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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gingivitis | Patients diagnosed with gingivitis | ||
| periodontitis | Patients diagnosed with periodontitis | ||
| edentulism | Patients diagnosed with edentulism according to severe periodontitis |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum Trimethylamine-N-Oxide (TMAO) Levels (ng/ml) | Comparison of serum TMAO concentrations according to periodontal status (periodontitis, gingivitis, and edentulism). | 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). | At baseline (single time-point assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline |
| Mean Clinical Attachment Loss (mm) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Active Smoking (in years) | Total duration of active cigarette smoking reported by participants, expressed in years. | At baseline |
| Number of Cigarettes Smoked per Day (Cigarettes/day) | Average number of cigarettes smoked daily, as self-reported by participants. |
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Şivge Kurgan, DDS, PhD | Ankara University, Faculty of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University Faculty of Dentistry | Ankara | Ankara | 06560 | Turkey (Türkiye) |
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.
De-identified individual participant data will be available beginning 6 months after publication of the primary results and will remain available for 5 years upon reasonable request. Supporting documents including the study protocol and statistical analysis plan will also be available during this period. Access will be granted following institutional approval and in accordance with ethical regulations.
Access to de-identified individual participant data will be granted to qualified researchers upon submission of a methodologically sound research proposal. Requests will be reviewed by the principal investigator and the institutional review authority. Data will be shared following approval and execution of a data use agreement, in accordance with ethical and institutional regulations.
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
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Venous blood (serum) and unstimulated saliva samples were collected and stored for biochemical analysis of trimethylamine-N-oxide (TMAO) levels. No DNA extraction was performed.
Mean clinical attachment loss measured in millimeters at six sites per tooth using a calibrated periodontal probe during full-mouth periodontal examination.
| At baseline |
| Bleeding on Probing (%) | Percentage of sites exhibiting bleeding upon gentle probing at six sites per tooth during full-mouth periodontal examination. | 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. | At baseline |
| Number of Remaining Teeth | Total number of natural teeth present in the oral cavity, recorded during full-mouth clinical examination. | At baseline |
| At baseline |
| Duration Since Smoking Cessation (in years) | Time elapsed since smoking cessation among former smokers, expressed in years. | At baseline |
| Ankle-Brachial Index (ratio) | Ankle-brachial index calculated as the ratio of systolic blood pressure measured at the ankle to that measured at the brachial artery. | At baseline |
| Serum HDL Cholesterol Level (mg/dl) | Serum concentration of high-density lipoprotein cholesterol measured from venous blood samples. | At baseline |
| Serum LDL Cholesterol Level (mg/dl) | Serum concentration of low-density lipoprotein cholesterol measured from venous blood samples. | At baseline |
| Serum Total Cholesterol Level (mg/dl) | Total serum cholesterol concentration measured from venous blood samples. | At baseline |
| Serum Triglyceride Level (mg/dl) | Serum triglyceride concentration measured from venous blood samples. | At baseline |
| Serum High-Sensitivity C-Reactive Protein (hs-CRP) Level (mg/l) | Serum concentration of high-sensitivity C-reactive protein measured from venous blood samples as an indicator of systemic inflammation. | At baseline |
| Glycated Hemoglobin (HbA1c) Level (%) | Percentage of glycated hemoglobin measured from venous blood samples as an indicator of long-term glycemic control. | At baseline |
| Body Mass Index (kg/m²) | Body mass index calculated as weight in kilograms divided by the square of height in meters (kg/m²). | At baseline |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |