Periodontal and Cardiovascular Diseases Project

Impact of Basic Periodontal Therapy in the Levels of Porphyromonas Gingivalis and Aggregatibacter Actinomycetemcomitans Subgingival and Its Association With Vascular Function

The purpose of this study is to investigate whether basic periodontal therapy aim to reduce subgingival levels of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans, has an impact on the vascular function of patients suffering from established cardiovascular disease.

Design: randomized clinical trial, parallel design, double blinded.

Sample: 120 patients from the Cardiology Department of Hospital Severo Ochoa (Leganés, Madrid) suffering from established cardiovascular disease and generalized moderate/severe periodontitis. Sixty patients will be randomized to test group (scaling and root planing + systemic antimicrobials), and the other 60 subjects will be included in the control group, consisting on delayed periodontal treatment (supragingival prophylaxis + placebo).

Study visits:

Visit 1: screening Visit 2: baseline data collection (medical history, clinical variables, gingival crevicular fluid (GCF) samples, vascular function) Visit 3: panoramic x-ray, blood samples, randomization and first treatment session.

Visit 4: second treatment session. Visit 5: 24 hours inflammatory biomarkers assessment. Visit 6: 7 days inflammatory biomarkers assessment. Visit 7: 1 month follow up (clinical variables) Visit 8: 3 months follow up (clinical variables, vascular function) and supportive periodontal therapy.

Visit 9: 6 months follow up (clinical variables, GCF samples, inflammatory biomarkers, vascular function) and supportive periodontal therapy.

Inclusion Criteria:

• (1) patients with established cardiovascular disease (unstable angina or stroke in the previous 3 to 12 months, and left ventricular ejection fraction ≥50%);
• (2) diagnosis of moderate to severe generalized periodontitis (PD>5mm and marginal bone loss >30% on at least 50% of the teeth, according to Tonetti et al. 2007);
• (3) presence of at least 3 teeth per quadrant.

Exclusion Criteria:

• (1) periodontal treatment in the previous year;
• (2) antibiotic intake in the previous 3 months;
• (3) smokers of ≥10 cigarettes per day;
• (4) pregnancy or breast feeding;
• (5) diabetes mellitus types I or II, with glycosylated hemoglobin values >7;
• (6) necrotizing periodontal diseases;
• (7) HIV infection;
• (8) chronic intake of NSAID