Comparison of Saliva Biomarkers in Two Different Geographical Regions of Turkey

NCT06809439 | Completed

• 2 other identifiers: ApprovalNo:11/04, 09.05.2022TSA-2022-2551
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Study population, pre-treatment and post-treatment periodontal clinical parameters

  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.

  up to 4 weeks

Secondary Outcomes (1)

• Salivary biomarkers

  up to 2 months

Other Outcomes (9)

• Determination of Pocket Depth (PD)

  up to 4 weeks

• Determination of Clinical Attachment Level (CAL)

  up to 4 weeks

• Determination of the Presence and Accumulation Level of Dental Plaque

  up to 4 weeks

Study Arms (4)

Control Ankara

EXPERIMENTAL

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.

Diagnostic Test: Saliva Collection (Baseline); Other: Probing

Control Atatürk

EXPERIMENTAL

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.

Diagnostic Test: Saliva Collection (Baseline); Other: Probing

Periodontitis Ankara

EXPERIMENTAL

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.

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

Periodontitis Atatürk

EXPERIMENTAL

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.

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

Interventions

Non-Surgical Intervention PROCEDURE

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.

Periodontitis Ankara; Periodontitis Atatürk

Saliva Collection (Baseline) DIAGNOSTIC_TEST

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.

Control Ankara; Control Atatürk; Periodontitis Ankara; Periodontitis Atatürk

Probing OTHER

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.

Control Ankara; Control Atatürk; Periodontitis Ankara; Periodontitis Atatürk

Saliva Collection (After treatment) DIAGNOSTIC_TEST

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.

Periodontitis Ankara; Periodontitis Atatürk

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karabuk University: lead
• Ataturk University: collaborator
• Ankara University: collaborator

Study Sites (2)

AnkaraUniversity

Ankara, 06560, Turkey (Türkiye)

Location

Karabuk University

Karabük, 78100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 12472994 BACKGROUND

Related Links

• Ethical approval was obtained from this related institution, as it used to be a clinical research board.

MeSH Terms

Conditions

Tobacco Smoking; Alveolar Bone Loss; Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof Dr

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 5, 2025
• Study Start: January 2, 2023
• Primary Completion: May 8, 2023
• Study Completion: July 3, 2023
• Last Updated: February 5, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Start date: 2 January, 2023 End date: 2 January, 2028
• Access Criteria: They may request the principal investigator to share the data of the study.

Locations

TU (2)