An interventional study of Non-surgical periodontal therapy in Periodontitis and Cardiac Electrophysiology, sponsored by University of Sao Paulo. Active, not recruiting at 1 site in Brazil. Open to participants aged 35 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Basic science
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.
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.
All participants will undergo complete periodontal examination, including probing depth, clinical attachment level, bleeding on probing, plaque index, and tooth loss assessment. Electrocardiographic recordings will be obtained for HRV analysis using time-domain, frequency-domain, symbolic, and nonlinear analyses, including entropy-based methods. Blood pressure measurements and anthropometric evaluations will also be performed.
Peripheral blood samples will be collected for analysis of pro-inflammatory cytokines, including IL-1α, IL-1β, TNF-α, IL-6, and IL-17, as well as anti-inflammatory cytokines such as IL-10. C-reactive protein and calcitonin levels will also be evaluated. Gingival crevicular fluid samples will be collected for local inflammatory marker analysis.
Supragingival biofilm and fecal samples will be collected for microbiological analysis using 16S rRNA sequencing in order to investigate oral and intestinal microbiome profiles and their association with autonomic and inflammatory parameters.
Cardiac structure and function will be evaluated through echocardiography, including conventional and speckle tracking echocardiographic analyses. Sympathetic neural activity will also be assessed by direct muscle sympathetic nerve activity recording through microneurography.
Participants diagnosed with periodontitis will receive non-surgical periodontal therapy, including scaling and root planing, oral hygiene instruction, and periodontal maintenance therapy throughout the study. Clinical and laboratory evaluations will be repeated at baseline, 3 months, 6 months, and 12 months after treatment.
The primary objective of this study is to determine whether periodontitis is associated with autonomic imbalance characterized by alterations in sympathetic and parasympathetic modulation. Secondary objectives include investigating associations among periodontal parameters, HRV indices, inflammatory biomarkers, blood pressure, cardiac function, and sympathetic activity, as well as evaluating the effects of periodontal treatment on these outcomes.
The findings of this study may contribute to a better understanding of the interactions among periodontal inflammation, systemic immune response, autonomic nervous system regulation, and cardiovascular function, potentially supporting new therapeutic and preventive approaches targeting neuroimmune mechanisms associated with chronic inflammatory diseases.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's planned enrollment of 50 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
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Exclusion Criteria:
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
Periodontally healthy participants or individuals without generalized severe periodontitis undergoing clinical and cardiovascular evaluation without periodontal intervention.
Non-surgical periodontal treatment including oral hygiene instruction, supragingival scaling, scaling and root planing, and periodontal maintenance therapy.
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).
Time frame: 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).
Time frame: 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 (%).
Time frame: 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.
Time frame: Baseline, 3 months, 6 months, and 12 months.
Periodontal clinical parameters (millimeters)
Assessment of periodontal clinical status using probing depth (PD) and clinical attachment level (CAL) measured in millimeters (mm).
Time frame: Baseline, 3 months, 6 months, and 12 months
Periodontal inflammatory parameters (percentage)
Assessment of periodontal inflammatory status using bleeding on probing (BOP), reported as the percentage of sites exhibiting bleeding on probing (%).
Time frame: Baseline, 3 months, 6 months, and 12 months.
Dental plaque accumulation (percentage)
Assessment of oral hygiene status using the plaque index, reported as the percentage of sites with visible dental plaque (%).
Time frame: Baseline, 3 months, 6 months, and 12 months.
Plan to share: No — Individual participant data will not be publicly available due to privacy and confidentiality restrictions.
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo