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CompletedNCT07897162PERIO-METAUpdated Nov 4, 2026

Effect of Smoking on Salivary and Serum Metabolomic Profiles in Periodontitis

An observational study in Periodontitis, sponsored by Ankara University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Ankara University · Observational

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
48
Ages
18 Years and older
Sex
All
01

Study summary

This observational study investigated the effect of smoking on salivary and serum metabolomic profiles in individuals with and without periodontitis. Participants were classified into four groups according to periodontal status and smoking status: periodontally healthy non-smokers, periodontally healthy smokers, non-smokers with periodontitis, and smokers with periodontitis. Periodontal clinical parameters were recorded, and saliva and blood samples were collected from all participants. Metabolomic analyses were performed to identify metabolic alterations associated with periodontitis, smoking, and their combined presence, and to compare salivary and serum metabolomic profiles across the study groups.

02

Conditions studied

  • Periodontitis

Keywords

  • Smoking
  • Metabolomics
  • Saliva
  • Serum
03

In context

Periodontitis

1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.

This study's enrollment of 48 is below the median of 90 across 372 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Ankara University is the lead sponsor of 320 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults aged 18-65 years were included and classified into four groups according to periodontal status and smoking status: periodontally healthy non-smokers, periodontally healthy smokers, non-smokers with periodontitis, and smokers with periodontitis. Each group consisted of 12 participants, for a total study population of 48 participants. Periodontal status was determined by clinical periodontal examination, and smoking status was defined according to the prespecified eligibility criteria.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years.
  • No orthodontic appliance use.
  • Women who are not pregnant or lactating.
  • No systemic disease that may affect periodontal health.
  • No use of anti-inflammatory and/or antimicrobial medications within the previous 6 months.
  • No periodontal treatment within the previous 12 months.
  • For the smoker groups: smoking ≥10 cigarettes/day for at least 5 years.
  • For the non-smoker groups: no smoking for at least the previous 2 years.

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years.
  • Pregnancy or lactation.
  • Use of anti-inflammatory and/or antimicrobial medications within the previous 6 months.
  • Periodontal treatment within the previous 12 months.
  • Psychiatric disease.
  • Presence of any oral infection.
  • Alcohol dependence.
  • Active infectious disease (acute hepatitis, AIDS, or tuberculosis), cancer, or any systemic disease that may affect periodontal tissues.
  • Treatment with medications known to affect periodontal tissues, including phenytoin, cyclosporine A, or calcium channel blockers.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
48 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Periodontitis - Smoker

    Participants with periodontitis who were current smokers.

  • Periodontitis - Non-Smoker

    Participants with periodontitis who were non-smokers.

  • Periodontally Healthy - Smoker

    Periodontally healthy participants who were current smokers.

  • Periodontally Healthy - Non-Smoker

    Periodontally healthy participants who were non-smokers.

06

What researchers measure

Primary outcomes

  1. Relative Abundance of Salivary Metabolites

    Salivary metabolites will be analyzed using mass spectrometry-based untargeted metabolomic profiling. Relative metabolite abundances will be measured and compared among the four study groups according to periodontal and smoking status.

    Time frame: At the time of study enrollment (single time point)

  2. Relative Abundance of Serum Metabolites

    Serum metabolites will be analyzed using mass spectrometry-based untargeted metabolomic profiling. Relative metabolite abundances will be measured and compared among the four study groups according to periodontal and smoking status.

    Time frame: At the time of study enrollment (single time point)

Secondary outcomes

  1. Mean Probing Pocket Depth (PPD)

    Probing pocket depth (PPD) will be measured in millimeters (mm) using a periodontal probe. Mean PPD values will be calculated for each participant and compared among the four study groups.

    Time frame: At the time of study enrollment (single time point)

  2. Mean Clinical Attachment Loss (CAL)

    Clinical attachment loss (CAL) will be measured in millimeters (mm) using a periodontal probe. Mean CAL values will be calculated for each participant and compared among the four study groups.

    Time frame: At the time of study enrollment (single time point)

  3. Mean Full-Mouth Plaque Index (PI)

    Plaque Index (PI) will be assessed at six sites per tooth using a four-point scoring system (0-3): 0 = no plaque; 1 = thin plaque deposits; 2 = visible plaque accumulation in masses; and 3 = presence of dental calculus. The mean full-mouth PI score will be calculated by averaging the scores across all examined sites. Higher scores indicate greater plaque and/or calculus accumulation.

    Time frame: At the time of study enrollment (single time point)

  4. Percentage of Sites with Bleeding on Probing (BOP)

    Bleeding on probing (BOP) will be assessed during periodontal examination and expressed as the percentage of bleeding sites relative to the total number of examined sites. BOP percentages will be compared among the four study groups.

    Time frame: At the time of study enrollment (single time point)

07

Study locations

1 site
  • Ankara University Faculty of Dentistry
    Ankara, Ankara 06560, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be publicly shared due to participant confidentiality and ethical considerations.

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2024 to primary completion in Mar 2025, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2026
First posted
Oct 27, 2026
StartActual
Nov 1, 2024
Primary completionActual
Mar 31, 2025
CompletionActual
Mar 31, 2025
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 2 updates
  1. Nov 4, 2026
    Minor edits only
    + 1 other change: verification date
  2. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07897162
Lead sponsor
Ankara University
Collaborators
The Scientific and Technological Research Council of Turkey
Responsible party
Nihan AKDOĞAN (Principal Investigator, Ankara University) — Principal investigator
First posted
Oct 27, 2026
Start date
Nov 1, 2024
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025
Last update
Nov 4, 2026

Study contacts

Canan Önder, DDS, PhD
principal investigator · Ankara University, Faculty of Dentistry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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