Non-surgical periodontal therapy: Non-surgical periodontal treatment including oral hygiene instruction, supragingival scaling, scaling and root planing, and periodontal maintenance therapy.
Study 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.
Eligibility
Sex
ALL
Min age
35 Years
Max age
50 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Autonomic modulation (frequency-domain analysis) — 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) — 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) — 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) — Baseline, 3 months, 6 months, and 12 months. Assessment of autonomic modulation using entropy derived from nonlinear heart rate variability analysis of electrocardiographic recordings.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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