Evaluation of the Effect of Periodontal Status on Serum and Salivary Trimethylamine N-Oxide Levels in Individuals With Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Serum Trimethylamine-N-Oxide (TMAO) Levels (ng/ml)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
gingivitis
Patients diagnosed with gingivitis
periodontitis
Patients diagnosed with periodontitis
edentulism
Patients diagnosed with edentulism according to severe periodontitis
结局指标
主要结局
Serum Trimethylamine-N-Oxide (TMAO) Levels (ng/ml)
时间窗: 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)
时间窗: At baseline (single time-point assessment)
Comparison of salivary TMAO concentrations according to periodontal status (periodontitis, gingivitis, and edentulism).
次要结局
- Number of Remaining Teeth(At baseline)
- Mean Periodontal Probing Depth (mm)(At baseline)
- Mean Clinical Attachment Loss (mm)(At baseline)
- Bleeding on Probing (%)(At baseline)
- Plaque Index (mean score)(At baseline)