Periodontal DiseasesPAD-TMAONCT07449546
Periodontal Status and TMAO Levels in Peripheral Artery Disease
An observational study of Periodontal Diseases and Edentulism, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to evaluate the association between periodontal status and trimethylamine-N-oxide (TMAO) levels in patients diagnosed with peripheral artery disease (PAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Diseases, Edentulism, Peripheral Arterial Disease
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 15 Jan 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) with confirmed peripheral arterial disease (PAD) who were referred for vascular evaluation were enrolled in this cross-sectional observational study. Participants had intact limbs and were categorized according to their periodontal status as periodontitis, gingivitis, or edentulous (with self-reported history of tooth loss due to advanced periodontitis). All participants met the predefined inclusion and exclusion criteria prior to enrollment.
Who may be able to join
- Adults aged ≥18 years
- Confirmed diagnosis of Peripheral Arterial Disease (PAD), defined as: Ankle-Brachial Index (ABI) < 0.9 and/or angiographic or ultrasonographic evidence of arterial stenosis
- No limb amputation
- Presence of teeth and willingness to undergo full-mouth periodontal examination
- Edentulous status with self-reported history of complete tooth loss due to advanced periodontitis
- Ability to provide informed consent
Who cannot join
- Pregnant individuals
- Use of oral contraceptives
- Systemic antibiotic use within the previous 3 months
- Corticosteroid use within the previous 3 months
- Immunosuppressive therapy within the previous 3 months
- Chronic non-steroidal anti-inflammatory drug (NSAID) use within the previous 3 months
- Active periodontal treatment within the previous 6 months
- Periodontal surgery within the previous 1 year
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: Evaluation of the Effect of Periodontal Status on Serum and Salivary Trimethylamine N-Oxide Levels in Individuals With Peripheral Artery Disease
This observational study aims to evaluate the association between periodontal status and trimethylamine-N-oxide (TMAO) levels in patients diagnosed with peripheral artery disease (PAD). Both serum and saliva TMAO concentrations will be measured and compared according to periodontal health, periodontitis, and edentulism status. Clinical periodontal examinations and biological sample collection will be performed. The study seeks to investigate whether oral health status is associated with systemic TMAO levels in individuals with PAD.
Read the detailed description
This observational cross-sectional study is designed to investigate the relationship between periodontal status and trimethylamine-N-oxide (TMAO) levels in patients diagnosed with peripheral artery disease (PAD).
Adult patients with confirmed PAD will be included. Participants will undergo a full-mouth periodontal examination and will be categorized according to their periodontal status as periodontally healthy, periodontitis, or edentulous. Standard clinical periodontal parameters will be recorded.
Biological samples, including venous blood and unstimulated saliva, will be collected under standardized conditions. Serum and salivary TMAO levels will be analyzed using appropriate laboratory methods. The primary outcome is the comparison of serum and salivary TMAO concentrations according to periodontal status. Secondary outcomes include the evaluation of potential associations between periodontal clinical parameters and TMAO levels.
No intervention will be applied to participants. The study is observational and aims to explore the potential association between oral health status and systemic biomarkers in individuals with peripheral artery disease.
- Keywords
- Trimethylamine-N-oxide, Periodontal Disease, Edentulism, Peripheral Arterial Disease, Saliva, Serum
- Medical subject headings
- Periodontal Diseases, Peripheral Arterial Disease
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 |
|---|---|---|
| gingivitis | Patients diagnosed with gingivitis | |
| periodontitis | Patients diagnosed with periodontitis | |
| edentulism | Patients diagnosed with edentulism according to severe periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Trimethylamine-N-Oxide (TMAO) Levels (ng/ml)
Comparison of serum TMAO concentrations according to periodontal status (periodontitis, gingivitis, and edentulism).
Measured: At baseline (single time-point assessment)
Salivary Trimethylamine-N-oxide (TMAO) Level (ng/ml)
Comparison of salivary TMAO concentrations according to periodontal status (periodontitis, gingivitis, and edentulism).
Measured: At baseline (single time-point assessment)
Secondary outcomes (5)
Mean Periodontal Probing Depth (mm)
Mean probing depth measured in millimeters at six sites per tooth using a calibrated periodontal probe during full-mouth periodontal examination.
Measured: At baseline
Mean Clinical Attachment Loss (mm)
Mean clinical attachment loss measured in millimeters at six sites per tooth using a calibrated periodontal probe during full-mouth periodontal examination.
Measured: At baseline
Bleeding on Probing (%)
Percentage of sites exhibiting bleeding upon gentle probing at six sites per tooth during full-mouth periodontal examination.
Measured: At baseline
Plaque Index (mean score)
Mean plaque index score assessed at six sites per tooth during full-mouth periodontal examination using a standardized plaque index scoring system.
Measured: At baseline
Number of Remaining Teeth
Total number of natural teeth present in the oral cavity, recorded during full-mouth clinical examination.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start15 Feb 2022
- Primary completion10 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan AKDOĞAN, Ankara University
- Investigators
- Şivge Kurgan, DDS, PhD, Principal investigator, Ankara University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449546
- Sponsor's protocol ID
- 36290600/15/2022
- Acronym
- PAD-TMAO
- Status last verified
- Nov 2026
- First submitted
- 22 Feb 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including serum and salivary TMAO levels, periodontal clinical parameters, ABI values, and relevant biochemical markers) will be made available upon reasonable request to the corresponding author for scientifically sound research purposes, following institutional approval and in accordance with ethical regulations.
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
- Evaluation of the Effect of Periodontal Status on Serum and Salivary Trimethylamine N-Oxide Levels in Individuals With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT07449546
- Acronym / sponsor ID
- PAD-TMAO / 36290600/15/2022
- Keywords
- Trimethylamine-N-oxide, Periodontal Disease, Edentulism, Peripheral Arterial Disease, Saliva, Serum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 4 Mar 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 aims to evaluate the association between periodontal status and trimethylamine-N-oxide (TMAO) levels in patients diagnosed with peripheral artery disease (PAD). Both serum and saliva TMAO concentrations will be measured and compared according to periodontal health, periodontitis, and edentulism status. Clinical periodontal examinations and biological sample collection will be performed. The study seeks to investigate whether oral health status is associated with systemic TMAO levels in individuals with PAD.
Detailed description
This observational cross-sectional study is designed to investigate the relationship between periodontal status and trimethylamine-N-oxide (TMAO) levels in patients diagnosed with peripheral artery disease (PAD).
Adult patients with confirmed PAD will be included. Participants will undergo a full-mouth periodontal examination and will be categorized according to their periodontal status as periodontally healthy, periodontitis, or edentulous. Standard clinical periodontal parameters will be recorded.
Biological samples, including venous blood and unstimulated saliva, will be collected under standardized conditions. Serum and salivary TMAO levels will be analyzed using appropriate laboratory methods. The primary outcome is the comparison of serum and salivary TMAO concentrations according to periodontal status. Secondary outcomes include the evaluation of potential associations between periodontal clinical parameters and TMAO levels.
No intervention will be applied to participants. The study is observational and aims to explore the potential association between oral health status and systemic biomarkers in individuals with peripheral artery disease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| gingivitis | – | –Patients diagnosed with gingivitis |
| periodontitis | – | –Patients diagnosed with periodontitis |
| edentulism | – | –Patients diagnosed with edentulism according to severe periodontitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with confirmed peripheral arterial disease (PAD) who were referred for vascular evaluation were enrolled in this cross-sectional observational study. Participants had intact limbs and were categorized according to their periodontal status as periodontitis, gingivitis, or edentulous (with self-reported history of tooth loss due to advanced periodontitis). All participants met the predefined inclusion and exclusion criteria prior to enrollment.
Key inclusion criteria (6 listed)
- Adults aged ≥18 years
- Confirmed diagnosis of Peripheral Arterial Disease (PAD), defined as: Ankle-Brachial Index (ABI) < 0.9 and/or angiographic or ultrasonographic evidence of arterial stenosis
- No limb amputation
- Presence of teeth and willingness to undergo full-mouth periodontal examination
- Edentulous status with self-reported history of complete tooth loss due to advanced periodontitis
Key exclusion criteria (8 listed)
- Pregnant individuals
- Use of oral contraceptives
- Systemic antibiotic use within the previous 3 months
- Corticosteroid use within the previous 3 months
- Immunosuppressive therapy within the previous 3 months
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
Serum Trimethylamine-N-Oxide (TMAO) Levels (ng/ml)
Time frame: At baseline (single time-point assessment)
Comparison of serum TMAO concentrations according to periodontal status (periodontitis, gingivitis, and edentulism).
Salivary Trimethylamine-N-oxide (TMAO) Level (ng/ml)
Time frame: At baseline (single time-point assessment)
Comparison of salivary TMAO concentrations according to periodontal status (periodontitis, gingivitis, and edentulism).
5 secondary outcomes
Mean Periodontal Probing Depth (mm)
Time frame: At baseline
Mean Clinical Attachment Loss (mm)
Time frame: At baseline
Bleeding on Probing (%)
Time frame: At baseline
Plaque Index (mean score)
Time frame: At baseline
Number of Remaining Teeth
Time frame: At baseline
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: Yes. De-identified individual participant data (including serum and salivary TMAO levels, periodontal clinical parameters, ABI values, and relevant biochemical markers) will be made available upon reasonable request to the corresponding author for scientifically sound research purposes, following institutional approval and in accordance with 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.
Şivge Kurgan, 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 Periodontal Diseases and Edentulism, 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 6 inclusion and 8 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?
Serum Trimethylamine-N-Oxide (TMAO) Levels (ng/ml) (time frame: At baseline (single time-point assessment)). 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.