NCT02716259

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Periodontitis
• Cardiovascular Diseases

Interventions

Type	Name	Description
PROCEDURE	Scaling and root planing	Two sessions of scaling and root planing under local anesthesia and clorhexidine rinse twice/day, 15 days
PROCEDURE	Supragingival prophylaxis	Two sessions of scaling and root planing under local anesthesia and sodium fluoride rinse, twice/day, 15 days

Timeline

• Start date: 2016-02-19
• Primary completion: 2020-02-19
• Completion: 2020-02-20
• First posted: 2016-03-23
• Last updated: 2024-05-09

Locations

2 sites across 1 country: Spain