Periodontitis Treatment and Heart Failure

University of Taubate

Status: Invitation-only

Conditions: Periodontitis; Heart Failure

Treatments: Procedure: Mechanical Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07036289

CAAE 76621623.3.00000.5501

306161/2023 (Other Grant/Funding Number)

2023/07458-4 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 85 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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85 participants in 3 patient groups

periodontitis heart failure mechanical treatment

Experimental group

Description:

scaling and root planing plus oral hygiene instructions

Treatment:

Procedure: Mechanical Treatment

periodontitis mechanical treatment

Active Comparator group

Description:

scaling and root planing plus oral hygiene instructions

Treatment:

Procedure: Mechanical Treatment

periodontitis heart failure control

No Intervention group

Description:

oral hygiene instructions