Periodontal and Cardiovascular Diseases Project

Cardiovascular Diseases Clinical Trial

Official title:

Impact of Basic Periodontal Therapy in the Levels of Porphyromonas Gingivalis and Aggregatibacter Actinomycetemcomitans Subgingival and Its Association With Vascular Function

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02716259
• Other study ID #: 14/120-E_BS
• Secondary ID: PI11/00542
• Status: Terminated
• Phase: N/A
• Start date: February 19, 2016
• Est. completion date: February 20, 2020

Study information

• Verified date: May 2024
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: February 20, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Periodontitis

Intervention

Procedure:
• Scaling and root planing
Two sessions of scaling and root planing under local anesthesia and clorhexidine rinse twice/day, 15 days
• Supragingival prophylaxis
Two sessions of scaling and root planing under local anesthesia and sodium fluoride rinse, twice/day, 15 days

Locations

Country	Name	City	State
Spain	Severo Ochoa Hospital	Leganes	Madrid
Spain	Faculty of dentistry, Complutense University Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. Erratum In: N Engl J Med. 2018 Jun 13;:null. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	Day 0 (baseline), Day 30, Day 90, Day 180
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of present teeth	Number of teeth present in mouth.	Day 0 (baseline), Day 30, Day 90, Day 180
Secondary	Radiographic bone loss	Percentage of bone loss around teeth measured in an orthopantomography (<30%, 30-50%, >50%).	Day 0 (baseline)
Secondary	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
Secondary	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)
Secondary	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