Periodontitis Treatment and Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-10

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Heart failure (HF) is a rapidly growing public health issue with an estimated prevalence of \> 40 million individuals globally; while periodontitis affects 50% of people in general, and its most severe form affects approximately 11% of the population. The primary objective of this study is to evaluate the effect of periodontal therapy on blood levels of NT-proBNP (N-terminal pro-B-type natriuretic peptide) at 3 and at 6 months. Secondary aims are the relation between biomarker blood levels and a) functional classes and b) its salivary levels. Antibodies against P. gingivalis besides species' levels will be also determined initially and at 3 and 6 months. As 66 participants must complete the study, 75 to 85 individuals over 35 years of age will be included and randomly assigned to dental scaling and root planing (periodontitis individuals with heart failure \[n = 25\]; periodontitis individuals without heart failure \[n = 25\]) or negative control (periodontitis individuals with heart failure \[n = 25\]). 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. NT-proBNP and antibodies against P. gingivalis will be evaluated by enzyme immunoassay using commercially available kits while P. gingivalis levels will be determined by quantitative polymerase chain reaction (qPCR).

Conditions

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Heart Failure Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

statistics and laboratorial exams personnel

Study Groups

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periodontitis heart failure mechanical treatment

scaling and root planing plus oral hygiene instructions

Group Type EXPERIMENTAL

Mechanical Treatment

Intervention Type PROCEDURE

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

periodontitis mechanical treatment

scaling and root planing plus oral hygiene instructions

Group Type ACTIVE_COMPARATOR

Mechanical Treatment

Intervention Type PROCEDURE

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

periodontitis heart failure control

oral hygiene instructions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mechanical Treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes