Periodontal and Cardiovascular Diseases Project

Phase

N/A

Condition

Vascular Diseases

Periodontitis

Treatment

Supragingival prophylaxis

Scaling and root planing

Clinical Study ID

NCT02716259

14/120-E_BS

PI11/00542

All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

(1) patients with established cardiovascular disease (unstable angina or stroke in theprevious 3 to 12 months, and left ventricular ejection fraction ≥50%);
(2) diagnosis of moderate to severe generalized periodontitis (PD>5mm and marginalbone 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

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

Study Design

Supragingival prophylaxis

February 19, 2016

February 20, 2020

Study Description

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.

Connect with a study center

Severo Ochoa Hospital
Leganes, Madrid
Spain
Site Not Available
Faculty of dentistry, Complutense University Madrid
Madrid, 28040
Spain
Site Not Available

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