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| ID | Type | Description | Link |
|---|---|---|---|
| PI11/00542 | Other Grant/Funding Number | Instituto de Salud Carlos III |
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Study population was insufficient to provide an adequate pool of patients. All included patients were treated and followed, but the overall desired sample size was not achieve
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scaling and root planing | Experimental | Two sessions of scaling and root planing under local anesthesia and oral antiseptics (clorhexidine 0.12% rinse), |
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| Supragingival prophylaxis | Placebo Comparator | Two sessions of supragingival prophylaxis under local anesthesia and an oral rinse with no antiseptic properties. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and root planing | Procedure | Two sessions of scaling and root planing under local anesthesia and clorhexidine rinse twice/day, 15 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 (Baseline), Day 90, Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 (Baseline), Day 90, Day 180 |
| Periodontal pocket probing depth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariano Sanz, Professor | Faculty of Dentistry, Complutense University of Madrid | Principal Investigator |
| David Herrera, Professor | Faculty of Dentistry, Complutense University of Madrid | Principal Investigator |
| Elena Figuero, Professor | Faculty of Dentistry, Complutense University of Madrid | Study Director |
| María Molina, Doctor | Servicio de Cardiología, Hospital Universitario Severo Ochoa | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severo Ochoa Hospital | Leganés | Madrid | Spain | |||
| Faculty of dentistry, Complutense University Madrid |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17329698 | Background | 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. | |
| 39996093 | Derived | Molina A, Ambrosio N, Molina M, Montero E, Virto L, Herrera D, Figuero E, Sanz M. Effect of periodontal therapy on endothelial function and serum biomarkers in patients with periodontitis and established cardiovascular disease: a pilot study. Front Oral Health. 2025 Feb 10;6:1488941. doi: 10.3389/froh.2025.1488941. eCollection 2025. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D002318 | Cardiovascular Diseases |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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|
| Supragingival prophylaxis | Procedure | Two sessions of scaling and root planing under local anesthesia and sodium fluoride rinse, twice/day, 15 days |
|
|
Distance from the gingival margin to the base of the periodontal pocket, measured in 6 sites per tooth with a periodontal probe UNC-15. |
| 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. | 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. | 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. | Day 0 (baseline), Day 30, Day 90, Day 180 |
| 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. | 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. | 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. | Day 0 (baseline), Day 30, Day 90, Day 180 |
| Number of present teeth | Number of teeth present in mouth. | 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%). | 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 | 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 | 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). | Day 1, Day 3, Day 10, Day 180 |
| Madrid |
| 28040 |
| Spain |
| D001423 |
| Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |