Effects of Periodontitis on Heart Rate Variability (NCT07735312) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of Periodontitis on Heart Rate Variability
Brazil50 participantsStarted 2023-07-01
Plain-language summary
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.
Who can participate
Age range
35 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Completely edentulous individuals;
* Individuals presenting fewer than 15 teeth;
* Pregnant women;
* Smokers;
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Autonomic modulation (frequency-domain analysis)
Timeframe: Baseline, 3 months, 6 months, and 12 months
2
Autonomic modulation (normalized units)
Timeframe: Baseline, 3 months, 6 months, and 12 months.
3
Autonomic modulation (symbolic analysis)
Timeframe: Baseline, 3 months, 6 months, and 12 months.
4
Autonomic modulation (nonlinear analysis)
Timeframe: Baseline, 3 months, 6 months, and 12 months.