Effect of Smoking on Macrophage Polarization in Periodontitis

NCT07323277 | Completed

• 2 other identifiers: SDU-Perio-iNOS-ARG1-01TDK-2024-9512
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This observational case-control study investigates the effect of smoking on macrophage polarization in the pathogenesis of periodontitis. Adult participants who were either systemically healthy smokers or non-smokers, and who met the clinical criteria for periodontal health or periodontitis, were included. Gingival tissue samples were collected during periodontal procedures performed after completion of Phase I periodontal therapy, and the expression levels of macrophage polarization markers (iNOS and Arginase-1) were analyzed using ELISA. In addition, comprehensive clinical periodontal measurements-including probing pocket depth, clinical attachment level, bleeding on probing, Plaque Index, and Gingival Index-were recorded to evaluate the relationship between smoking status, inflammatory burden, and macrophage phenotype. The study aims to clarify how smoking modulates the balance between M1 and M2 macrophage responses in periodontal tissues.

Conditions

Periodontitis

Keywords

Smoking; Macrophage Polarization; M1/M2 Macrophages; iNOS; Arginase-1; Periodontal Inflammation; Periodontal Disease

Outcome Measures

Primary Outcomes (2)

• Gingival iNOS Level

  Concentration of inducible nitric oxide synthase (iNOS) in gingival tissue biopsies measured by ELISA (ng/mg tissue).

  At the time of periodontal surgery following completion of Phase I periodontal therapy.

• Gingival Arginase-1 Level

  Concentration of Arginase-1 in gingival tissue biopsies measured by ELISA (ng/mg tissue).

  At the time of periodontal surgery following completion of Phase I periodontal therapy.

Secondary Outcomes (5)

• Probing Pocket Depth (PPD)

  Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.

• Clinical Attachment Level (CAL)

  Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.

• Bleeding on Probing (BOP)

  Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.

• Plaque Index (PI)

  Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.

• Gingival Index (GI)

  Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.

Study Arms (4)

Healthy Non-Smokers

Systemically healthy individuals who do not smoke and present with clinically healthy periodontal status. Gingival tissue samples were collected after completion of Phase I periodontal therapy during routine periodontal procedures.

Periodontitis Non-Smokers

Systemically healthy individuals diagnosed with periodontitis who do not smoke. Gingival tissue biopsies were obtained after completion of Phase I periodontal therapy during periodontal surgical procedures.

Healthy Smokers

Systemically healthy individuals who smoke (≥10 cigarettes/day) and exhibit clinically healthy periodontal status. Gingival tissue samples were collected after completion of Phase I periodontal therapy during periodontal procedures.

Other: Smoking Exposure

Periodontitis Smokers

Systemically healthy individuals who smoke (≥10 cigarettes/day) and are clinically diagnosed with periodontitis. Gingival tissue samples were collected after completion of Phase I periodontal therapy during periodontal surgical procedures.

Other: Smoking Exposure

Interventions

Smoking Exposure OTHER

Exposure to cigarette smoking, defined as smoking ≥10 cigarettes per day. Participants were classified as smokers or non-smokers based on self-reported smoking status.

Healthy Smokers; Periodontitis Smokers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of systemically healthy volunteer adults aged 18-65 years who presented to the Periodontology Clinic of Süleyman Demirel University Faculty of Dentistry with a need for periodontal treatment. Eligible participants were assigned to one of four groups based on smoking status and periodontal condition: healthy non-smokers, periodontitis non-smokers, healthy smokers, and periodontitis smokers. All participants were evaluated according to the study's predefined inclusion and exclusion criteria before enrollment.

You may not qualify if:

• Individuals who did not consent to participate in the study
• History of any periodontal treatment within the past 6 months
• Use of systemic antibiotics within the past 3 months
• Pregnancy or lactation
• Psychological or physical conditions that may interfere with cooperation during clinical examination
• History of substance or alcohol abuse
• Presence of severe malocclusion or ongoing orthodontic treatment
• Acute dental pain due to caries, abscess, or other odontogenic infections
• Presence of systemic diseases with oral manifestations or any systemic condition known to affect periodontal tissues
• History of malignancy
• Use of medications that can influence periodontal parameters (e.g., anti-inflammatory drugs) within the past 3 months
• Participation in another scientific or clinical research study within the past 3 months

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Süleyman Demirel University Faculty of Dentistry, Department of Periodontology

Isparta, Isparta, 32000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gingival tissue biopsies (approximately 2×2 mm) collected during periodontal surgical procedures performed after completion of Phase I periodontal therapy. Samples were immediately stored at -80 °C and used for ELISA analysis of iNOS and Arginase-1.

MeSH Terms

Conditions

Periodontitis; Smoking; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Behavior

Study Officials

• Zuhal YETKİN AY, Prof. Dr.

  Süleyman Demirel University, Faculty of Dentistry, Department of Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate / Principal Investigator

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 7, 2026
• Study Start: December 1, 2024
• Primary Completion: July 15, 2025
• Study Completion: November 4, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)