXPERIMENTAL

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Diagnostic Test: Saliva obtaining

Gingivitis

EXPERIMENTAL

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Diagnostic Test: Saliva obtaining

Interventions

Saliva obtaining DIAGNOSTIC_TEST

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.

Gingivitis; Healthy Periodontium; Periodontitis

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Çelebi University Department of Periodontology

Izmir, Çiğli, 35640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ayşe Efe

  Izmir Katip Çelebi University Department of Periodontology İzmir, Çiğli, Turkey, 35640

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant at Periodontology

Model Details: 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).

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: April 26, 2024
• Primary Completion: February 25, 2025
• Study Completion: November 24, 2025
• Last Updated: December 9, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)