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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Two sessions of scaling and root planing under local anesthesia and clorhexidine rinse twice/day, 15 days
Two sessions of scaling and root planing under local anesthesia and sodium fluoride rinse, twice/day, 15 days
Severo Ochoa Hospital
Leganés, Madrid, Spain
Faculty of dentistry, Complutense University Madrid
Madrid, Spain
Flow mediated dilation of the brachial artery
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.
Time frame: Day 0 (Baseline), Day 90, Day 180
Carotid artery atherosclerosis
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.
Time frame: Day 0 (Baseline), Day 90, Day 180
Periodontal pocket probing depth
Distance from the gingival margin to the base of the periodontal pocket, measured in 6 sites per tooth with a periodontal probe UNC-15.
Time frame: Day 0 (baseline), Day 30, Day 90, Day 180
Gingival recession
Distance from the gingival margin to the cementum-enamel junction, measured in 6 sites per tooth with a periodontal probe UNC-15.
Time frame: Day 0 (baseline), Day 30, Day 90, Day 180
Plaque index
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.
Time frame: Day 0 (baseline), Day 30, Day 90, Day 180
Bleeding on probing index
Presence or absence of bleeding 30 seconds after probing, measured in 6 sites per tooth with a periodontal probe UNC-15.
Time frame: Day 0 (baseline), Day 30, Day 90, Day 180
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Suppuration on probing index
Presence or absence of gingival suppuration 30 seconds after probing, measured in 6 sites per tooth with a periodontal probe UNC-15.
Time frame: Day 0 (baseline), Day 30, Day 90, Day 180
Dental mobility
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.
Time frame: Day 0 (baseline), Day 30, Day 90, Day 180
Furcation lesions
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.
Time frame: Day 0 (baseline), Day 30, Day 90, Day 180
Number of present teeth
Number of teeth present in mouth.
Time frame: Day 0 (baseline), Day 30, Day 90, Day 180
Radiographic bone loss
Percentage of bone loss around teeth measured in an orthopantomography (\<30%, 30-50%, \>50%).
Time frame: Day 0 (baseline)
Bacteria in gingival crevicular fluid
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
Time frame: Day 0 (baseline), Day 180
Bacteria in blood samples
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
Time frame: Day 1 (pre and post-therapy)
Inflammatory biomarkers in serum samples
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).
Time frame: Day 1, Day 3, Day 10, Day 180