PeriodontitisPERIO-METANCT07897162
Effect of Smoking on Salivary and Serum Metabolomic Profiles in Periodontitis
An observational study of Periodontitis, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 31 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, Ankara, 06560
About this study
Official title: Effect of Smoking on Salivary and Serum Metabolomic Profiles in Patients With Periodontitis
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.
- Conditions
- Periodontitis
- Keywords
- Smoking, Metabolomics, Saliva, Serum
- Medical subject headings
- Periodontitis, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of study enrollment (single time point)
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.
Measured: At the time of study enrollment (single time point)
Secondary outcomes (4)
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.
Measured: At the time of study enrollment (single time point)
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.
Measured: At the time of study enrollment (single time point)
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.
Measured: At the time of study enrollment (single time point)
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.
Measured: At the time of study enrollment (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 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.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Nihan AKDOĞAN, Ankara University
- Investigators
- Canan Önder, DDS, PhD, Principal investigator, Ankara University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897162
- Sponsor's protocol ID
- 324S934
- Acronym
- PERIO-META
- Status last verified
- Nov 2026
- First submitted
- 5 Oct 2026
- Last updated
- 4 Nov 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 publicly shared due to participant confidentiality and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking on Salivary and Serum Metabolomic Profiles in Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT07897162
- Acronym / sponsor ID
- PERIO-META / 324S934
- Conditions
- Periodontitis
- Keywords
- Smoking, Metabolomics, Saliva, Serum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 27 Oct 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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relative Abundance of Salivary Metabolites
Time frame: At the time of study enrollment (single time point)
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.
Relative Abundance of Serum Metabolites
Time frame: At the time of study enrollment (single time point)
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.
4 secondary outcomes
Mean Probing Pocket Depth (PPD)
Time frame: At the time of study enrollment (single time point)
Mean Clinical Attachment Loss (CAL)
Time frame: At the time of study enrollment (single time point)
Mean Full-Mouth Plaque Index (PI)
Time frame: At the time of study enrollment (single time point)
Percentage of Sites with Bleeding on Probing (BOP)
Time frame: At the time of study enrollment (single time point)
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 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to participant confidentiality and ethical considerations.
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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.
Canan Önder, DDS, PhD principal investigator
Ankara University, Faculty of Dentistry
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 Ankara 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 8 inclusion and 9 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 4 Nov 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?
Relative Abundance of Salivary Metabolites (time frame: At the time of study enrollment (single time point)). 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 4 Nov 2026.