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Periodontal and Cardiovascular Diseases Project

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ClinicalTrials.gov Identifier: NCT02716259
Recruitment Status : Unknown
Verified May 2018 by Prof. Elena Figuero, Universidad Complutense de Madrid.
Recruitment status was:  Recruiting
First Posted : March 23, 2016
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Prof. Elena Figuero, 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.

Condition or disease Intervention/treatment Phase
Periodontitis Cardiovascular Diseases Procedure: Scaling and root planing Procedure: Supragingival prophylaxis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Basic Periodontal Therapy in the Levels of Porphyromonas Gingivalis and Aggregatibacter Actinomycetemcomitans Subgingival and Its Association With Vascular Function
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Scaling and root planing
Two sessions of scaling and root planing under local anesthesia and oral antiseptics (clorhexidine 0.12% rinse),
Procedure: Scaling and root planing
Two sessions of scaling and root planing under local anesthesia and clorhexidine rinse twice/day, 15 days
Other Name: Clorhexidine rinse (0.12%) (Perio-Aid, Dentaid, Spain)

Placebo Comparator: Supragingival prophylaxis
Two sessions of supragingival prophylaxis under local anesthesia and an oral rinse with no antiseptic properties.
Procedure: Supragingival prophylaxis
Two sessions of scaling and root planing under local anesthesia and sodium fluoride rinse, twice/day, 15 days
Other Name: Sodium fluoride rinse (Fluor-Aid, Dentaid, Spain)




Primary Outcome Measures :
  1. Flow mediated dilation of the brachial artery [ Time Frame: 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 :
  1. Carotid artery atherosclerosis [ Time Frame: 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.

  2. Periodontal pocket probing depth [ Time Frame: 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.

  3. Gingival recession [ Time Frame: 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.

  4. Plaque index [ Time Frame: 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.

  5. Bleeding on probing index [ Time Frame: 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.

  6. Suppuration on probing index [ Time Frame: 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.

  7. Dental mobility [ Time Frame: 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.

  8. Furcation lesions [ Time Frame: 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.

  9. Number of present teeth [ Time Frame: Day 0 (baseline), Day 30, Day 90, Day 180 ]
    Number of teeth present in mouth.

  10. Radiographic bone loss [ Time Frame: Day 0 (baseline) ]
    Percentage of bone loss around teeth measured in an orthopantomography (<30%, 30-50%, >50%).

  11. Bacteria in gingival crevicular fluid [ Time Frame: 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

  12. Bacteria in blood samples [ Time Frame: 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

  13. Inflammatory biomarkers in serum samples [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716259


Contacts
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Contact: Ana Molina, Mrs 0034647486381 anamolinavillar@gmail.com
Contact: Nagore Ambrosio, Mrs 0034628514105 nagoreamb@gmail.com

Locations
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Spain
Severo Ochoa Hospital Recruiting
Leganes, Madrid, Spain
Contact: María Molina, Dr       mariamovi@hotmail.com   
Sub-Investigator: Belén Terol, Physician         
Sub-Investigator: Carmen Rico, Physician         
Principal Investigator: María Molina, Dr         
Faculty of dentistry, Complutense University Madrid Active, not recruiting
Madrid, Spain, 28040
Sponsors and Collaborators
Universidad Complutense de Madrid
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Mariano Sanz, Professor Faculty of Dentistry, Complutense University of Madrid
Principal Investigator: David Herrera, Professor Faculty of Dentistry, Complutense University of Madrid
Study Director: Elena Figuero, Professor Faculty of Dentistry, Complutense University of Madrid
Study Chair: María Molina, Doctor Servicio de Cardiología, Hospital Universitario Severo Ochoa
Publications:
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Responsible Party: Prof. Elena Figuero, Assistant Professor, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT02716259    
Other Study ID Numbers: 14/120-E_BS
PI11/00542 ( Other Grant/Funding Number: Instituto de Salud Carlos III )
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Prof. Elena Figuero, Universidad Complutense de Madrid:
Periodontitis
Cardiovascular diseases
Bacteremia
Scaling and root planing
Flow-mediated dilation
carotid intima-media thickness
Porphyromonas gingivalis
Aggregatibacter actinomycetemcomitans
Additional relevant MeSH terms:
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Periodontitis
Cardiovascular Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Fluorides
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs