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Active, Not Recruiting

NCT Number: NCT07036289

Periodontitis Treatment and Heart Failure

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Taubate Dental School

Taubaté, São Paulo, 12020-330, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mechanical Treatment

Procedure

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

Primary outcomes

  1. NT-proBNP in blood samples

    Time frame: baseline versus 6 months

    Changes in NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels in blood samples. Higher levels indicate worse heart failure status.

Secondary outcomes

  1. Salivary NT-proBNP

    Time frame: baseline, 3 and 6 months

    Comparative NT-proBNP levels between blood and saliva samples at each time-point

  2. clinical pocket depth response

    Time frame: baseline, 3 and 6 months

    Changes in periodontal pocket depth (mm). Higher values indicate deeper periodontal pockets.

  3. clinical attachment level response

    Time frame: baseline, 3 and 6 months

    Changes in periodontal clinical attachment level (mm). Higher values indicate worse periodontal breakdown.

  4. clinical bleeding response

    Time frame: baseline, 3 and 6 months

    Changes in bleeding on probing (0 indicates absence and 1 presence of bleeding onto gentle periodontal probing).

  5. P. gingivalis bacterium salivary levels

    Time frame: baseline and 3 months

    P. gingivitis bacterium levels in saliva samples

  6. P. gingivalis antibody salivary levels

    Time frame: baseline and 3 months

    Antibodies against P. gingivitis in saliva samples

Sponsors and collaborators

Lead sponsor

University of Taubate

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Federal University of Minas Gerais
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Effects Of PeriodontitisTtreatment On The Worsening Of Heart Failure: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 25, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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