Clinical trial NCT01609725: Periodontal Therapy in Coronary Artery Patients
Official title: Impact of Periodontal Therapy in Flow-mediated Dilation and Serum Levels of Cardiovascular Risk Biomarkers in Coronary Artery Disease Patients: 12 Months Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Atheroma
Coronary Artery Disease
Keywords: Coronary artery disease
C reactive protein
Periodontitis
Periodontal therapy
Flow-mediated dilation
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 93
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Gingival inflammation has been associated with cardiovascular diseases, including heart attack and stroke, because of elevation of blood risk markers such as cholesterol, glucose and C reactive protein. The treatment of gingival diseases decreases the concentration of these risk factors in the blood of cardiovascular patients.


Eligibility criteria: Inclusion Criteria:

* 35 years and older
* coronary artery disease
* more than 10 teeth
* chronic periodontitis defined as 2 non-adjacent teeth with probing depth 5+mm and periodontal attachment loss 4+mm

Exclusion Criteria:

* use of antibiotics in the last 6 months
* periodontal therapy in the last 12 months

Primary outcomes:
measure: Changes in C reactive protein
timeFrame: Baseline, 3, 6 and 12 months
measure: Changes in flow-mediated dilation
timeFrame: Baseline, 1, 3 and 6 months
Secondary outcomes:
measure: Changes in Interleukin 1B concentrations
timeFrame: Baseline, 3, 6, 12 months
measure: Changes in TNF alpha
timeFrame: Baseline, 3, 6, 12 months
measure: Changes in Interleukin 8
timeFrame: Baseline, 3, 6, 12 months
measure: Changes in Interleukin 6
timeFrame: Baseline, 3, 6, 12 months
measure: Changes in Cholesterol
timeFrame: Baseline, 3, 6, 12 months
measure: Changes in Glycated hemoglobin
timeFrame: Baseline, 3, 6, 12 months
measure: Changes in LDL/HDL
timeFrame: Baseline, 3, 6, 12 months
measure: Changes in Fibrinogen
timeFrame: Baseline, 3, 6, 12 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul, School of Dentistry and University Hospital
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul, Periodontology
name: Alex N Haas, PhD
role: STUDY_CHAIR
affiliation: Federal University of Rio Grande do Sul, Periodontology
name: Cassiano K Rosing, PhD
role: STUDY_CHAIR
affiliation: Federal University of Rio Grande do Sul, Cardiology
name: Carisi Polanczyk, PhD
role: STUDY_CHAIR
affiliation: Federal University of Rio Grande do Sul
name: Eneida RR Rabelo da Silva, PhD
role: STUDY_CHAIR
affiliation: Federal University of Rio Grande do Sul, Cardiology
name: Marco A Saffi, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Rio Grande do Sul, Periodontology
name: Cassio Kampits, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Rio Grande do Sul, Periodontology
name: Ingrid Sanada, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Rio Grande do Sul, Periodontology
name: Marlon Montenegro, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Rio Grande do Sul, Cardiology
name: Mariana V Furtado, MS
role: STUDY_DIRECTOR
References:
citation: Ramirez JH, Arce RM, Contreras A. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. Trials. 2011 Feb 16;12:46. doi: 10.1186/1745-6215-12-46.
citation: Paraskevas S, Huizinga JD, Loos BG. A systematic review and meta-analyses on C-reactive protein in relation to periodontitis. J Clin Periodontol. 2008 Apr;35(4):277-90. doi: 10.1111/j.1600-051X.2007.01173.x. Epub 2008 Feb 20.
citation: Blaizot A, Vergnes JN, Nuwwareh S, Amar J, Sixou M. Periodontal diseases and cardiovascular events: meta-analysis of observational studies. Int Dent J. 2009 Aug;59(4):197-209.
citation: Lockhart PB, Bolger AF, Papapanou PN, Osinbowale O, Trevisan M, Levison ME, Taubert KA, Newburger JW, Gornik HL, Gewitz MH, Wilson WR, Smith SC Jr, Baddour LM; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Council on Clinical Cardiology. Periodontal disease and atherosclerotic vascular disease: does the evidence support an independent association?: a scientific statement from the American Heart Association. Circulation. 2012 May 22;125(20):2520-44. doi: 10.1161/CIR.0b013e31825719f3. Epub 2012 Apr 18.
citation: Montenegro MM, Ribeiro IWJ, Kampits C, Saffi MAL, Furtado MV, Polanczyk CA, Haas AN, Rosing CK. Randomized controlled trial of the effect of periodontal treatment on cardiovascular risk biomarkers in patients with stable coronary artery disease: Preliminary findings of 3 months. J Clin Periodontol. 2019 Mar;46(3):321-331. doi: 10.1111/jcpe.13085. Epub 2019 Mar 6.
citation: Saffi MA, Furtado MV, Montenegro MM, Ribeiro IW, Kampits C, Rabelo-Silva ER, Polanczyk CA, Rosing CK, Haas AN. The effect of periodontal therapy on C-reactive protein, endothelial function, lipids and proinflammatory biomarkers in patients with stable coronary artery disease: study protocol for a randomized controlled trial. Trials. 2013 Sep 6;14:283. doi: 10.1186/1745-6215-14-283.