Clinical trial NCT02716259: Periodontal and Cardiovascular Diseases Project
Official title: Impact of Basic Periodontal Therapy in the Levels of Porphyromonas Gingivalis and Aggregatibacter Actinomycetemcomitans Subgingival and Its Association With Vascular Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Periodontitis
Cardiovascular Diseases
Keywords: Periodontitis
Cardiovascular diseases
Bacteremia
Scaling and root planing
Flow-mediated dilation
carotid intima-media thickness
Porphyromonas gingivalis
Aggregatibacter actinomycetemcomitans
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2016-03-23
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Flow mediated dilation of the brachial artery
timeFrame: Day 0 (Baseline), Day 90, Day 180
Secondary outcomes:
measure: Carotid artery atherosclerosis
timeFrame: Day 0 (Baseline), Day 90, Day 180
measure: Periodontal pocket probing depth
timeFrame: Day 0 (baseline), Day 30, Day 90, Day 180
measure: Gingival recession
timeFrame: Day 0 (baseline), Day 30, Day 90, Day 180
measure: Plaque index
timeFrame: Day 0 (baseline), Day 30, Day 90, Day 180
measure: Bleeding on probing index
timeFrame: Day 0 (baseline), Day 30, Day 90, Day 180
measure: Suppuration on probing index
timeFrame: Day 0 (baseline), Day 30, Day 90, Day 180
measure: Dental mobility
timeFrame: Day 0 (baseline), Day 30, Day 90, Day 180
measure: Furcation lesions
timeFrame: Day 0 (baseline), Day 30, Day 90, Day 180
measure: Number of present teeth
timeFrame: Day 0 (baseline), Day 30, Day 90, Day 180
measure: Radiographic bone loss
timeFrame: Day 0 (baseline)
measure: Bacteria in gingival crevicular fluid
timeFrame: Day 0 (baseline), Day 180
measure: Bacteria in blood samples
timeFrame: Day 1 (pre and post-therapy)
measure: Inflammatory biomarkers in serum samples
timeFrame: Day 1, Day 3, Day 10, Day 180
Other outcomes:
Locations:
city: Leganes
country: Spain
facility: Severo Ochoa Hospital
state: Madrid
city: Madrid
country: Spain
facility: Faculty of dentistry, Complutense University Madrid
Study officials:
affiliation: Faculty of Dentistry, Complutense University of Madrid
name: Mariano Sanz, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Complutense University of Madrid
name: David Herrera, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Complutense University of Madrid
name: Elena Figuero, Professor
role: STUDY_DIRECTOR
affiliation: Servicio de Cardiología, Hospital Universitario Severo Ochoa
name: María Molina, Doctor
role: STUDY_CHAIR
References:
citation: Tonetti MS, D'Aiuto F, Nibali L, Donald A, Storry C, Parkar M, Suvan J, Hingorani AD, Vallance P, Deanfield J. Treatment of periodontitis and endothelial function. N Engl J Med. 2007 Mar 1;356(9):911-20. doi: 10.1056/NEJMoa063186.