Clinical trial NCT06809439: Comparison of Saliva Biomarkers in Two Different Geographical Regions of Turkey
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Saliva
Cortisol
Smoking, Tobacco
Periodontal Bone Loss
Periodontal Disease
Periodontal Therapy
Keywords: RANKL
osteoprotegerin
interleukin-10
non-surgical periodontal therapy
periodontitis
saliva
enviromental
geographical locations
Lead sponsor: Karabuk University
Sponsor class: OTHER
Collaborators: name: Ataturk University
name: Ankara University
First posted: 2025-02-05
Enrollment: 77
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 77 subjects in Ankara and Erzurum, 19 non-smokers (NS-P) with stage III, grade B generalized periodontitis and 14 smokers (SP) with stage III, grade C generalized periodontitis, as well as 22 non-smokers (NS-C) and 22 smokers (SC) periodontally healthy control cases were included in the study.Periodontal parameters were recorded, and unstimulated saliva samples were collected from all patients. Periodontitis patients (N=33) were evaluated clinically and biochemically (saliva IL-1β, cortisol, RANKL, OPG, and IL-10) 4 weeks after complete oral cleansing and root correction (SRP). Saliva samples were analyzed using enzyme-linked immunosorbent assay (ELISA). The data were analyzed using the SPSS software version 22.0.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Study population, pre-treatment and post-treatment periodontal clinical parameters
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Salivary biomarkers
timeFrame: up to 2 months
Other outcomes:
measure: Determination of Pocket Depth (PD)
timeFrame: up to 4 weeks
measure: Determination of Clinical Attachment Level (CAL)
timeFrame: up to 4 weeks
measure: Determination of the Presence and Accumulation Level of Dental Plaque
timeFrame: up to 4 weeks
measure: Determination of Gingival Bleeding on Probing
timeFrame: up to 4 weeks
measure: RANKL Measurement
timeFrame: up to 2 months
measure: OPG Measurement
timeFrame: up to 2 months
measure: IL-10 Measurement
timeFrame: up to 2 months
measure: IL-1β Analysis
timeFrame: up to 2 months
measure: Cortisol Analysis
timeFrame: up to 2 months
Locations:
city: Ankara
country: Turkey
facility: AnkaraUniversity
city: Karabük
country: Turkey
facility: Karabuk University
Study officials:
References:
citation: Mengel R, Bacher M, Flores-De-Jacoby L. Interactions between stress, interleukin-1beta, interleukin-6 and cortisol in periodontally diseased patients. J Clin Periodontol. 2002 Nov;29(11):1012-22. doi: 10.1034/j.1600-051x.2002.291106.x.