Comparison of Saliva Biomarkers in Two Different Geographical Regions of Turkey

NCT ID: NCT06809439

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2023-07-03

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control Ankara

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.

Group Type: EXPERIMENTAL

Saliva Collection (Baseline)

Intervention Type: 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.

Probing

Intervention Type: 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 Atatürk

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.

Group Type: EXPERIMENTAL

Saliva Collection (Baseline)

Intervention Type: 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.

Probing

Intervention Type: 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.

Periodontitis Ankara

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.

Group Type: EXPERIMENTAL

Non-Surgical Intervention

Intervention Type: 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.

Saliva Collection (Baseline)

Intervention Type: 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.

Probing

Intervention Type: 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.

Saliva Collection (After treatment)

Intervention Type: 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 Atatürk

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.

Group Type: EXPERIMENTAL

Non-Surgical Intervention

Intervention Type: 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.

Saliva Collection (Baseline)

Intervention Type: 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.

Probing

Intervention Type: 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.

Saliva Collection (After treatment)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: OTHER

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: collaborator

Ankara University

OTHER

Sponsor Role: collaborator

Karabuk University

OTHER

Sponsor Role: lead

Responsible Party

Sevilay Yeğinoğlu

Asst Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AnkaraUniversity

Ankara, , Turkey (Türkiye)

Karabuk University

Karabük, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 12472994 (View on PubMed)

Related Links

https://www.dentistry.ankara.edu.tr/klinik-arastirmalari-etik-kurulu/

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

Other Identifiers

TSA-2022-2551

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ApprovalNo:11/04, 09.05.2022

Identifier Type: -

Identifier Source: org_study_id