Effects of Periodontitis on Heart Rate Variability

NCT07735312 | Active Not Recruiting DMC

• 1 other identifier: 61203022.2.0000.5419
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Periodontitis; Cardiac Electrophysiology

Keywords

Periodontitis; Heart rate variability; Systemic Inflammation

Outcome Measures

Primary Outcomes (4)

• Autonomic modulation (frequency-domain analysis)

  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).

  Baseline, 3 months, 6 months, and 12 months

• Autonomic modulation (normalized units)

  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).

  Baseline, 3 months, 6 months, and 12 months.

• Autonomic modulation (symbolic analysis)

  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 (%).

  Baseline, 3 months, 6 months, and 12 months.

• Autonomic modulation (nonlinear analysis)

  Assessment of autonomic modulation using entropy derived from nonlinear heart rate variability analysis of electrocardiographic recordings.

  Baseline, 3 months, 6 months, and 12 months.

Secondary Outcomes (3)

• 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.

Study Arms (2)

Periodontitis

EXPERIMENTAL

Participants diagnosed with generalized stage III or IV, grade B or C periodontitis undergoing periodontal treatment and longitudinal clinical and cardiovascular evaluation.

Procedure: Non-surgical periodontal therapy

Control

NO INTERVENTION

Periodontally healthy participants or individuals without generalized severe periodontitis undergoing clinical and cardiovascular evaluation without periodontal intervention.

Interventions

Non-surgical periodontal therapy PROCEDURE

Non-surgical periodontal treatment including oral hygiene instruction, supragingival scaling, scaling and root planing, and periodontal maintenance therapy.

Periodontitis

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

FORP-USP

Ribeirão Preto, São Paulo, 14.040-904, Brazil

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 29, 2026
• Study Start: July 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)