Systemic Effect of Periodontal Therapy on Risk Markers of Acute Cardiovascular Events

Not Applicable

• Conditions: D23.101; C01.757; biomarkers; Periodontitis; cardiovascular diseases; sepsis; C07.465.714.533

• Registration Number: RBR-66tr7h
• Lead Sponsor: Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients will be selected based on the free demand of the Graduate Clinic of the Faculty of Dentistry of Ribeirão Preto. Sixty patients will be invited to participate in the study and will sign an informed consent form (TCLE) containing information about the objectives, risks and benefits of the study. All patients should have at least 14 natural teeth, at least 4 of them molars with at least 4 pockets with probing pocket depth greater or equal to 4 mm and 6 sites with clinical attachment level greater than 3 mm.

Exclusion Criteria

Patients with chronic inflammation or immunological conditions, such as arthritis, heart and kidney disease, smoking history, pregnancy and use of medication such as anti-inflammatories, antibiotics, immunosuppressants, or anticoagulants, will be excluded. Patients who withdraw from participating in the survey or who are unable to attend scheduled appointments will be excluded from the study, but they will continue to receive the necessary periodontal treatment. Special care will be taken for cardiac evaluation. The risk of cardiovascular events will be assessed previously in all patients selected according to the Brazilian Cardiology Association, where factors such as smoking, hypertension, overweight/ obesity, dyslipidemia, regular physical activity and psychosocial factors are evaluated (Simão et al., 2014). Patients who come into the medium or high-risk categories will be excluded from the study and instructed to look for specialized medical care.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of non-surgical periodontal treatment performed in a single or multiple sessions on risk biomarkers for acute cardiovascular events and sepsis through immunoenzymatic assays.

Secondary Outcome Measures

Name	Time	Method
Evaluate periodontal clinical parameters with a complete periodontal screening(probing depth mm- PD, clinical attachment loss mm- CAL, bleeding on probing %- BOP and plaque index % - PI) before and after basic periodontal therapy in normosystemic patients diagnosed with periodontitis.<br>;Evaluate and quantify the biomarkers (procalcitonin, copeptin, BNP, NT-proBNP, IL-6, TNF-alfa and c-reactive protein) in three moments: before periodontal therapy and after 24 and 48 hours of periodontal therapy through immunoenzymatic assays.;Set a plausibility of the systemic risk of periodontal treatment and, based on the biological events triggered and proven by the immunoenzymatic results of the biomarkers and the statistical analysis of these results through non-parametric tests, suggest less invasive approaches to minimize the risk and protect the patient..