NCT07036289

Periodontitis Treatment and Heart Failure

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Taubate · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Heart Failure
• Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Mechanical Treatment	manual quadrant scaling and root planing followed by dental prophylaxis within 4 weekly sections and oral hygiene instructions

Timeline

• Start date: 2025-06-10
• Primary completion: 2025-12-30
• Completion: 2026-12-01
• First posted: 2025-06-25
• Last updated: 2026-02-13

Locations

1 site across 1 country: Brazil