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Clinical Trials in Brazil / NCT07036289
Active, not recruiting Not applicable

Periodontitis Treatment and Heart Failure

NCT07036289 · tracked via the Priya Life Science Brazil tracker
Sponsor
University of Taubate
Phase
Not applicable
Started
2025-06-10
Last updated
2026-02-13

Condition(s) studied

Heart FailurePeriodontitis

Investigational drug(s) / intervention(s)

Mechanical Treatment

Mechanical Treatment: manual quadrant scaling and root planing followed by dental prophylaxis within 4 weekly sections and oral hygiene instructions

Study summary

Heart failure (HF) is a rapidly growing public health issue affecting more than 40 million individuals globally; while gum disease with bone loss affects 50% of people in general. The objective of this study is to evaluate the effect of dental treatment on blood levels of a HF parameter at 3 and at 6 months. In addition to verify the relation between blood and salivary exam results and severity of HF. Imune response against one important oral bacterial will be also monitored at 3 and 6 months. Approximately 80 adult individuals will be included and divided into 3 groups. The first two groups will receive dental scaling and root planing (periodontitis individuals with heart failure \[n = 25\]; periodontitis individuals without heart failure \[n = 25\]). The third group named negative control will receive dental treatment only after 6 months of dental follow-up (periodontitis individuals with heart failure \[n = 25\]). HF treatment by oral medication will be continuous. Blood, salivary, microbiological and immune examinations will be performed in addition to the periodontal treatment of scaling and root planning. Clinical data will be obtained both for initial diagnosis and disease staging and for longitudinal follow-up.

Eligibility

Sex
ALL
Min age
35 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * minimum of 35 years of age; * possibility and availability for medical and dental examinations; * specifically for HF groups: HF having as primary causes ischemic problems, myocardial infarction, hypertension and valvulopathies will be selected * HF with intermediate or reduced ejection fraction under one of the three following pharmacological therapeutic regimens: a) Angiotensin Converting Enzyme Inhibitors, as the first option, or b) Angiotensin II Receptor Blockers and b) Angiotensin II Receptor Blockers and c) Angiotensin/neprilysin receptor inhibitors. Exclusion Criteria: * pregnant or lactating women; * individuals with stage D of HF using vasoactive drugs or circulatory devices; * HF individuals with preserved ejection fraction; * participants who do not meet the criteria for periodontal disease; * participants who are unable to comply with the study protocol; * diabetes, obesity, chronic kidney disease and other non-ischemic causes of HF; * familial and congenital heart alterations and myocarditis * rheumatological and autoimmune diseases; * drugs and cardiotoxic substances such as cocaine and oncological chemotherapy; * Specifically for the negative control group a progression of periodontitis revealed by 0.3mm additional clinical attachment loss within 6 months of follow-up.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of Taubate Dental School Taubaté São Paulo

More University of Taubate trials in Brazil

Other trials for the same condition

Official registry record

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.

View NCT07036289 on ClinicalTrials.gov ↗ ← All trials in Brazil