Arterial Hypertension
Conditions
Interventions
This is a randomized, controlled, parallel-group, two-arm, open-label clinical trial. The study includes 100 hypertensive patients with stage III/IV periodontitis and microvascular alterations. The te
the control group (CG) (n = 50 patients) will receive treatment after 6 months. Participants will be randomly allocated in a 1:1 ratio to the test group or control group through permuted block randomi
Sponsors
Faculdade de Odontologia da Universidade do Estado do Rio de Janeiro
Hospital Universitário Pedro Ernesto
Eligibility
Age
35 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients included in the study must meet the following criteria: male and female individuals; at least 12 teeth; 35 to 65 years of age; presence of stage III and IV periodontitis or absence of periodontitis; no periodontal treatment performed within the last 6 months; diagnosed hypertensive patients undergoing treatment for at least 4 weeks with systolic blood pressure (SBP) of 130 to 160 mmHg and/or diastolic blood pressure (DBP) of 80 to 100 mmHg; and signed informed consent form (ICF)
Exclusion criteria
Exclusion criteria: The following will be excluded from the study: patients with stage I and II periodontitis; individuals with human immunodeficiency virus (HIV) infection and other immunological disorders; pregnant and/or breastfeeding women; individuals with chronic inflammatory diseases such as diabetes mellitus and dyslipidemia; individuals with a history of heart failure, peripheral vascular disease, acute myocardial infarction (AMI), stroke, valvular disease, and other coronary diseases; patients who have used long-term medications within the six months prior to the start of the study or very frequently (more than 3 times per year), such as antibiotics, antihistamines, cortisone, hormones, nifedipine, and others that may have direct adverse effects on the periodontium; and individuals requiring antimicrobial prophylaxis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The hypothesis tested is based on the possibility that altered blood pressure may exacerbate the clinical signs of periodontal inflammation through vascular changes, and that periodontal treatment reduces blood pressure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in periodontal parameters is expected, such as probing pocket depth, gain in clinical attachment level, bleeding on probing index, plaque index, and periodontal inflamed surface area. In addition, improvement in inflammatory and systemic biomarkers is expected. | — |
Countries
BR
Contacts
Public ContactLívia Borges
Universidade do Estado do Rio de Janeiro
Outcome results
None listed