Comparison of Saliva Biomarkers in Two Different Geographical Regions of Turkey

Not Applicable

Completed

• Conditions: Saliva; Cortisol; Smoking, Tobacco; Periodontal Bone Loss; Periodontal Disease; Periodontal Therapy

• Registration Number: NCT06809439
• Lead Sponsor: Karabuk University

Brief 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.

Study Timeline

• Study Start: 2023-01-02
• Primary Completion: 2023-05-08
• Study Completion: 2023-07-03
• Status Verified: 2024-09
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• 35-60 years of age
• good cooperation
• a minimum of 20 permanent teeth, excluding third molars

Exclusion Criteria

• systemic diseases
• taking any medications
• received antibiotic treatment in the last three months
• those who had undergone periodontal treatment six months ago
• pregnant or breastfeeding patients
• prosthetic restorations
• undergoing orthodontic treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Study population, pre-treatment and post-treatment periodontal clinical parameters	up to 4 weeks	This study included 10 systemically healthy non-smokers from Ankara with stage III, grade B generalized periodontitis, 8 smokers with stage III, grade C generalized periodontitis, 11 periodontally healthy non-smokers, and 11 periodontally healthy smokers. In Erzurum, systemically healthy, 9 non-smokers, stage III B generalized periodontitis , 6 smokers (≥10/day), stage III C generalized periodontitis, 11 periodontally healthy non-smokers, and 11 periodontally healthy smokers were included. Clinical parameters of probing depth (PPD), clinical attachment level (CAL), plaque index (PI), and bleeding on probing (BOP) were recorded . All clinical measurements were made after saliva samples were taken and recorded as initial values. The periodontal index form was used for this purpose. (https://www.periodontalchart-online.com/uk/) Nonsurgical periodontal treatments lasted 4 weeks. Baseline and post-treatment periodontal parameters were compared.

Secondary Outcome Measures

Name	Time	Method
Salivary biomarkers	up to 2 months	Saliva IL-1β (pg/ml), cortisol (ng/ml), RANKL (pg/ml), OPG(ng/ml), and IL-10 (pg/ml) concentrations were assessed via ELISA. The baseline saliva of the control groups and the pre- and post-treatment salivary biochemical parameters of the treatment groups were similar in both cities evaluated.

Trial Locations

Locations (2)

AnkaraUniversity; 🇹🇷 Ankara, Turkey

Karabuk University; 🇹🇷 Karabük, Turkey