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Completed

NCT Number: NCT06402877

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

: 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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Çelebi University Department of Periodontology

Izmir, Çiğli, 35640, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The total amount of Adseverin in saliva

    Time frame: 24 hours after taking the clinical measurements at the first visit]

    The total amount of Adseverin in saliva

  2. The total amount of 1-Alpha Defensin in saliva

    Time frame: 24 hours after taking the clinical measurements at the first visit

    The total amount of 1-Alpha Defensin in saliva

  3. The total amount of sRANKL in saliva

    Time frame: 24 hours after taking the clinical measurements at the first visit

    The total amount of soluble RANKL in saliva

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

Assessment of Saliva Adseverin,1-Alpha Defensin and sRANKL (Soluble RANKL) Levels In Individuals With Different Periodontal Diseases

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 7, 2024
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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