PeriodontitisNCT07323277
Effect of Smoking on Macrophage Polarization in Periodontitis
An observational study of Periodontitis, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Smoking Exposure
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 4 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- The study population consisted of volunteer participants aged 18-65 years who were referred to the Department of Periodontology at Süleyman Demirel University Faculty of Dentistry for periodontal treatment and who met the inclusion criteria without violating any exclusion criteria.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Süleyman Demirel University Faculty of Dentistry, Department of Periodontology
Isparta, Isparta, 32000
About this study
Official title: The Effect of Smoking on Macrophage Polarization in the Pathogenesis of Periodontitis
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.
Read the detailed description
Periodontitis is a chronic inflammatory disease in which macrophage polarization plays a key regulatory role in the host immune response. Smoking is a well-established risk factor that alters inflammatory pathways and immune cell behavior. This study was designed to examine how smoking influences macrophage polarization-specifically the balance between M1 (iNOS-mediated) and M2 (Arginase-1-mediated) phenotypes-in periodontal tissues.
Systemically healthy adult participants were recruited and categorized into four groups based on smoking status and periodontal condition: (1) healthy non-smokers, (2) periodontitis non-smokers, (3) healthy smokers, and (4) periodontitis smokers. Gingival tissue samples (approximately 2×2 mm) were collected during periodontal surgical procedures performed after completion of Phase I periodontal therapy, immediately stored at -80 °C, and processed for biochemical analysis. Comprehensive clinical periodontal measurements-including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), Plaque Index (PI), and Gingival Index (GI)-were recorded on the same day to evaluate periodontal status and inflammatory burden. ELISA was used to quantify iNOS and Arginase-1 levels in gingival tissues.
The primary objective of this study is to determine whether smoking shifts the macrophage phenotype toward a more pro-inflammatory M1 profile or suppresses M2-associated regulatory pathways in the context of periodontitis. The findings are expected to contribute to a better understanding of smoking-related alterations in periodontal immune mechanisms.
- Conditions
- Periodontitis
- Being tested
- Smoking Exposure
- Keywords
- Smoking, Macrophage Polarization, M1/M2 Macrophages, iNOS, Arginase-1, Periodontal Inflammation, Periodontal Disease
- Medical subject headings
- Periodontitis, Smoking, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking ExposureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Smoking Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival iNOS Level
Concentration of inducible nitric oxide synthase (iNOS) in gingival tissue biopsies measured by ELISA (ng/mg tissue).
Measured: 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).
Measured: At the time of periodontal surgery following completion of Phase I periodontal therapy.
Secondary outcomes (5)
Probing Pocket Depth (PPD)
Mean probing pocket depth (mm) recorded at six sites per tooth using a periodontal probe.
Measured: Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.
Clinical Attachment Level (CAL)
Clinical attachment level (mm) recorded at six sites per tooth using a periodontal probe.
Measured: Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.
Bleeding on Probing (BOP)
Bleeding on probing percentage calculated as the proportion of bleeding sites to total sites examined.
Measured: Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.
Plaque Index (PI)
Dental plaque accumulation assessed using the Silness and Löe Plaque Index. Plaque scores were recorded at four surfaces per tooth and scored on a scale from 0 to 3, where 0 indicates no plaque and 3 indicates abundant plaque accumulation. Higher scores indicate worse plaque status.
Measured: Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.
Gingival Index (GI)
Gingival inflammation assessed using the Löe and Silness Gingival Index. Gingival Index scores were recorded at four surfaces per tooth and scored on a scale from 0 to 3, where 0 indicates normal gingiva and 3 indicates severe gingival inflammation. Higher scores indicate worse gingival status.
Measured: Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Dec 2024
- Primary completion15 Jul 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli Ege Ozdamar, Suleyman Demirel University
- Investigators
- Zuhal YETKİN AY, Prof. Dr., Principal investigator, Süleyman Demirel University, Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323277
- Sponsor's protocol ID
- SDU-Perio-iNOS-ARG1-01
- Other IDs
- TDK-2024-9512
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this study is a single-center thesis research project, and data sharing is not permitted under institutional and ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Smoking on Macrophage Polarization in the Pathogenesis of Periodontitis
- ClinicalTrials.gov ID
- NCT07323277
- Acronym / sponsor ID
- SDU-Perio-iNOS-ARG1-01
- Conditions
- Periodontitis
- Keywords
- Smoking, Macrophage Polarization, M1/M2 Macrophages, iNOS, Arginase-1, Periodontal Inflammation, Periodontal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Periodontitis is a chronic inflammatory disease in which macrophage polarization plays a key regulatory role in the host immune response. Smoking is a well-established risk factor that alters inflammatory pathways and immune cell behavior. This study was designed to examine how smoking influences macrophage polarization-specifically the balance between M1 (iNOS-mediated) and M2 (Arginase-1-mediated) phenotypes-in periodontal tissues.
Systemically healthy adult participants were recruited and categorized into four groups based on smoking status and periodontal condition: (1) healthy non-smokers, (2) periodontitis non-smokers, (3) healthy smokers, and (4) periodontitis smokers. Gingival tissue samples (approximately 2×2 mm) were collected during periodontal surgical procedures performed after completion of Phase I periodontal therapy, immediately stored at -80 °C, and processed for biochemical analysis. Comprehensive clinical periodontal measurements-including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), Plaque Index (PI), and Gingival Index (GI)-were recorded on the same day to evaluate periodontal status and inflammatory burden. ELISA was used to quantify iNOS and Arginase-1 levels in gingival tissues.
The primary objective of this study is to determine whether smoking shifts the macrophage phenotype toward a more pro-inflammatory M1 profile or suppresses M2-associated regulatory pathways in the context of periodontitis. The findings are expected to contribute to a better understanding of smoking-related alterations in periodontal immune mechanisms.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Smoking ExposureSystemically 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. |
| Periodontitis Smokers | – | Other: Smoking ExposureSystemically 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- The study population consisted of volunteer participants aged 18-65 years who were referred to the Department of Periodontology at Süleyman Demirel University Faculty of Dentistry for periodontal treatment and who met the inclusion criteria without violating any exclusion criteria.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking ExposureExposure to cigarette smoking, defined as smoking ≥10 cigarettes per day. Participants were classified as smokers or non-smokers based on self-reported smoking status. | Other | Healthy Smokers, Periodontitis Smokers |
Primary outcome
Gingival iNOS Level
Time frame: At the time of periodontal surgery following completion of Phase I periodontal therapy.
Concentration of inducible nitric oxide synthase (iNOS) in gingival tissue biopsies measured by ELISA (ng/mg tissue).
Gingival Arginase-1 Level
Time frame: At the time of periodontal surgery following completion of Phase I periodontal therapy.
Concentration of Arginase-1 in gingival tissue biopsies measured by ELISA (ng/mg tissue).
5 secondary outcomes
Probing Pocket Depth (PPD)
Time frame: Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.
Clinical Attachment Level (CAL)
Time frame: Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.
Bleeding on Probing (BOP)
Time frame: Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.
Plaque Index (PI)
Time frame: Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.
Gingival Index (GI)
Time frame: Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this study is a single-center thesis research project, and data sharing is not permitted under institutional and ethical regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zuhal YETKİN AY, Prof. Dr. principal investigator
Süleyman Demirel University, Faculty of Dentistry, Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival iNOS Level (time frame: At the time of periodontal surgery following completion of Phase I periodontal therapy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.