Effects of Periodontitis on Heart Rate Variability | NCT07735312

NCT07735312

Overview

NCT ID: NCT07735312
Lead Sponsor: University of Sao PauloOTHER
Official Title: Study of Autonomic Modulation - Sympathetic and Parasympathetic - in Periodontitis Through Heart Rate Variability
Brief 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.
Conditions

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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.