Periodontal and Cardiovascular Diseases Project

Universidad Complutense de Madrid

Status: Terminated

Conditions: Periodontitis; Cardiovascular Diseases

Treatments: Procedure: Supragingival prophylaxis; Procedure: Scaling and root planing

Study type: Interventional

Funder types: Other

Identifiers

NCT02716259

PI11/00542 (Other Grant/Funding Number)

14/120-E_BS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

Scaling and root planing

Experimental group

Description:

Two sessions of scaling and root planing under local anesthesia and oral antiseptics (clorhexidine 0.12% rinse),

Treatment:

Procedure: Scaling and root planing

Supragingival prophylaxis

Placebo Comparator group

Description:

Two sessions of supragingival prophylaxis under local anesthesia and an oral rinse with no antiseptic properties.

Treatment:

Procedure: Supragingival prophylaxis