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| ID | Type | Description | Link |
|---|---|---|---|
| 2023/07458-4 | Other Grant/Funding Number | FAPESP | |
| 306161/2023 | Other Grant/Funding Number | CNPQ |
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| Name | Class |
|---|---|
| Federal University of Minas Gerais | OTHER |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| periodontitis heart failure mechanical treatment | Experimental | scaling and root planing plus oral hygiene instructions |
|
| periodontitis mechanical treatment | Active Comparator | scaling and root planing plus oral hygiene instructions |
|
| periodontitis heart failure control | No Intervention | oral hygiene instructions |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical Treatment | Procedure | manual quadrant scaling and root planing followed by dental prophylaxis within 4 weekly sections and oral hygiene instructions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary NT-proBNP | Comparative NT-proBNP levels between blood and saliva samples at each time-point | baseline, 3 and 6 months |
| clinical pocket depth response | Changes in periodontal pocket depth (mm). Higher values indicate deeper periodontal pockets. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose R Cortelli, Doctorate | University of Taubate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Taubate Dental School | Taubaté | São Paulo | 12020-330 | Brazil |
Data will be analyzed by blind statistics and laboratorial staff and there is no need for sharing IPD.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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statistics and laboratorial exams personnel
| baseline, 3 and 6 months |
| clinical attachment level response | Changes in periodontal clinical attachment level (mm). Higher values indicate worse periodontal breakdown. | baseline, 3 and 6 months |
| clinical bleeding response | Changes in bleeding on probing (0 indicates absence and 1 presence of bleeding onto gentle periodontal probing). | baseline, 3 and 6 months |
| P. gingivalis bacterium salivary levels | P. gingivitis bacterium levels in saliva samples | baseline and 3 months |
| P. gingivalis antibody salivary levels | Antibodies against P. gingivitis in saliva samples | baseline and 3 months |
| D009057 |
| Stomatognathic Diseases |