EVALUATION OF SALIVARY BİOMARKER LEVELS IN SMOKING AND NON-SMOKER INDIVIDUALS WITH DIFFERENT PERIODONTAL DISEASES

NCT06971770 | Completed

• 1 other identifier: 2023-TDU-DİŞF-0016
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare various cytokine levels in saliva samples in order to understand the pathogenesis of chronic inflammatory diseases. In particular, HMGB1, sTREM-1 and TNF-α levels were examined between smokers and non-smokers with periodontitis and non-smokers with gingivitis and periodontally healthy individuals. 80 systemically healthy individuals were included in the study. These individuals were divided into four groups: 20 non-smoker periodontally healthy, 20 non-smoker with gingivitis, 20 non- smokers with periodontitis and 20 smokers with periodontitis. Periodontal clinical parameters of each individual were measured and saliva samples were taken. HMGB1, sTREM-1 and TNF-α levels in the saliva samples were determined by enzyme-linked immunoassay (ELISA) method. Statistical analyses were performed on the data to examine the differences in cytokine levels between the groups and the relationships of these cytokines with clinical parameters. The findings obtained may contribute to the research of potential biomarkers that can be used in the diagnosis of periodontal diseases and new ways of treatment processes.

Conditions

Periodontal Diseases

Keywords

gingivitis; periodontitis; smoking; tnf-a; sTREM-1; HMGB-1

Outcome Measures

Primary Outcomes (3)

• Salivary TNF-α levels

  the total amount of TNF-α in saliva

  24 hours after taking the clinical measurements at the first visit

• Salivary sTREM-1 level

  the total amount of sTREM-1 in saliva

  24 hours after taking the clinical measurements at the first visit

• Salivary HMGB-1 levels

  the total amount of HMGB-1 in saliva

  24 hours after taking the clinical measurements at the first visit

Secondary Outcomes (5)

• Probing Depth

  during the initial visit

• clinical attachment level

  during the initial visit

• Plaque Index

  during the initial visit

• gingival index

  during the initial visit

• bleeding on probing

  during the initial visit

Study Arms (4)

Healthy periodontium

EXPERIMENTAL

Individuals who, in the evaluation made in 6 areas of each tooth, had bleeding on probing in less than 10% of the areas, had a probing depth of less than 4 mm and had no attachment loss.

Diagnostic Test: saliva obtaining

gingivitis

EXPERIMENTAL

Individuals who have bleeding on probing in more than 10% of the areas, a probing depth of less than 4 mm and no attachment loss, based on an evaluation of 6 areas of each tooth.

Diagnostic Test: saliva obtaining

non-smoker periodontitis

EXPERIMENTAL

Individuals who have bleeding on probing in 30% or more areas according to the evaluation made in 6 areas of each tooth, who have a probing pocket depth of 5 mm or more in at least 2 non-adjacent teeth in each quadrant of the jaw and who have attachment loss of 4 mm or more, and who have coronal 1/3 or more (horizontal and/or vertical) bone loss on radiographs.

Diagnostic Test: saliva obtaining

smoker periodontitis

EXPERIMENTAL

Individuals who smoke at least 10 cigarettes a day, who have bleeding on probing in 30% or more areas according to the evaluation made in 6 areas of each tooth, who have a probing pocket depth of 5 mm or more in at least 2 non-adjacent teeth in each quadrant of the jaw and who have attachment loss of 4 mm or more, and who have coronal 1/3 or more (horizontal and/or vertical) bone loss on radiographs.

Diagnostic Test: saliva obtaining

Interventions

saliva obtaining DIAGNOSTIC_TEST

The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Tubes were stored at -80ºC until the day of analysis.

Healthy periodontium; gingivitis; non-smoker periodontitis; smoker periodontitis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy (Determination of volunteers will be based on patient statements in the anamnesis. No additional examination will be performed.)
• At least 16 permanent teeth in the mouth
• For non-smoking groups: never smoked
• For the smoking group: smoking at least 10 cigarettes per day
• No continuously used medications
• No use of antibiotics, anti-inflammatory drugs, and systemic corticosteroids in the last 6 months
• Not pregnant or breastfeeding
• No periodontal treatment in the last 6 months
• For the Periodontitis group: based on the evaluation of 6 sites per tooth, ≥30% bleeding on probing, probing depth ≥5 mm and clinical attachment loss ≥4 mm in at least 2 non-adjacent teeth in a quadrant, and radiographic bone loss of coronal 1/3 or more (horizontal and/or vertical)
• For the Gingivitis group: based on the evaluation of 6 sites per tooth, ≥10% bleeding on probing, probing depth \<4 mm, and no clinical attachment loss
• For the Healthy group: based on the evaluation of 6 sites per tooth, \<10% bleeding on probing, probing depth \<4 mm, and no clinical attachment loss.

You may not qualify if:

• Any oral or systemic disease
• Regularly using a systemic medication
• During pregnancy or lactation
• Received periodontal treatment within the last 6 months.
• Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Çelebi University Department of Periodontology

Izmir, Çiğli, 35640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases; Gingivitis; Periodontitis; Smoking

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant of Periodontology

Model Details: According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) samples of saliva were obtained from systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20) and with 20 systemically healthy smoker individuals with periodontitis (PS, n=20)

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 14, 2025
• Study Start: April 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)