Heart Failure, Periodontitis
Conditions
Keywords
scaling and root planing, heart failure, periodontitis, NT-proBNP, saliva, blood, Porphyromonas Gingivalis
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.
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).
Interventions
PROCEDUREMechanical Treatment
manual quadrant scaling and root planing followed by dental prophylaxis within 4 weekly sections and oral hygiene instructions
Sponsors
University of Taubate
Federal University of Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
statistics and laboratorial exams personnel
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NT-proBNP in blood samples | 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
| Measure | Time frame | Description |
|---|---|---|
| Salivary NT-proBNP | baseline, 3 and 6 months | Comparative NT-proBNP levels between blood and saliva samples at each time-point |
| clinical pocket depth response | baseline, 3 and 6 months | Changes in periodontal pocket depth (mm). Higher values indicate deeper periodontal pockets. |
| clinical attachment level response | baseline, 3 and 6 months | Changes in periodontal clinical attachment level (mm). Higher values indicate worse periodontal breakdown. |
| clinical bleeding response | baseline, 3 and 6 months | Changes in bleeding on probing (0 indicates absence and 1 presence of bleeding onto gentle periodontal probing). |
| P. gingivalis bacterium salivary levels | baseline and 3 months | P. gingivitis bacterium levels in saliva samples |
| P. gingivalis antibody salivary levels | baseline and 3 months | Antibodies against P. gingivitis in saliva samples |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORJose R Cortelli, Doctorate
University of Taubate
Outcome results
None listed