Comparison of Saliva Biomarkers in Two Different Geographical Regions of Turkey

Karabuk University

Status: Completed

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

Treatments: Diagnostic Test: Saliva Collection (Baseline); Procedure: Non-Surgical Intervention; Other: Probing; Diagnostic Test: Saliva Collection (After treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT06809439

TSA-2022-2551 (Other Grant/Funding Number)

ApprovalNo:11/04, 09.05.2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

77 participants in 4 patient groups

Control Ankara

Experimental group

Description:

Healthy group at Ankara University. Total smokers and non-smokers with clinically healthy gingiva, no deep gingival pockets (≤3mm) and no attachment loss, no bleeding on probing or \<10%, no radiographic bone loss were included in the study. Clinical parameters were recorded and saliva was collected in this group.

Treatment:

Other: Probing

Diagnostic Test: Saliva Collection (Baseline)

Control Atatürk

Experimental group

Description:

Healthy group at Atatürk University. A total of patients with clinically healthy gums, no deep gingival pockets (≤3 mm) and attachment loss, no bleeding on probing or \<10%, no radiographic bone loss, smokers and non-smokers were included in the study. Clinical parameters were recorded and saliva was collected in this group.

Treatment:

Other: Probing

Diagnostic Test: Saliva Collection (Baseline)

Periodontitis Ankara

Experimental group

Description:

Smoker patient who applied to Ankara University, Faculty of Dentistry, Department of Periodontics, diagnosed with Stage III periodontitis with a clinically probed pocket depth of more than 5 mm and radiographically ≥3 mm bone loss, smoker patient diagnosed with Stage III.In this group, baseline and post-treatment clinical parameters were recorded and saliva was collected.

Treatment:

Diagnostic Test: Saliva Collection (After treatment)

Other: Probing

Procedure: Non-Surgical Intervention

Diagnostic Test: Saliva Collection (Baseline)

Periodontitis Atatürk

Experimental group

Description:

Twenty-two patients who applied to the Department of Periodontics, Faculty of Dentistry, Ataturk University, and were diagnosed with Stage III Grade A periodontitis, 11 smokers and 11 smokers, with clinically probed pocket depths greater than 5 mm and radiographically ≥3 mm bone loss.

Treatment:

Diagnostic Test: Saliva Collection (After treatment)

Other: Probing

Procedure: Non-Surgical Intervention

Diagnostic Test: Saliva Collection (Baseline)