Periodontitis Treatment and Heart Failure

NCT07036289 | Active Not Recruiting

• 3 other identifiers: CAAE 76621623.3.00000.55012023/07458-4306161/2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Periodontitis

Keywords

scaling and root planing; heart failure; periodontitis; NT-proBNP; saliva; blood; Porphyromonas Gingivalis

Outcome Measures

Primary Outcomes (1)

• NT-proBNP in blood samples

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

  baseline versus 6 months

Secondary Outcomes (6)

• Salivary NT-proBNP

  baseline, 3 and 6 months

• clinical pocket depth response

  baseline, 3 and 6 months

• clinical attachment level response

  baseline, 3 and 6 months

• clinical bleeding response

  baseline, 3 and 6 months

• P. gingivalis bacterium salivary levels

  baseline and 3 months

Study Arms (3)

periodontitis heart failure mechanical treatment

EXPERIMENTAL

scaling and root planing plus oral hygiene instructions

Procedure: Mechanical Treatment

periodontitis mechanical treatment

ACTIVE COMPARATOR

scaling and root planing plus oral hygiene instructions

Procedure: Mechanical Treatment

periodontitis heart failure control

NO INTERVENTION

oral hygiene instructions

Interventions

Mechanical Treatment PROCEDURE

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

periodontitis heart failure mechanical treatment; periodontitis mechanical treatment

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of Taubate Dental School

Taubaté, São Paulo, 12020-330, Brazil

Location

MeSH Terms

Conditions

Heart Failure; Periodontitis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jose R Cortelli, Doctorate

  University of Taubate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: statistics and laboratorial exams personnel
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dentist, specialist, master and doctorate

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 25, 2025
• Study Start: June 10, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)