Periodontitis, Cardiovascular Diseases
Conditions
Keywords
Periodontitis, Cardiovascular diseases, Bacteremia, Scaling and root planing, Flow-mediated dilation, carotid intima-media thickness, Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans
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.
Interventions
PROCEDUREScaling and root planing
Two sessions of scaling and root planing under local anesthesia and clorhexidine rinse twice/day, 15 days
PROCEDURESupragingival prophylaxis
Two sessions of scaling and root planing under local anesthesia and sodium fluoride rinse, twice/day, 15 days
Sponsors
Instituto de Salud Carlos III
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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%). |
| 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 |
| 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 |
| 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). |
| 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. |
Countries
Spain
Outcome results
None listed