NCT06809439

Comparison of Saliva Biomarkers in Two Different Geographical Regions of Turkey

Comparison of Salivary RANKL, OPG, IL-10, IL-1β and Cortisol Levels With Non-surgical Periodontal Treatment in Periodontitis Patients Living in Two Different Geographical Regions in Turkey

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Karabuk University · Academic / Other
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Periodontitis is a multifactorial, chronic inflammatory disease caused by many factors such as pathogenic microorganisms, host response, environmental and systemic factors. Immune mechanisms triggered by host-bacteria interaction can initiate tissue destruction by leading to the release of large amounts of inflammatory mediators such as IL-1β. It is thought that IL-10 has a regulatory role by limiting the initiation and progression of the acute inflammatory response with its anti-inflammatory effect. The high detection of RANKL and RANKL/OPG ratios in periodontitis indicates that these markers play a role in bone destruction. Elucidating the connections between the immune system and bone-related cytokines will contribute significantly to the resolution of these complex mechanisms underlying periodontal diseases. Risk factors for periodontal diseases include gender, age, smoking and some hereditary factors. Cortisol is an important marker of psychological stress. It is emphasized that stress and depression reduce immune system function and cause chronic inflammation. Thus, it indirectly provokes periodontal tissue destruction.

Detailed description

This study consists of patients and healthy volunteers. Saliva will be collected only once from healthy volunteers; from patients at the beginning and after non-surgical periodontal treatments are performed by the researchers. In the collected saliva; clinical parameters and salivary RANKL, OPG, IL-10, IL-1β, cortisol levels will be determined in periodontitis and periodontally healthy individuals living in two different geographical regions in Turkey (Ankara -Erzurum); it will be determined whether non-surgical periodontal treatment has an effect on cytokines determined in saliva and clinical status at the end of 1-month follow-up period; periodontal pathogenesis and host response will be evaluated in smoker and non-smoker groups. Analyses will be performed by ELISA method. The study is based on the hypothesis that "different regional and geographical conditions determining climate, culture, environment, life, stress situations affect the course of periodontitis disease and host response". A regional comparison will be made between markers that affect the course of periodontitis disease and play a role in its pathogenesis in patients with different climate, living and cultural conditions, according to location.

Conditions

• Saliva
• Cortisol
• Smoking, Tobacco
• Periodontal Bone Loss
• Periodontal Disease
• Periodontal Therapy

Interventions

Type	Name	Description
PROCEDURE	Non-Surgical Intervention	Oral hygiene instructions including tooth brushing, flossing, and interdental brushing were given to all patient groups before non-surgical periodontal treatment. In both periodontitis groups, scaling, and root surface smoothing were performed using ultrasonic instruments (Woodpecker Medicals Ins. Co., USA) and Gracey Curettes (Hu-Friedy, Chicago, IL, USA) under local anesthesia once a week for 4 weeks.
DIAGNOSTIC_TEST	Saliva Collection (Baseline)	Unstimulated saliva samples were collected from all participants between 9:00 and 11:00 am. Clinical periodontal measurements were performed after saliva collection to prevent contamination (bleeding, etc.). Participants refrained from brushing their teeth the morning before sampling and from eating, drinking, or smoking for at least 2 hours before sampling. Patients were asked to rinse their mouths with distilled water 5 minutes before saliva collection. A saliva sample was then collected by spitting directly into a sterile tube. Sample collection was continued for 5 minutes.
OTHER	Probing	Clinical and radiographic evaluations were performed by trained and calibrated examiners at Ankara University (SY) and Ataturk University (OT). Clinical parameters of probing depth (PPD), clinical attachment level CAL, plaque index PI, and bleeding on probing (BOP) were recorded from six tooth regions (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, middle lingual, and disto-lingual) using periodontal probe. Bone loss was assessed using panoramic radiographs, confirming the diagnosis of periodontitis.
DIAGNOSTIC_TEST	Saliva Collection (After treatment)	Unstimulated saliva samples were collected from all participants between 9:00 and 11:00 am. Clinical periodontal measurements were performed after saliva collection to prevent contamination (bleeding, etc.). Participants refrained from brushing their teeth the morning before sampling and from eating, drinking, or smoking for at least 2 hours before sampling. Patients were asked to rinse their mouths with distilled water 5 minutes before saliva collection. A saliva sample was then collected by spitting directly into a sterile tube. Sample collection was continued for 5 minutes.

Timeline

• Start date: 2023-01-02
• Primary completion: 2023-05-08
• Completion: 2023-07-03
• First posted: 2025-02-05
• Last updated: 2025-02-05

Locations

2 sites across 1 country: Turkey (Türkiye)