Study of Autonomic Modulation - Sympathetic and Parasympathetic - in Periodontitis Through Heart Rate Variability
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Autonomic modulation (frequency-domain analysis)
研究概览
简要总结
Periodontitis is a chronic inflammatory disease associated with systemic inflammatory burden and possible alterations in autonomic nervous system regulation. Heart rate variability (HRV) has been used as a noninvasive method to assess autonomic modulation and may reflect sympathovagal imbalance associated with inflammatory conditions.
This case-control study aims to investigate the association between periodontitis and autonomic modulation assessed by HRV parameters. In addition, the study will evaluate the association between periodontal clinical parameters, HRV indices, and plasma levels of pro- and anti-inflammatory cytokines and biomarkers.
Participants with and without periodontitis will undergo periodontal examination, HRV assessment, and blood sample collection for inflammatory marker analyses.
详细描述
Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiotic dental biofilm and host immune-inflammatory response, leading to progressive destruction of tooth-supporting tissues. In addition to local periodontal inflammation, increasing evidence suggests that periodontitis contributes to systemic inflammatory burden and may be associated with cardiovascular and autonomic dysfunction.
The autonomic nervous system plays a central role in cardiovascular regulation and immune-inflammatory modulation. Sympathetic and parasympathetic pathways participate in inflammatory reflex mechanisms capable of modulating cytokine production and systemic inflammatory responses. Alterations in autonomic modulation have been associated with several chronic inflammatory conditions, including rheumatoid arthritis, systemic lupus erythematosus, sepsis, and cardiovascular diseases.
Heart rate variability (HRV) is a noninvasive and validated method for evaluating autonomic nervous system modulation and sympathovagal balance. Reduced HRV and increased sympathetic activity have been associated with systemic inflammation, cardiovascular morbidity, and increased mortality risk. However, the relationship between periodontitis and autonomic dysfunction remains incompletely understood, particularly regarding nonlinear HRV dynamics and their association with inflammatory biomarkers.
This longitudinal case-control study aims to investigate whether individuals with generalized periodontitis present alterations in autonomic modulation compared with periodontally healthy individuals. The study will evaluate HRV parameters, blood pressure, inflammatory biomarkers, cardiac function, and sympathetic neural activity. In addition, the effects of periodontal treatment on these parameters will be investigated over time.
Participants aged between 35 and 50 years will be recruited at the Periodontics Clinic of the School of Dentistry of Ribeirão Preto, University of São Paulo (FORP-USP). Individuals diagnosed with generalized stage III or IV, grade B or C periodontitis according to the 2017 Classification of Periodontal and Peri-Implant Diseases and Conditions will compose the test group. Periodontally healthy individuals or those not meeting periodontitis diagnostic criteria will compose the control group. Groups will be matched according to age and sex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 35 and 50 years;
- •Presence of at least 15 teeth, excluding third molars and teeth indicated for extraction;
- •Individuals diagnosed with generalized stage III or IV, grade B or C periodontitis according to the 2017 Classification of Periodontal and Peri-Implant Diseases and Conditions;
- •At least 30% of teeth presenting probing depth and clinical attachment loss ≥ 5 mm with bleeding on probing;
- •Ability and willingness to provide written informed consent.
排除标准
- •Completely edentulous individuals;
- •Individuals presenting fewer than 15 teeth;
- •Pregnant women;
- •Individuals diagnosed with type 1 or type 2 diabetes mellitus;
- •Individuals with chronic systemic diseases, including chronic arterial hypertension, class III or IV heart failure, or Parkinson's disease;
- •Individuals with pacemakers or atrial fibrillation/flutter;
- •Individuals who received periodontal treatment within the previous 12 months;
- •Individuals who used systemic antibiotics within the previous 6 months;
- •Individuals with contraindications to periodontal procedures;
- •Individuals requiring antibiotic prophylaxis before periodontal treatment;
- •Individuals with blood dyscrasias or anticoagulant conditions associated with increased bleeding risk.
结局指标
主要结局
Autonomic modulation (frequency-domain analysis)
时间窗: Baseline, 3 months, 6 months, and 12 months
Assessment of autonomic modulation using absolute low-frequency (LF) and high-frequency (HF) power derived from heart rate variability analysis of electrocardiographic recordings. Results will be reported as milliseconds squared (ms²).
Autonomic modulation (normalized units)
时间窗: Baseline, 3 months, 6 months, and 12 months.
Assessment of autonomic modulation using normalized low-frequency (LFnu) and high-frequency (HFnu) components derived from heart rate variability analysis of electrocardiographic recordings. Results will be reported as normalized units (nu).
Autonomic modulation (symbolic analysis)
时间窗: Baseline, 3 months, 6 months, and 12 months.
Assessment of autonomic modulation using symbolic analysis of heart rate variability, including the percentage of 0V and 2UV patterns. Results will be reported as percentages (%).
Autonomic modulation (nonlinear analysis)
时间窗: Baseline, 3 months, 6 months, and 12 months.
Assessment of autonomic modulation using entropy derived from nonlinear heart rate variability analysis of electrocardiographic recordings.
次要结局
- Periodontal clinical parameters (millimeters)(Baseline, 3 months, 6 months, and 12 months)
- Periodontal inflammatory parameters (percentage)(Baseline, 3 months, 6 months, and 12 months.)
- Dental plaque accumulation (percentage)(Baseline, 3 months, 6 months, and 12 months.)
研究者
Juliane Gonçalves da Fonseca
PhD Candidate
University of Sao Paulo