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NCT Number: NCT07449546

Periodontal Status and TMAO Levels in 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.

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Key information

Conditions

Periodontal Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Edentulism Mouth Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Stomatognathic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Faculty of Dentistry

Ankara, 06560, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Mean Periodontal Probing Depth (mm)

    Time frame: At baseline

    Mean probing depth measured in millimeters at six sites per tooth using a calibrated periodontal probe during full-mouth periodontal examination.

  2. Mean Clinical Attachment Loss (mm)

    Time frame: At baseline

    Mean clinical attachment loss measured in millimeters at six sites per tooth using a calibrated periodontal probe during full-mouth periodontal examination.

  3. Bleeding on Probing (%)

    Time frame: At baseline

    Percentage of sites exhibiting bleeding upon gentle probing at six sites per tooth during full-mouth periodontal examination.

  4. Plaque Index (mean score)

    Time frame: At baseline

    Mean plaque index score assessed at six sites per tooth during full-mouth periodontal examination using a standardized plaque index scoring system.

  5. Number of Remaining Teeth

    Time frame: At baseline

    Total number of natural teeth present in the oral cavity, recorded during full-mouth clinical examination.

Other outcomes

  1. Duration of Active Smoking (in years)

    Time frame: At baseline

    Total duration of active cigarette smoking reported by participants, expressed in years.

  2. Number of Cigarettes Smoked per Day (Cigarettes/day)

    Time frame: At baseline

    Average number of cigarettes smoked daily, as self-reported by participants.

  3. Duration Since Smoking Cessation (in years)

    Time frame: At baseline

    Time elapsed since smoking cessation among former smokers, expressed in years.

  4. Ankle-Brachial Index (ratio)

    Time frame: At baseline

    Ankle-brachial index calculated as the ratio of systolic blood pressure measured at the ankle to that measured at the brachial artery.

  5. Serum HDL Cholesterol Level (mg/dl)

    Time frame: At baseline

    Serum concentration of high-density lipoprotein cholesterol measured from venous blood samples.

  6. Serum LDL Cholesterol Level (mg/dl)

    Time frame: At baseline

    Serum concentration of low-density lipoprotein cholesterol measured from venous blood samples.

  7. Serum Total Cholesterol Level (mg/dl)

    Time frame: At baseline

    Total serum cholesterol concentration measured from venous blood samples.

  8. Serum Triglyceride Level (mg/dl)

    Time frame: At baseline

    Serum triglyceride concentration measured from venous blood samples.

  9. Serum High-Sensitivity C-Reactive Protein (hs-CRP) Level (mg/l)

    Time frame: At baseline

    Serum concentration of high-sensitivity C-reactive protein measured from venous blood samples as an indicator of systemic inflammation.

  10. Glycated Hemoglobin (HbA1c) Level (%)

    Time frame: At baseline

    Percentage of glycated hemoglobin measured from venous blood samples as an indicator of long-term glycemic control.

  11. Body Mass Index (kg/m²)

    Time frame: At baseline

    Body mass index calculated as weight in kilograms divided by the square of height in meters (kg/m²).

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Evaluation of the Effect of Periodontal Status on Serum and Salivary Trimethylamine N-Oxide Levels in Individuals With Peripheral Artery Disease

Acronym: PAD-TMAO

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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