Periodontal Therapy in Coronary Artery Patients

Coronary Artery Disease Clinical Trial

— PerioCardio  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609725
• Other study ID #: HCPA110146
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2017

Study information

• Verified date: September 2019
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atheroma
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Plaque, Atherosclerotic

Intervention

Device:
• Subgingival scaling and root planing
Oral hygiene instruction and motivation will be provided altogether with scaling and root planing of all teeth affected by periodontitis under local anesthesia
• Oral prophylaxis
One session of supraginigval calculus removal

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Sul, School of Dentistry and University Hospital	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. Review. — View 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. — View 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. Review. — View Citation

Ramírez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in C reactive protein		Baseline, 3, 6 and 12 months
Primary	Changes in flow-mediated dilation		Baseline, 1, 3 and 6 months
Secondary	Changes in Interleukin 1B concentrations		Baseline, 3, 6, 12 months
Secondary	Changes in TNF alpha		Baseline, 3, 6, 12 months
Secondary	Changes in Interleukin 8		Baseline, 3, 6, 12 months
Secondary	Changes in Interleukin 6		Baseline, 3, 6, 12 months
Secondary	Changes in Cholesterol		Baseline, 3, 6, 12 months
Secondary	Changes in Glycated hemoglobin		Baseline, 3, 6, 12 months
Secondary	Changes in LDL/HDL		Baseline, 3, 6, 12 months
Secondary	Changes in Fibrinogen		Baseline, 3, 6, 12 months

External Links

•   School of Dentistry homepage
•   University Hospital homepage