Edentulism, Periodontal Diseases, Peripheral Arterial Disease
Conditions
Keywords
Trimethylamine-N-oxide, Periodontal Disease, Edentulism, Peripheral Arterial Disease, Saliva, Serum
Brief 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). 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.
Interventions
None listed
Sponsors
Ankara University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Trimethylamine-N-Oxide (TMAO) Levels (ng/ml) | 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) | At baseline (single time-point assessment) | Comparison of salivary TMAO concentrations according to periodontal status (periodontitis, gingivitis, and edentulism). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Periodontal Probing Depth (mm) | At baseline | Mean probing depth measured in millimeters at six sites per tooth using a calibrated periodontal probe during full-mouth periodontal examination. |
| Mean Clinical Attachment Loss (mm) | At baseline | Mean clinical attachment loss measured in millimeters at six sites per tooth using a calibrated periodontal probe during full-mouth periodontal examination. |
| Bleeding on Probing (%) | At baseline | Percentage of sites exhibiting bleeding upon gentle probing at six sites per tooth during full-mouth periodontal examination. |
| Plaque Index (mean score) | At baseline | Mean plaque index score assessed at six sites per tooth during full-mouth periodontal examination using a standardized plaque index scoring system. |
| Number of Remaining Teeth | At baseline | Total number of natural teeth present in the oral cavity, recorded during full-mouth clinical examination. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORŞivge Kurgan, DDS, PhD
Ankara University, Faculty of Dentistry
Outcome results
None listed