Periodontal and Cardiovascular Diseases Project
- Conditions
- Cardiovascular DiseasesPeriodontitis
- Interventions
- Procedure: Scaling and root planingProcedure: Supragingival prophylaxis
- Registration Number
- NCT02716259
- Lead Sponsor
- Universidad Complutense de Madrid
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 36
- (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.
- (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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Scaling and root planing Scaling and root planing Two sessions of scaling and root planing under local anesthesia and oral antiseptics (clorhexidine 0.12% rinse), Supragingival prophylaxis Supragingival prophylaxis Two sessions of supragingival prophylaxis under local anesthesia and an oral rinse with no antiseptic properties.
- Primary Outcome Measures
Name Time Method Flow mediated dilation of the brachial artery Day 0 (Baseline), Day 90, Day 180 Endothelium-dependent vasodilatation of the brachial artery assessed by means of ultrasound imaging with the use of a 7-MHz linear probe and vessel diameter measurements. Dilatation was quantified as the change in percentage form a baseline measurement and a second measurement taken after 5 minutes of flow ischemia induced with a sphygmomanometer cuff placed on the forearm.
- Secondary Outcome Measures
Name Time Method Carotid artery atherosclerosis Day 0 (Baseline), Day 90, Day 180 Intima-media thickness of the carotid artery assessed by means of ultrasound imaging with the use of a 7-MHz linear probe and an automated imaging software.
Plaque index Day 0 (baseline), Day 30, Day 90, Day 180 Presence or absence of dental plaque around teeth, measured in 6 sites per tooth with a periodontal probe of the University of North Caroline (UNC)-15.
Dental mobility Day 0 (baseline), Day 30, Day 90, Day 180 Presence of dental mobility, recorded according to Miller´s classification: 0: absence of mobility; 1: horizontal mobility \<1mm; 2: horizontal mobility \>1mm; 3: horizontal and vertical mobility.
Bacteria in blood samples Day 1 (pre and post-therapy) Total counts (CFU/ml) and percentage of the flora of anaerobic bacteria present in blood samples before and 10 minutes after the intervention. Samples will be processed by means of culture and quantitative polymerase chain reaction
Bacteria in gingival crevicular fluid Day 0 (baseline), Day 180 Total counts (CFU/ml) and percentage of the flora of anaerobic bacteria present in gingival crevicular fluid. Samples will be processed by means of culture and quantitative polymerase chain reaction
Gingival recession Day 0 (baseline), Day 30, Day 90, Day 180 Distance from the gingival margin to the cementum-enamel junction, measured in 6 sites per tooth with a periodontal probe UNC-15.
Inflammatory biomarkers in serum samples Day 1, Day 3, Day 10, Day 180 Levels of inflammatory biomarkers (interleukin 6, C reactive protein, e-selectin) and coagulation factors (d-dimer, prothrombin, fibrinogen, Von Willebrand factor) in serum, assessed by means of Luminex technique (Bio-Plex Pro-Assays kit).
Periodontal pocket probing depth Day 0 (baseline), Day 30, Day 90, Day 180 Distance from the gingival margin to the base of the periodontal pocket, measured in 6 sites per tooth with a periodontal probe UNC-15.
Bleeding on probing index Day 0 (baseline), Day 30, Day 90, Day 180 Presence or absence of bleeding 30 seconds after probing, measured in 6 sites per tooth with a periodontal probe UNC-15.
Suppuration on probing index Day 0 (baseline), Day 30, Day 90, Day 180 Presence or absence of gingival suppuration 30 seconds after probing, measured in 6 sites per tooth with a periodontal probe UNC-15.
Furcation lesions Day 0 (baseline), Day 30, Day 90, Day 180 Presence of periodontal attachment loss in the furcation area of multi-rooted teeth, recorded according to Lindhe´s classification: I: the probe penetrates less than one third of the horizontal dimension of the tooth; II: the probe penetrates more than one third of the horizontal dimension of the tooth; III: the probe penetrates through and through the tooth.
Number of present teeth Day 0 (baseline), Day 30, Day 90, Day 180 Number of teeth present in mouth.
Radiographic bone loss Day 0 (baseline) Percentage of bone loss around teeth measured in an orthopantomography (\<30%, 30-50%, \>50%).
Trial Locations
- Locations (2)
Severo Ochoa Hospital
🇪🇸Leganes, Madrid, Spain
Faculty of dentistry, Complutense University Madrid
🇪🇸Madrid, Spain